Volume 2: Issue 6 - December 2023
woundmasterclass.com Open Access | Peer Reviewed | International | Quarterly ISSN 2753-6963
Searching for the Resilient Option in Healing
Should Electrical Stimulation be Considered in Synergy with Compression Therapy? A Versatile Framework to Implement Wound Care Competency Programs How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers Role of TLC-NOSF Dressings to Optimize Healing in Diabetic Foot Ulcers
Masterclass GUIDES
Allograft Placental Matrix
M.O.I.S.T. Wound Educational Model
Allograft Dermal Matrix
Wound Cleaning Products Official Journal of the Association for the Advancement of Wound Care®
Editorial Board
United Kingdom & Europe Dr Negin Shamsian
Prof Dimitri Beeckman
Dr Przemysław Lipiński
Prof Dr C. Can Cedidi
Dr Guido Ciprandi
Consultant Plastic & Reconstructive Surgeon (Locum)
Professor of Nursing Science, Ghent University (Belgium) and Vice-Head of the School of Health Sciences, Örebro University (Sweden)
Wound Surgeon, National Representative of Poland in D-Foot International
Clinic Director for Plastic, Reconstructive & Aesthetic Surgery
Professor of Wound Care at the Universities of Rome, Pavia, Turin, Trieste and Pisa
Łódź, Poland
Bremen, Germany
Specialist in thoracic surgery and pediatric surgery
Chief Editor of Wound Masterclass
Ghent, Belgium
London, United Kingdom
Rome, Italy
Dr Paul Chadwick
Mr Harm Jaap Smit
Ms Lian Stoeldraaijers
Prof Declan Patton
National Clinical Director, Royal College of Podiatry
Wound Biologist, Erasmus MC Academy Rotterdam
President, Dutch Association of Diabetes Podiatrists
Manchester, United Kingdom
Rotterdam, Netherlands
Valkenswaard, Netherlands
Director of Nursing and Midwifery Research and Deputy Director of SWaT Research Center, RCSI University of Medicine and Health Sciences Dublin, Ireland
Prof Jan Kottner
Prof Dr Luca Dalla Paola
Dr Sebastian Probst
Prof Dr Marco Romanelli
Professor of Nursing Science, Charité - Berlin University of Medicine
Specialist in Endocrinology, Metabolic Diseases and Diabetology
EWMA President
Berlin, Germany
Expert in medical and surgical treatment of Diabetic Foot
Full Professor and Chairman, Division of Dermatology, Department of Clinical and Experimental Medicine, University of Pisa
Ferrara, Italy
Professor of Tissue Viability and Wound Care at the School of Health Sciences, University of Applied Sciences and Arts Western Switzerland, Geneva
Pisa, Italy
Genf, Switzerland
North America Mr Frank Aviles
Ms Kara Couch
Dr Kenneth Burhop
Mr Tobe Madu
Wound Care Clinical Coordinator, Natchitoches Regional Medical Center
President-Elect, Association for the Advancement of Wound Care
Life Sciences Advisor and Consultant
Data Scientist, Net Health
Associate Research Professor of Surgery, School of Medicine and Health Studies George Washington University
Natchitoches LA, United States
San Diego CA, United States
Atlanta GA, United States
Director, Wound Care Services, The George Washington University Hospital
Arlington VA, United States
Dr Windy Cole
Dr M. Mark Melin
Dr Leo Nherera
Dr Brandon Bosque
Director of Wound Care Research, Kent State University of Podiatric Medicine
Medical Director of the M Health Wound Healing Institute
Director, Global Head of Health Economics & Outcomes Research
Foot and Ankle Surgeon
National Director of Clinical Safety, Quality and Education, Woundtech
Adjunct Associate Professor, University of Minnesota Surgical Department
Fort Worth TX, United States
Streetsboro OH, United States
Philadelphia PA, United States
Mineapolis MN, United States
Dr Mitch Sanders
Prof David Armstrong
Dr Aliza Lee
Dr Alton R. Johnson
CSO and EVP Alira Health. CEO of WoundForce Inc. and Firefly Innovations LLC.
Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA), Keck School of Medicine of USC
Clinical Research Investigator, Department of Veterans Affairs
Podiatric Surgeon
Salem VA, United States
Ann Arbor MI, United States
Boston MA, United States
Los Angeles CA, United States
Dr Jonathan Johnson
Dr David Alper
Dr Ruth Bryant
Surgical Director, Comprehensive Wound Care Services
Trustee - Board of Trustees, American Podiatric Medical Association
Nurse Scientist and WOC nurse, Abbott Northwestern Hospital
Board Member - American Diabetes Association (New England)
Washington DC, United States
Surgical staff (Emeritas) - Mount Auburn Hospital Cambridge, MA, United States
Minneapolis MN, United States
Boston MA, United States
East Asia
Australia
South & Central America
Dr Joon Pio Hong
Dr Ross D Farhadieh
Professor of Plastic and Reconstructive Surgery at the University of Ulsan College of Medicine and Asan Medical Center
Cosmetic Plastic & Reconstructive Surgeon Sydney, Australia
Prof Dr Harikrishna K. R. Nair President Elect, WUWHS - World Union of Wound Healing Societies
Ms Terry Swanson
Dr Eduardo Camacho
Vice Chair, International Wound Infection Institute
Plastic and Reconstructive Surgeon
Victoria, Australia
Mexico City, Mexico
President, Asia Pacific Association of Diabetic Limb Problems Kuala Lumpur, Malaysia
Dr Honda Hsu Plastic Surgeon and Associate Professor, Tzu Chi General Hospital Hualien, Taiwan
Middle East Sr Trish Idensohn
Prof Amit Gefen
Wound Nurse Specialist, Consultant and Educator
Professor of Biomedical Engineering, Tel Aviv University
Durban, South Africa
Head and Neck Surgeon, Associate Professor Instituto Universitario Hospital Italiano Buenos Aires, Argentina
Seoul, South Korea
Africa
Dr Luis Alejandro Boccalatte
Tel Aviv, Israel
Wound Care Physician
December 2023
Chief Editor Miss Negin Shamsian Commercial Director Mr Alec Wright Contact Editor
Searching for the Resilient Option in Healing | Dr Negin Shamsian
3
Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications | Dr M. Mark Melin, Dr Heather Barnhart, Mr Frank Aviles, Ms Sabrina Ginsburg
4
Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane | Dr Alton R. Johnson, Mr Shenlone Wu, Ms Briana Lay
12
Evolution of Dressing Change Frequency for Patients with Wounds | Dr Negin Shamsian
22 - 23
Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy? | Dr Keith Gordon Harding
24 - 27
Role of TLC-NOSF Dressings to Optimize Healing in Diabetic Foot Ulcers | Ms Michelle Goodeve, Ms Laura Saunders
32 - 36
A Versatile Framework to Quickly Implement Wound Care-Specific, RoleBased Competency Programs | Dr Elaine H. Song, Ms Catherine T. Milne, Ms Tiffany Hamm, Ms Nataliya Lebedinskaya, Ms Janis Prado, Mr Jeff Mize
38 - 39
How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide | Mr John Timmons, Dr Matthew Malone, Prof Dr Joachim Dissemond
40 - 52
Global Innovation in Wound Care Summit Series: Biofilm Masterclass
58 - 61
Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?
62 - 67
MasterSeries 60 Minutes Interactive: Clinical Challenges and Solutions in Palliative Wound Management
70 - 80
Biodegradable Matrix Offers Limb-Saving Option for Chronic Ischaemia | Ms Victoria Bristow
82 - 84
What Is the Role of Platelet-Derived Biologics? | Prof Anand Pillai, Dr Vish Kumar
85 - 87
MasterSeries 60 Minutes Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation
88 - 102
editor@woundmasterclass.com
Commercial Inquiries commercial@woundmasterclass.com
Article Submissions submissions@woundmasterclass.com
Published by Clarus Communications Ltd., Oxford, United Kingdom No part of this issue is to be copied or reproduced without permission of the publisher © Clarus Communications Ltd.
This publication is intended for online distribution and this issue is not suitable for print in this form To inquire about obtaining a printable version of this issue or any article therein, please contact the editor
Cover image:
Masterclass GUIDES Licenced from Adobe Stock Credit: psynovec
Allograft Placental Matrix
8 - 11
Allograft Dermal Matrix
18- 21
Wound Cleaning Products
28 - 31
M.O.I.S.T. Wound Educational Model
54 - 57
Time to heal diabetic foot ulcers 50% 1 shorter than with standard of care – with Granulox®
Learn more about what Granulox® can do for your patients: www.molnlycke.com/granulox References: 1. Hunt, SD., Elg, F. Clinical effectiveness of hemoglobin spray (Granulox®) as adjunctive therapy in the treatment of chronic diabetic foot ulcers. November 2016. Mölnlycke Health Care AB, P.O. Box 13080, Gamlestadsvägen 3 C, SE-402 52 Göteborg, Sweden. Phone + 46 31 722 30 00. The Mölnlycke and Granulox trademarks, names and logos are registered globally to one or more of the Mölnlycke Health Care Group of Companies. © 2021 Mölnlycke Health Care AB. All rights reserved. HQIM002731
Searching for the Resilient Option in Healing December 2023 As wound care clinicians, we constantly face challenges in healing our patients' wounds. Chronic wounds that fail to progress through the normal stages of healing require us to look beyond the standard limitations in our treatment options. However, focusing our efforts on searching for the resilient factor in wound healing may provide a better path forward. Rather than viewing wounds that are stalled in the inflammatory stage as failures, shifting our perspective to see them as adaptations may enable us to tackle them from a different perspective. The wound is stuck attempting to protect itself from further harm. By identifying the barriers preventing the wound from healing and providing targeted interventions to reduce inflammation and infection, we can support the wound’s innate resilience mechanisms. Removing these impediments allows the body’s robust self-healing abilities to bring the wound back onto a healing trajectory. Viewing wound healing through a lens of resilience enables us to collaborate with our patients’ physiology rather than fighting against it. This approach directs us to search for interventions that align with the wound’s natural resilience factors. In doing so, we may find more effective treatments that do not override but rather unlock the body's intrinsic capacity to heal.
A
s we approach the end of 2023, the Wound Masterclass team wishes to express our deep gratitude to all those who contributed to making this year an impactful one in wound care research and education. We sincerely thank our dedicated readers, subscribers, authors, peer reviewers, partners, and collaborators worldwide. Together, through sharing free online access and knowledge in the Wound Masterclass Journal, Innovation Summit Series, Interactive MasterSeries, and Podcast, we have made great progress in improving patient outcomes related to wound prevention, assessment, treatment, and healing. We have had record global engagement and we are the first fully sustainable free global wound care journal. This year, we published over 100 insightful articles, studies, commentaries, and best practices that have the potential to meaningfully advance wound care and quality of life for millions. We have also seen record levels of global engagement and readership. We are honored to play a role in disseminating vital clinical work to wound care professionals across borders. As the calendar year draws to a close, it is worthwhile to pause and reflect on the advances made in wound care in 2023. Despite the ongoing challenges of the pandemic, this year saw several impactful developments that give hope for continued progress in promoting healing and improving patient quality of life. Several articles in this winter issue of Wound Care Journal highlight recent successes. The use of biodegradable temporizing matrices,
© Copyright. Wound Masterclass. 2023
possibilities for treating chronic limb ischemia and temporizing tissue loss. Research by Alton Johnson et al. on the comparative effectiveness of amniotic membranes represents important work toward optimizing standard protocols for venous leg ulcers and diabetic foot ulcers. And work by Michelle Goodeve et al. demonstrates the potential for TLC-NOSF dressings to enhance diabetic ulcer healing. While more work remains, the progress made this year reinforces the power of partnership and discovery to transform patient lives. As we venture into a new year, I am energized by the innovations featured at this year's Wound Masterclass Global Innovation in Wound Care Summit Series, Wound Masterclass MasterSeries 60 Minutes Interactive, The Wound Masterclass Podcast, and in the pages of this journal issue. Our community's dedication gives me optimism that each year will bring us closer to definitive solutions for even the most complex wounds. I look forward to seeing what we can accomplish together in 2024. Ultimately, this progress would not be possible without all of you. We look forward to continuing this collaborative mission in the years ahead as we learn, grow, and serve patients, clinicians and researchers worldwide. We wish you happy holidays and a wonderful start to 2024! With gratitude from the entire Wound Masterclass team.
Dr Negin Shamsian Consultant Plastic & Reconstructive Surgeon (Locum) Chief Editor of Wound Masterclass London, United Kingdom
Wound Masterclass - Vol 2 - December 2023
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Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications Editorial Summary In space, astronauts experience fluid shifts from their legs to their upper body, causing symptoms like head fullness and vision changes known as Spaceflight Associated Neuroocular Syndrome (SANS). NASA researchers are studying SANS using analog tests that simulate space conditions. They use noninvasive imaging techniques to monitor fluid shifts and develop countermeasures. These techniques could also be useful in improving wound care by diagnosing lymphatic dysfunction and edema. NASA's research in nutrition and other areas can benefit healthcare. By adopting advanced technologies, similar to the James Webb telescope, wound clinics can achieve better outcomes.
Introduction
S Dr M. Mark Melin
Dr Heather Barnhart
Medical Director of the M Health Wound Healing Institute
Professor, Dept of Physical Therapy, Nova Southeastern University
Adjunct Associate Professor, University of Minnesota Surgical Department Mineapolis MN, United States
Fort Lauderdale FL, United States
pace travel poses unique challenges for astronauts, including significant fluid shifts from the legs to the upper body, leading to symptoms such as head ‘fullness’ and altered vision. This condition, known as Spaceflight Associated Neuroocular Syndrome (SANS), is a priority area of research for NASA as they plan future missions to the moon and Mars. Earthbased studies use space flight analogue testing to simulate these fluid shifts, but real-time imaging of fluid shifts in a head-down position has been lacking. Recent advancements in noninvasive imaging techniques have shown promise in monitoring fluid shifts and understanding SANS. Additionally, these imaging technologies hold potential for improving diagnostics and treatments in wound care, particularly for conditions like venous leg ulcerations and lymphedema. By applying lessons learned from space research, we can explore innovative approaches and enhance patient outcomes in wound care.
Fluid Shifts in Low Earth Orbit (LEO) Entering Low Earth Orbit (LEO) induces a significant fluid shift in astronauts, where approximately 2 litres of fluid move from the legs to the upper torso, neck, and head. This fluid shift occurs within the first 24 hours in LEO and is followed by human physiology adaptation over the following 7 days. However, the resolution of fluid shifts varies, and complete improvement is not always achieved.
Mr Frank Aviles
Ms Sabrina Ginsburg
Wound Care Clinical Coordinator, Natchitoches Regional Medical Center
University of Miami Miller School of Medicine HPSP Student
Natchitoches LA, United States
Lake Worth, Florida, United States
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Wound Masterclass - Vol 2 - December 2023
Symptoms of Spaceflight Associated Neuroocular Syndrome (SANS) Astronauts in space experience various symptoms associated with Spaceflight Associated Neuroocular Syndrome (SANS). These symptoms include a sense of ‘fullness’ in the head, stuffy nose, and altered taste sensation. Furthermore, approximately 40 - 70% of the crew develops varying symptoms of SANS. The syndrome leads to ocular, retinal, and vision changes, retinal nerve thickening, and alterations in fluid distribution within the
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Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications
“By providing valuable insights into fluid distribution associated with different body positions (head down vs. supine vs. sitting up), noninvasive imaging techniques can contribute to improved diagnosis, treatment, and prevention of SANS."
brain, including cerebrospinal fluid shifts.
Recent Head Down Tilt Analogue Study
Causes and Priorities for Investigating SANS
Our team recently conducted a head-down tilt spaceflight analogue study to examine fluid shifts in volunteers. In this study, we utilized long wave infrared thermography, Near-Infrared Spectroscopy (NIRS), and a subcutaneous edema monitor. These imaging techniques are current standard options in wound clinics and readily available for point-of-care diagnostics.
The cause of SANS is hypothesized to be multifactorial, involving factors such as genetics, altered micronutrient pathways, elevated CO2 exposure on the International Space Station, increased radiation exposure, and alterations in androgen hormones. Currently, there are no fully effective countermeasures for SANS. As astronauts plan future ventures to the moon's surface and long-duration spaceflights to Mars, the investigation of SANS and the development of reliable treatments have become among the highest priorities for NASA researchers.
Space Flight Analogue Inducing Fluid Shifts
Testing
and
To understand the causes and effects of fluid shifts in space, researchers perform Earth-based research using volunteers involved in space flight analogue testing. One type of analogue testing involves placing volunteers on a bed with a 6-degree head-down tilt to simulate fluid shifts from the legs to the torso, head, and neck, mimicking certain aspects of being in LEO. It is important to note that this analogue testing does not replicate ‘true weightlessness' experienced by astronauts in spaceflight. Nonetheless, it is a validated model capable of inducing symptoms of SANS.
Potential of Noninvasive Imaging for Fluid Shift Monitoring and Countermeasure Development The utilization of validated noninvasive imaging devices holds promise in monitoring fluid shift patterns in real-time. These devices can assist in further understanding the dynamics of fluid shifts and contribute to the development of countermeasures for SANS. By providing valuable insights into fluid distribution associated with different body positions (head down vs. supine vs. sitting up), noninvasive imaging techniques can contribute to improved diagnosis, treatment, and prevention of SANS. Figure 1: Body lymphatics.
Limitations of Current Analogue Testing Methods Although analogue testing can induce symptoms of SANS, there is a limitation when it comes to real-time noninvasive imaging of the fluid shifts accompanying the head-down position. To date, such imaging has not been completed, presenting a gap in understanding the dynamics of fluid shifts during simulated space conditions.
© Copyright. Wound Masterclass. 2023
Wound Masterclass - Vol 2 - December 2023
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Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications
“Embracing noninvasive imaging technologies represents a paradigm shift in wound care, providing clinicians with valuable insights into the comprehensive pathophysiology of wounds and enabling targeted interventions for optimal patient care.”
Significance of Gravity-Induced Fluid Shifts in Wound Care In the field of wound care, we encounter patients daily who experience significant fluid shifts influenced by the constant pull of gravity. Conditions such as venous leg ulcerations (VLU), lymphedema associated with VLUs, lymphatic dysfunction in diabetics with foot ulcerations, and other lower extremity chronic wound pathologies, are affected by these fluid shifts. Recognizing the impact of gravity, we emphasize the importance of consistent compression and leg elevation management to improve leg wound outcomes.
Improving Diagnostics for Lymphatic Dysfunction and Edema The potential of noninvasive imaging techniques such as longwave infrared thermography, NIRS, and subcutaneous edema monitors can be harnessed to enhance diagnostics in cases of lymphatic dysfunction and edema associated with leg ulcerations. Lymphedema and resulting diffuse edema significantly compromise lower extremity wound healing and increase wound recidivism rates. However, clinical recognition of lymphedema remains poorly acknowledged in most wound and vein centers, which compromises patient outcomes. By utilizing the entire spectrum of ‘light' beyond human Figure 2: NASA space station.
visible wavelengths, these noninvasive imaging techniques offer a promising approach to improve the recognition and understanding of the underlying pathophysiology, supporting advanced research and enhanced treatments in common wound clinic pathologies.
The Role of Noninvasive Imaging in Enhancing Wound Care Outcomes Noninvasive imaging devices hold great potential as point-of-care tools in wound clinics. By allowing for the recognition and early treatment of lymphatic dysfunction associated with living on Earth in a ‘1G' environment, as well as monitoring fluid shifts to the lowest points of the body, these devices can significantly improve wound care outcomes. Embracing noninvasive imaging technologies represents a paradigm shift in wound care, providing clinicians with valuable insights into the comprehensive pathophysiology of wounds and enabling targeted interventions for optimal patient care.
Healthcare Spinoffs and NASA Research NASA's extensive research efforts have resulted in numerous ‘healthcare spinoffs' that have the potential to benefit the patients we serve. Areas such as nutrition and wound care management, often overlooked, have received considerable attention from NASA. These research endeavors provide valuable knowledge and insights that can be applied to improve healthcare outcomes.
Exploration of Wound Care Management in NASA Research Wound care management is one area where NASA research can contribute significantly. For those interested in delving deeper into the subject, NASA's publication on human adaptation to spaceflight and nutrition in 2021 offers a wealth of knowledge, showcasing the agency's commitment to advancing our
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Wound Masterclass - Vol 2 - December 2023
Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications
“By providing valuable insights into fluid distribution associated with different body positions (head down vs. supine vs. sitting up), noninvasive imaging techniques can contribute to improved diagnosis, treatment, and prevention of SANS."
understanding of spaceflight human adaptive physiology and its implications for healthcare.
Embracing Technological Advances for Enhanced Patient Outcomes Similar to the paradigm shift brought about by the James Webb telescope in our understanding of celestial bodies, incorporating advanced technologies into wound clinics has the
potential to revolutionize treatments and outcomes for the patients we care for. By adopting and integrating ‘James Webb telescope' technology (referring metaphorically to noninvasive imaging devices) into wound clinics, we stand at the threshold of remarkable advancements in wound care. As we embrace these new possibilities, we position ourselves at the forefront of wound care advances, ready to propel patient outcomes to new heights.
References 1. Lee AG, Mader TH, Gibson CR, Brunstetter TJ, Tarver WJ, Spaceflight-associated neuroocular syndrome. JAMA Ophthalmol. 2017;135(5):534-540. 2. Marshall-Bowman K, Barr YR, Herold DM, Barr AM, Schneider JS, Cardenas F. The impact of long-duration spaceflight on neurocognitive functioning: NASA Evidence Report. Aviat Space Environ Med. 2021;92(6):621-628. 3. Alperin N, Bagci AM, Lee SH, Lam BL. Reduced orbital CSF volume in Spaceflight Associated Neuro-Ocular Syndrome (SANS). J Neuroimaging. 2020;30(1):21-27. 4. Zwart SR, Gibson CR, Mader TH, et al. Vision changes after spaceflight are related to alterations in folate- and vitamin B-12-dependent one-carbon metabolism. J Nutr. 2012;142(3):427-431 5. Hargens AR, Bhattacharya R, Schneider SM. Space physiology VI: exercise, artificial gravity, and countermeasure development for prolonged space flight. Eur J Appl Physiol. 2013;113(8):2183-2192 6. Zwart SR, Laurie SS, Chen JJ, et al. Lower body negative pressure treadmill exercise as a countermeasure for bed rest-induced bone loss in female identical twins. Bone. 2020;130:115087. 7. Stenger MB, Platts SH, Ribeiro LC, et al. Resistance exercise training as a countermeasure to disuse-induced bone loss. J Appl Physiol (1985). 2009;107(4):105-113.
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8. Blaber AP, Goswami N, Bondar RL, Kassam MS. Impairment of cerebral blood flow regulation in astronauts with orthostatic intolerance after flight. Stroke. 2011;42(7):1844-1850. 9. Clément G, Ngo-Anh JT. Space physiology and operational space medicine. Annu Rev Physiol. 2011;73:293-320. 10. Watenpaugh DE, Ballard RE, Schneider SM, Lee SM. Human cardiovascular responses to six months of head-down tilt. Aviat Space Environ Med. 2000;71(2):150-157. 11. Yoonessi A, Patwardhan AG, Porter RW, Rekant MS. Magnetic resonance imaging: a threedimensional study of normal talocalcaneal alignment. Foot Ankle Int. 2003;24(10):769-773. 12. Balldin UI, Scott SC, Zajtchuk JT, Hatch TF. Evaluation of venous gas emboli in swine after decompression: Doppler detection and relationship to symptom development. Aviat Space Environ Med. 1985;56(3):241-247. 13. Witte CL, Holdsworth DW, Drangova M. Quantification of the peripheral venous system in humans using high-resolution MR venography. J Appl Physiol (1985). 2005;98(5):2125-2131. 14. Kim SH, Oh TS, Lew DH, Lee HS, Rhie JW. Monitoring of the survival of perforator flaps using indocyanine green angiography: a preliminary study. Arch Plast Surg. 2013;40(5):452-457. 15. Ganchev RN, Novoselov NP, Savel'ev AS. Use of modern diagnostic technologies in examining patients with lower limb lymphedema. Vestn Khir Im I I Grek. 2015;174(2):75-79.
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Masterclass GUIDES Introduction
Allograft Placenta Matrix: AmnioBand® Keywords
This Masterclass guide is a concise overview aimed at exploring the use of AmnioBand® and how to incorporate this into your practice. AmnioBand® is a minimally processed human allograft which retains the structural properties of the extracellular matrix. It contains collagen matrix, growth factors, and endogenous neonatal cells that promote healing which can be utilized for burns, venous ulcers, diabetic foot ulcers, and other complex wounds.
What Is AmnioBand ?
■ Allograft ■ Re-epithelialization ■ Diabetic foot ulcerations ■ Ulcers
■ Wound healing ■ AmnioBand ■ Placenta matrix ■ Membrane ®
Figure 1: AmnioBand® Application Sizes.
®
■ AmnioBand Membrane is intended to be used as a protective ®
covering for internal and external tissue defects including acute, chronic and surgically created wounds1,2
■ This bi-layer amnion and chorion membrane helps in native tissue restoration and remodeling, providing optimal coverage in a wide variety of sizes for all types of acute and chronic wounds
■ Because it’s flexible, it conforms to the wound site with ease and aseptic processing preserves the natural structure2
■ Maintains inherent growth factors, matrix proteins, and endogenous viable cells shown to support host tissue
Figure 2: AmnioBand® Allograft Placental Matrix.
AmnioBand® Preparation Guide ■ AmnioBand Membrane is packaged in a sterilized foil pouch that ®
is designed to be passed directly into the sterile field. Use standard aseptic/sterile technique to open package
1.
Prepare wound area using standard methods to ensure wound is free of debris and necrotic tissue
2.
Peel open chevron seal of outer Tyvek pouch and pass inner foil pouch to sterile field
3.
Peel open chevron seal of inner pouch and remove tissue from inner pouch using sterile gloves/forceps
4.
In a dry state, use sterile dry scissors to trim AmnioBand® Membrane to fit dimensions of application site. It is recommended no more than 0.5mm-2mm overlap over the wound margin
5.
Apply AmnioBand® Membrane directly to patient site. If needed, membrane may be hydrated with sterile saline
6.
Anchor AmnioBand® Membrane with tissue adhesives or by suturing the sheet, ensuring first that graft overlaps adjacent intact skin
7.
Use appropriate, non-adherent, primary dressing and secondary dressing to maintain a moist wound environment and the placement of the tissue
■ NOTE: Ensure wound site is free of debris and necrotic tissue. Debride if necessary prior to graft placement
■ NOTE: Once foil pouch is opened, tissue should be used promptly
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Wound Masterclass - Vol 2 - December 2023
Allograft Placenta Matrix: AmnioBand®
Masterclass GUIDES
What Types of Wounds Are Suitable?
What Types of Wounds Are Not Suitable?
■ Diabetic foot ulcers ■ Venous leg ulcers ■ Pressure ulcers ■ Homologous uses
■ The presence of severe vascular compromise ■ Active or latent infection ■ Uncontrolled infection
Warnings and Precautions ■ Do not sterilize ■ Prescription use only ■ No known sensitizing agents are present in this tissue. NOTE: No
Figure 3: AmnioBand®
antibiotics were used in the processing of this tissue
■ Do not use if container seal is not intact or damaged, if container label or identifying barcode is severely damaged, not legible or missing or if expiration date shown on container label has passed
■ AmnioBand Membrane should be stored at ambient temperature ■ Do not refrigerate or freeze ■ It is the responsibility of the transplant facility or clinician to ®
maintain the tissue intended for transplantation in the appropriate recommended storage conditions prior to transplant
■ Extensive medical screening procedures have been used in the
selection of all tissue donors for the Musculoskeletal Transplant Foundation (MTF) (please see MTF’s Donor Screening and Testing document)
■ Transmission of infectious diseases such as HIV or hepatitis, as well
as a theoretical risk of the Creutzfeldt-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing
Wound Masterclass - Vol 2 - December 2023
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Masterclass GUIDES
Allograft Placenta Matrix: AmnioBand®
What Is the Evidence? Recent clinical results of allografts derived from amnion and chorion placental layers encourage further investigation of the mechanisms underlying clinical efficacy of these products for treatment of wounds. In recent years, there has been a significant increase in the use of amniotic membrane to treat difficult, stubborn lesions such chronic venous leg ulcers.4 The site investigator classified index wounds as healed if complete (100%) epithelialization took place without drainage or the need for treatment.5
Efficacy ■ When applied either weekly or biweekly
to patients with chronic venous leg ulcers, AmnioBand achieved full wound closure in 75 percent of patients over the 12-week period6
Pain ■ In general, chronic wounds exhibit several
■ The study also found the AmnioBand groups
had a significantly higher median percentage wound area reduction of 100% vs 75% wound area reduction in the standard of care alone group at the twelve-week timepoint6
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Wound Masterclass - Vol 2 - December 2023
pathological characteristics not present, or present only to a lesser degree, in healing wounds or in normal skin including excessive matrix degradation through unbalanced MMP/TIMP ratios, unresolved inflammatory responses, persistent wound infection (which can also further prolong the duration of the inflammatory response), and desensitization of wound edges to reparative stimuli via dysfunctional epidermal cell behavior, among many others7,8
Debridement ■ Lowest demonstrated graft cost to closure evidenced by published peerreviewed prospective Level 1 publications
Allograft Placenta Matrix: AmnioBand®
Masterclass GUIDES
Key Points ■ Aseptic processing preserves tissue’s natural structure ■ Ready, right out of the package ■ Can be used in the hydrated or dehydrated state ■ Shelf life of three years at ambient temperature ■ Flexible ■ Conforms to anatomy and maintains surface contact
“Given its modest cost and ability to heal recalcitrant DFUs, the dHACA graft may have clinical applications in patients with even more complex wounds that are deep to tendon and bone.” DiDomenico, et al., 2018 5 “dHACA plus SOC treatment for nonhealing DFUs over 6 and 12 weeks has been shown to heal DFUs significantly faster than SOC with minimal graft wastage.” DiDomenico, et al., 2018 5
References 1. AmnioBand® Viable Membrane, Allograft Placental Matrix. (n.d.). AmnioBand® Viable Membrane, Allograft Placental Matrix. 2. AmnioBand® Membrane. (2015, December 4). WoundSource. 3. ElHeneidy H, Omran E, Halwagy A, Al-Inany H, Al-Ansary M, Gad A. Amniotic membrane can be a valid source for wound healing. Int J Womens Health. 2016 Jun 27;8:22531 4. Kogan S, Sood A, Granick MS. Amniotic membrane adjuncts and clinical applications in wound healing: A review of the literature. Wounds 2018;30:168–173. 5. DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Zelen CM. Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2016 Oct 12;4(10):e1095. doi: 10.1097/GOX.0000000000001095. PMID: 27826487; PMCID: PMC5096542. 6. New Study Finds AmnioBand® Membrane Effectively Heals Venous Leg Ulcers in Less Time. (2022, November 29). New Study Finds AmnioBand&Reg; Membrane Effectively Heals Venous Leg Ulcers in Less Time | Business Wire. 7. P. Martin, R. Nunan, Cellular and molecular mechanisms of repair in acute and chronic wound healing, Br. J. Dermatol. 173 (2) (2015) 370–378. 8. J.N. Brantley, T.D. Verla, Use of placental membranes for the treatment of chronic diabetic foot ulcers, Adv. Wound Care 4 (9) (2015) 545–559.
Useful Links
Use your device to scan this QR code for more information about AmnioBand®
Visit the MTF Biologics website
How to Cite this Article Masterclass Guide: Allograft Placenta Matrix: AmnioBand®. Wound Masterclass. Volume 2. No 7. December 2023
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Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane Editorial Summary This study is a retrospective review of comparative wound size changes when using standard of care (SOC) versus amniotic membrane (AM). The patient group had either non-healing venous leg ulcers (VLU) or diabetic foot ulcers (DFU). The inclusion criteria for this study was patients who had experienced minimal wound size change after 5-weeks of SOC, in effect considering amniotic membrane as an alternative treatment for a further 5-weeks of treatment. The wound sizes were measured at three points: 1) the initial treatment phase with SOC, 2) the end of SOC (after 5 weeks) or the beginning of AM treatment and 3) 5 weeks after the amniotic membrane treatment, as the comparative modality.
Introduction
S
tandard of Care (SOC) for non-healing wounds typically comprises of debridement of necrotic and infected tissue, establishing adequate circulation, maintaining a moist periwound environment, infection control, and offloading or compression dependent on the etiology of the wound itself.1 Standard of Care can vary due to clinician judgement and wound type. It is acknowledged as a time consuming and potentially less efficient method for treating chronic wounds which is why there has been a recent push for evidence based-innovation. One of which is Amniotic Membrane (AM) or amnion. AM has been evidenced in consideration of reconstruction due to the pluripotent properties of AM cells.2 AM has an avascular structure comprising of three layers containing collagen, extracellular matrix, and biologically active cells (mostly stem cells). Collagen is a naturally occurring matrix polymer and provides a structure to the amniotic membrane. Regulated by growth factors such as cytokines, chemokines, and other endogenous cells that are contained in the matrix of AM, this allows for epithelialization.
Dr Alton R. Johnson University of Michigan Ann Arbor MI, United States
The largest organ of the human body, skin is fundamentally the first line of defense, so when we consider the implication of chronic ulcers there is a severe infection risk with any breach of the epithelial surfaces leaving the patient vulnerable to cross contamination of bacteria and a possible site of sepsis. When this protective surface is compromised, it can lead to increased morbidity and mortality and increase the challenge of wound care.
Mr Shenlone Wu
Ms Briana Lay
University of Nevada, Las Vegas (UNLV)
University of California, Los Angeles (UCLA)
Las Vegas NV, United States
Los Angeles CA, United States
The classification of what constitutes a ‘chronic wound' is a wound persisting for more than 6-weeks, where no sign of healing has been highlighted.3 When a patient presents with a chronic wound, a clinician can identify this as they exhibit an stalled healing process that is different to an acute wound. This usually presents in the form of inflammation, wound infection, hypoxia, poor nutrition or possibly a biofilm element. Some of the factors that cause chronic wounds to persist include diabetes, weakened immune systems, and poor blood circulation.
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Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane
“One study found that the combination method of SOC and AM resulted in an improved healing rate for patients with diabetic foot ulcers, in comparison to the use of SOC alone. However, not all chronic wounds result in a complete healing when using amniotic membrane as a method of treatment despite the advantages.”
When we consider non-healing chronic wounds, this is likely due to complications such as infections like cellulitis and/or osteomyelitis.4 In the context of current standard of care for chronic wounds this involves a number of steps, including; wound swabs, debridement of the wound to remove necrotic tissue, and dressing the wound and maintaining a moist environment to encourage healthy tissue re-epithelialization. There has also been advancements and developing technologies in wound care strategies that are now being implemented across the world. During the late 20th Century physicians began to experiment with AM as a form of wound treatment which provided various benefits like anti-inflammatory responses, bacteriostatic response (prevention of reproduction of microorganisms, not necessarily killing the bacteria), and scarprevention properties. These advantages of AM are generated from the cytokines that promote cell proliferation and differentiation.5 The Food and Drug Administration (FDA) has approved the use of AM for venous leg ulcers and diabetic foot ulcers. One main function of the AM is to provide tissue regeneration where there is a balance between the extracellular matrix (ECM), metabolically active cells and cellular signal mediators.6 The membrane itself is rich in collagen which is a protein responsible
for development of healthy joints and skin elasticity, and as we age our bodies produce less and find it equally difficult to continuously produce collagen. Therefore, with chronic wounds in older adults, AM offers a healthy and rich amount of collagen for skin regrowth and elasticity. This includes collagens I, III, IV, V, and VII. In addition, AM provides ECM, elastin, laminin, fibronectin, proteoglycans, and glycosaminoglycans as well as non-viable cells.7 As a matter of fact, AM provides over 200 natural bioactive proteins that are preserved within.8-10 AM itself is a thin and transparent lining of the chorionic layer of the placenta which comprises of two primary layers; an outer layer formed by the trophoblast and an inner layer that is formed by the somatic mesoderm. This allows AM to behave as a bioactive matrix that promotes fibroblasts and endothelial cell production. AM also promotes hematopoietic, mesenchymal and diabetic adipose stem cell migration.11 Combining all efforts, this results in cell proliferation, migration and biosynthesis.12-13 One study found that the combination method of SOC and AM resulted in an improved healing rate for patients with diabetic foot ulcers, in comparison to the use of SOC alone.14 However, not all chronic wounds result in a complete healing when using amniotic membrane as a method of treatment despite the advantages.
Methods Figure 1: 1a: Diabetic foot ulcer. 1b: Venous leg ulcer. 1a
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1b
In this retrospective study between 2018 2021, 23 patients treated by practitioners from Professional Wound Specialists were identified as meeting the inclusion criteria. The age range was from 33 to 89 years of age, 11 of the ulcers were proven to be diabetic foot ulcers, and a further twelve were identified as Venous Leg Ulcer (VLU) patients. The ratio of male to female patients was 18:5. All participants received 5-weeks of SOC followed by 5-weeks of AM applications. They were excluded if any of the following criteria were present:
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Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane The administration of SOC treatment over the first 5-weeks is performed according to the guidelines suggested by the National Center for Biotechnology Information. The treatment options include silver gel, silver or calcium alginate, medical honey, collagenase, antibiotic ointment, negative pressure wound therapy (NPWT) amongst other treatment modalities. The choice of dressing is determined based on drainage percentage and whether the wound is emitting an odor. If the wound size change is insignificant after 5 weeks with SOC, AM is performed once weekly with no local or general anesthetic required for administration.
Exclusion Criteria Wound healing occurred within less than 5-weeks of AM applications Non-compliant patients resulting in an early termination of the study HbA1c of >10 in DFU patients Wounds presenting outwith the proliferation phase (i.e., infections) Disruption in the study such as acute changes to the participants medical status that resulted in a transfer of care
Table 4
Table 1 DFU Patients
Measurement 1
Measurement 2
Measurement 3
1
9 cm
8.7 cm
5.2 cm
2
2
2
15 cm
2
29.2 cm
27 cm2
3
12.5 cm2
14.3 cm2
5.1 cm2
4
16 cm2
16.8 cm2
14 cm2
5
37.8 cm2
39.1 cm2
15.6 cm2
6
12.3 cm2
12.3 cm2
7.8 cm2
7
36 cm2
38.2 cm2
31.5 cm2
8
29.9 cm2
34 cm2
4 cm2
9
19.5 cm2
18.6 cm2
9 cm2
10
12.3 cm2
16 cm2
3.6 cm2
11
9.9 cm2
12 cm2
8.4 cm2
Total Average
19.1 cm2
21.6 cm2
11.9 cm2
2
VLU Patients
% size change after SOC
% size change after AM treatment
1
-3%
-40%
2
195%
-7%
3
114%
-64%
4
105%
-17%
5
103%
-60%
6
100%
-37%
7
106%
-17%
8
114%
-88%
9
-5%
-52%
10
130%
-77%
11
121%
-30%
Total Average
113%
-45%
DFU Patients
% size change after SOC
% size change after AM treatment
1
100%
-60%
2
Table 2
Table 5
VLU Patients
Measurement 1
Measurement 2
Measurement 3
1
36 cm2
36 cm2
14.4 cm2
2
12.3 cm2
12 cm2
6 cm2
3
21 cm2
23.4 cm2
8.6 cm2
2
-2%
-50%
111%
-63%
4
33.1 cm2
31.3 cm2
4 cm2
3
5
38 cm2
28.5 cm2
15 cm2
4
-5%
-88%
6
28 cm2
15 cm2
8.4 cm2
5
-25%
-47%
7
28.6 cm2
27.6 cm2
16.8 cm2
6
-46%
-44%
8
28 cm2
18 cm2
7.6 cm2
7
-3%
-39%
9
26.9 cm2
30 cm2
18 cm2
8
-36%
-58%
10
14 cm2
22.1 cm2
10.5 cm2
9
112%
-40%
11
18 cm2
18 cm2
1.3 cm2
10
158%
-52%
12
7.3 cm2
8.4 cm2
1.8 cm2
11
100%
-93%
Total Average
19.1 cm2
21.7 cm2
9.4 cm2
12
115%
79%
Total Average
-11%
-57%
Table 3
14
DFU + VLU
Measurement 1
Measurement 2
Measurement 3
Total Average
21.8 cm
21.6 cm
10.6 cm2
2
2
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Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane Figure 2: Amniotic product.
Table 6 DFU + VLU
% size change after SOC
% size change after AM treatment
Total Average
-1%
-51%
Table 7 Wound Type
N t score Two-tailed P-value
DFU
9 -3.63 0.0055
VLU
12 -4.66 0.0006
Total
21 -5.93 0.0001
Table 8 DFU Wound Area Measurements (cm2)
VLU Wound Area Measurements (cm2)
Patient
Initial size
After 5 weeks of SOC Treatment and Start of AM Treatment
5 weeks after AM & SOC Treatment
Patient
Prior to SOC Treatment
After 5 weeks of SOC Treatment and Start of AM Treatment
5 Weeks after AM & SOC Treatment
1
9
8.7
5.226
10
36
36
14.4
2
15
29.16
27
11
12.25
12
6
3
12.5
14.31
5.1
12
21
23.4
8.55
4
16
16.8
14.04
13
33.06
31.27
4
5
37.82
39.06
15.6
14
37.96
28.52
15
6
12.25
12.25
7.84
15
28
15
8.4
7
36
38.22
31.54
16
17.64
16.8
28.6
8
29.88
34
4
17
28
18
7.6
9
19.5
18.6
9
18
26.88
30
18
19
14
22.08
10.5
20
18
18
1.25
21
7.29
8.4
1.8
13.26
Mean
23.34
22.41
9.16
9.96
SD
9.81
8.43
Mean
20.88
23.46
SD
10.86
11.73
Total (N=23) Mean
22.29
The treatment protocol for AM application is to clean the wound bed and prepare the area for administration of the product. Debris was then removed, and curettage of the site was performed to ensure a clean and moist wound bed. AM was placed followed by a mesh and secured with steristrips. A secondary dressing was then applied to secure and maintain a balanced moisture environment for the wound bed. The procedure was repeated once weekly for the 5-week duration period. When collecting the data for this study, the initial measurements with SOC was recorded followed by 5 weeks of SOC treatment or the start of the AM treatment and then finally after 5 weeks of the subsequent AM treatment.
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22.41
5.44 10.92
Figure 3: Wound area measurement.
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Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane
“When we look at the matrix of AM as a material with the epithelial and mesenchymal cells that possess characteristics of pluripotent stem cells (a capability to differentiate into all three germ layers), there is a distinctive indication for its usage.”
Data Analysis After the data was collected for the three measurements, the ulcer healing process was accessed using a percentage of healed wound area for the measurable outcome. The comparison was between the percentage of healing when SOC was administered, and the difference after AM application. When reviewing the patients with diabetic foot ulcers, the average initial size of wound was 19.1 cm2. After the initial treatment with SOC, the findings indicated an increase in measurement on average to around 21.6 cm2. However, after the administration of AM, there was a substantial decrease in the average to 9.4 cm2. decrease in the average to 9.4 cm2. This indicated an overall reduction percentage of -45%, thus proving the effectiveness of AM treatment for this type of chronic wound. In the VLU patients, the initial average size of the wound was around 24.3 cm2. There was then a slight decrease to 21.6 cm2 after the treatment with SOC. This indicated a reduction percentage of -11%. AM treatment was then administered, and a significant reduction was seen again as the wounds measured – on average – 9.4 cm2. Another substantial decrease in the wound size of around-57% after treatment course.
Discussion In this study, the experts intentionally chose challenging wounds to evaluate the efficacy of AM treatment, as demonstrated in the inclusion/ exclusion criteria for those with DFU and those with VLU. In both clinical wound types, the patients responded to the SOC treatment at a refractory rate that showed minimal change, and in some instances the wound responded by increasing in size. This is a clear indication for considering new modalities for treatment as the efficacy of SOC cannot be reproduced, or continued with in most cases as that will result in further wound deterioration and potential
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risk factors presenting like inflammation or proliferation of the wound itself. However, comparatively once the patients received the AM treatment in combination with SOC there was a significant improvement and overall greater response that led to wound healing and a decrease in the total surface area of the wound; seen in both DFU and VLU patients. This substantial difference therefore supports the efficacy of the treatment. Another discussion around the usage of AM treatment proposed that it can be used as a skin substitute and reconstructive option for treating deeper dermal wounds and full thickness wounds.15 In this study, the purpose of the AM is to scaffold and provide a cell source that has the same histological and physiological components as the skin. Therefore, when we look at the matrix of AM as a material with the epithelial and mesenchymal cells that possess characteristics of pluripotent stem cells (a capability to differentiate into all three germ layers), there is a distinctive indication for its usage. The study approved and acknowledged the properties of AM and its likeness to skin as an enriched cell that contains a scaffolding structure that could be translated into clinical management.
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References 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6798798/#:~:text=Current%20 standard%20 of %20care%20(SOC,depending%20on%20wound%20location%20and 2. https://pubmed.ncbi.nlm.nih.gov/22592624/ 3. Dreifke, M. B., Jayasuriya, A. A., & Jayasuriya, A. C. (2015). Current wound healing procedures and potential care. In Materials Science and Engineering C (Vol. 48) https:// doi.org/10.1016/j.msec.2014.12.068 4. Elheneidy, H., Omran, E., Halwagy, A., Al-Inany, H., Al-Ansary, M., & Gad, A. (2016). Amniotic membrane can be a valid source for wound healing. International Journal of Women’s Health, 8. https://doi.org/10.2147/IJWH.S96636 5. Kogan, S., Sood, A., & Granick, M. S. (2018). Amniotic Membrane Adjuncts and Clinical Applications in Wound Healing: A Review of the Literature. In Wounds : a compendium of clinical research and practice (Vol. 30, Issue 6) 6. Schultz GS, Davidson JM 7. Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater 2015 Jul;103(5):1133-40. 8. Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. 9. Koob TJ, Lim JJ, Massee M, Zabek N, Denoziere G. Properties of dehydrated human amnion/ chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater. 2014 Aug;201(6):1353-62.
10. Koob TJ, Lim JJ, Massee M Zabek N, Rennert R, Gurtner G, Li WW. Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1;6:10. 11. Wu Qianqian et al. Comparison of the proliferation, migration and angiogenic properties of human amniotic epithelial and mesenchymal stem cells and their effects on endothelial cells. Int J Molecular Med Feb-2017 Vol 39 Issue 4 918-26. 12. Maan ZN, Rennert RC, Koob TJ, Januszyk M, Li WW, Gurtner GC, Cell recruitment by amnion chorion grafts promotes neovascularization. J Surg Res. 2015 Feb;193(2):953-62. 13. Massee M, Chinn K, Lim JJ, Godwin L, Young CS, Koob TJ. Type I and II Diabetic Adipose-Derived Stem Cells Respond In Vitro to Dehydrated Human Amnion/Chorion Membrane Allograft Treatment by Increasing Proliferation, Migration, and Altering Cytokine Secretion. Adv Wound Care (New Rochelle). 2016 Feb 1;5(2):43-54. 14. Irakoze L, et al. Efficacy and time sensitivity of amniotic membrane treatment in patients with diabetic foot ulcers: a systematic review and meta-analysis. Diabetes Therapy. 2017;8(5):967-79 15. Farhadihosseinabadi B, Farahani M, Tayebi T, Jafari A, Biniazan F, Modaresifar K, Moravvej H, Bahrami S, Redl H, Tayebi L, Niknejad H. Amniotic membrane and its epithelial and mesenchymal stem cells as an appropriate source for skin tissue engineering and regenerative medicine. Artif Cells Nanomed Biotechnol. 2018;46(sup2):431-440. doi: 10.1080/21691401.2018.1458730. Epub 2018 Apr 24. PMID: 29687742.
Alyssa Flores | President & CEO / CSQ Bio A trusted partner in the regenerative medicine and biologics industry With a team of distributors & agents throughout the United States, and soon to be international, Alyssa launched CSQ Bio™ in 2017 with the goal of bringing life changing products, therapies, and education to providers and medical experts at national hospitals, surgery centers, private practice facilities & mobile health care. Her passion is sourcing high quality, innovative products by building solid distribution channels to provide regenerative medicine & biologics to patients who are in need of wound care / wound healing. Today, CSQ Bio represents some of the best technology in the world. Soon to launch not only in the USA, but in Europe, Asia and Canada, it is a very unique autologous skin graft that will promote chronic wound healing utilizing the patient's own cells, delivered to the patient on the spot. To learn more, please contact Alyssa Flores | alyssa@csqbio.com | 602-769-1017 | WhatsApp
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Masterclass GUIDES Introduction This Masterclass guide is a concise overview aimed at exploring the use of SomaGen® and how to incorporate this into your practice.
What Is SomaGen®?
Allograft Dermal Matrix SomaGen® Keywords
■ Allograft ■ Venous leg ulceration ■ Diabetic foot ulcers
■ Ulcers ■ Wound healing
Figure 1: Different sizes of SomaGen®
■ SomaGen® Meshed supports treatment for large and complex wounds
■ The lattice-based slit design allows the graft to conform and expand based on the wound size and topography
■ Acellular human reticular dermal allograft ■ Eliminates autologous skin grafting need ■ Compatible with other common advanced wound modalities ■ Large slits ensure wound fluid egress while allowing the
How Does SomaGen® Work ? 1.
Prepare the graft: To prepare SomaGen® Meshed, first, remove the non-sterile outer pouch by peeling from the chevron seal side, then present the sterile inner pouch to the practitioner within the sterile field. Peel the inner pouch from the chevron seal side, and using sterile forceps, grasp the SomaGen® Meshed. Rinse the SomaGen® Meshed by submerging it in sterile saline or another isotonic solution.
2.
Prepare the Wound: Debride wound as necessary to ensure edges and base contain viable tissue prior to placement of SomaGen Meshed.
3.
Place Graft on Wound: Grafts are provided in four different size options that can expand to accommodate a variety of wound sizes. Apply graft on wound in a single layer ensuring no folds. Ensure maximal wound bed contact and tension-free fixation.
4.
Secure the Graft: Anchor graft with sutures (4a), staples (4b), or other suitable alternative. Anchor points should be approximately 1cm apart. Additional sutures on graft may be added to maintain full contact with wound surface. Any tears can be repaired via suturing.
5.
Apply Standard Dressings: Apply a permeable non-adherent dressing directly on top of graft. Ensure dressing prevents shearing forces and maintains contact between graft and wound.
patient’s own cells to rebuild tissue
■ Meshed pattern allows the graft to stretch significantly from its original size, providing flexibility and conformity to the needs of the wound
Figure 2: SomaGen® Meshed
■
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NOTE: When graft is used with Negative Pressure Wound Therapy (NPWT), a permeable non-adherent dressing may be an option, at the discretion of the clinician. NPWT dressings may be applied. If without NPWT, apply appropriate secondary dressings to maintain a moist wound healing environment.
Masterclass GUIDES
Allograft Dermal Matrix SomaGen® What Types of Wounds Are Suitable?
What Types of Wounds Are Not Suitable?
■
Replacement of damaged or inadequate integumental tissue
Local or systemic infection
■ ■ ■
Diabetic foot ulcers
■ ■ ■ ■ ■ ■ ■ ■ ■
Inability to cooperate with and/or comprehend post-operative instructions, and infected or nonvascular surgical sites
Venous leg ulcers Pressure ulcers or for other homologous use
Inflammatory response of non-infectious cause Uncontrolled diabetes Low vascularity of the surrounding tissue Mechanical trauma Pregnancy Poor nutrition or poor general medical condition Dehiscence and/or necrosis due to poor revascularization
Warnings and Cautions
■ ■ ■ ■ ■ ■
Do not sterilize Do not freeze No known sensitizing agents are present in this tissue SomaGen® Meshed is packaged in an ethanol solution and must be rinsed in a sterile solution prior to implantation Care should be taken when using SomaGen® Meshed in conjunction with electrical equipment NOTE: No antibiotics were used during the processing of this tissue.Extensive medical screening procedures have been used in the selection of all tissue donors for MTF (please see Donor Screening and Testing). Transmission of infectious diseases may occur despite careful donor selection and Laboratory testing, including serology and nucleic acid testing (NAT)
Figure 3: SomaGen® Meshed
Figure 4: SomaGen® Meshed packaging
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Masterclass GUIDES
Allograft Dermal Matrix SomaGen®
What Is the Evidence? The crossover study showed a high healing rate (83%) among patients who received the HR-ADM with SOC who had failed to heal with SOC alone in the RCT. The mechanism by which the reticular dermis stimulates healing has yet to be fully investigated. However, with the results showing such marked success of the HR-ADM application, this novel approach may provide a cost-effective technology to treat patients with difficultto-heal DFUs.1
Efficacy
■ Aseptically processed pre-
meshed HR-ADMs have an open architecture which allowed human fibroblasts and endothelial cells to readily attach and proliferate. The cells were able to secrete new ECM proteins that support granulation activities. Render series imaging showed that the cells infiltrated through the dermis over time. Furthermore, day 14 data showed cells bridging between meshed gaps. This type of infiltration and integration can support surgical wound closure. In addition, the secretion of angiogenic growth factors by the cells can help facilitate revascularization in a surgical wound environment2
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Pain
■ Possible adverse effects of using ADM include but are not limited to: local or systemic infection, dehiscence and/ or necrosis due to poor revascularization and a specific or nonspecific immune response to the graft
Debridement
■ SomaGen® Meshed, and its
biocompatible design, provides immediate wound coverage without the need for autologous skin grafting, lowering costs & saving time - all without compromising patient outcomes
Masterclass GUIDES
Allograft Dermal Matrix SomaGen® Key Points
■ SomaGen® Meshed: Features biocompatible design ■ Immediate wound coverage: No autologous skin grafting needed ■ Advantages: Reduces costs and saves time ■ Patient outcomes: Maintained without compromise References 1. Phipps, A., Vaynshteyn, E., Kowalski, J. B., Ngo, M. D., Merritt, K., Osborne, J., & Chnari, E. (2017, August 10). Chemical sterilization of allograft dermal tissues. Cell and Tissue Banking, 18(4), 573–584. https://doi.org/10.1007/s10561-0179647-0 2. Zelen, C. M., Orgill, D. P., Serena, T. E., Galiano, R. E., Carter, M. J., DiDomenico, L. A., Keller, J., Kaufman, J. P., & Li, W. W. (2018, April 22). An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial. International Wound Journal, 15(5), 731–739. https://doi.org/10.1111/iwj.12920
Useful Links
Use your device to scan this QR code for more information about SomaGen®
Visit the MTF Biologics website mtfbiologics.org
How to Cite this Article Masterclass Guide: Allograft Dermal Matrix: SomaGen® Wound Masterclass. Volume 2. No 6. December 2023
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Wound Masterclass - Vol 2 - December 2023
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Evolution of Dressing Change Frequency for Patients with Wounds Editorial Summary Wound dressing change frequency is a critical aspect of wound management. Historically, it relied on empirical observations, but evidence-based practices have evolved with advancements in wound care. Factors like wound type, depth, exudate levels, infection risk, and patient health influence dressing change frequency. Current best practices emphasize personalized care, regular assessments, advanced dressings, and patient education. Adopting evidence-based guidelines can optimize dressing change frequency and improve patient outcomes in wound healing.
Introduction
T
he management of wounds has evolved significantly over the years, and one crucial aspect is the frequency of dressing changes. Dressing change frequency plays a vital role in wound healing, as it directly impacts the patient’s comfort, wound infection rates, and overall healing process. In this article, we will explore the historical progression and the current best practices in dressing change frequency for patients with wounds.
Historical Background In the past, dressing change frequency was largely based on empirical observations, and there was a lack of scientific evidence to support specific intervals. Dressings were often changed daily or even multiple times a day, under the belief that frequent changes would promote wound healing. However, it was later realized that this practice might lead to unnecessary disturbance of the wound bed, causing additional trauma and potentially hindering the healing process.
Advancements in Wound Care
Dr Negin Shamsian Consultant Plastic & Reconstructive Surgeon (Locum) Chief Editor of Wound Masterclass
22
With advancements in wound care research and technology, a shift occurred towards evidencebased practices. The concept of ‘moist wound healing' gained popularity, which advocates maintaining a moist environment around the wound to facilitate cellular activities and minimize tissue damage. This shift led to the recognition that dressing change frequency should be adjusted based on the wound characteristics and healing trajectory.
Wound Masterclass - Vol 2 - December 2023
Factors Influencing Dressing Change Frequency Several factors influence the dressing change frequency for patients with wounds: Wound Type and Depth Different wound types, such as acute, chronic, surgical, or traumatic, require varying approaches to dressing changes. The depth of the wound also affects the frequency, with deeper wounds generally requiring less frequent changes to prevent disruption of the delicate healing processes. Exudate Levels The amount of wound exudate, or drainage, is a crucial factor in determining dressing change frequency. Highly exuding wounds may necessitate more frequent changes to avoid saturation and maintain a moist environment. Infection Risk Infected wounds often require more frequent dressing changes to manage the bacterial load and prevent complications. Dressing change frequency may decrease as the infection resolves. Patient Factors The overall health and individual patient needs, such as age, comorbidities, and mobility, influence the dressing change frequency. Patients with compromised immune systems or impaired healing may require more frequent
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Evolution of Dressing Change Frequency for Patients with Wounds
“By carefully assessing wound characteristics and individual patient needs, healthcare providers can optimize dressing change frequency and contribute to improved patient comfort and better healing results.”
changes.
Utilizing Advanced Dressings
Best Practices in Dressing Change Frequency
Modern wound care has introduced a wide range of advanced dressings that can stay in place for more extended periods, reducing the need for frequent changes. These dressings provide an optimal moist wound healing environment and help to promote faster healing.
Currently, evidence-based guidelines recommend a more personalized approach to dressing change frequency. The focus is on optimizing wound healing while minimizing unnecessary interventions. Some best practices include: Assessment and Reassessment Regular and thorough wound assessments are essential to determine the appropriate dressing change frequency. Reassessment should occur whenever there are changes in wound characteristics or the patient’s condition. Individualized Care Tailoring the dressing change frequency to each patient’s specific needs is crucial. Consideration should be given to wound type, exudate levels, infection status, and the patient’s overall health.
Patient Education Engaging patients in their wound care and providing proper education on signs of infection, dressing maintenance, and when to seek medical attention empowers patients to take an active role in their healing process.
Conclusion The evolution of dressing change frequency for patients with wounds reflects a shift towards evidence-based practices and a more personalized approach to wound care. As healthcare professionals, it is essential to stay updated with the latest research and guidelines to provide optimal wound healing outcomes for patients. By carefully assessing wound characteristics and individual patient needs, healthcare providers can optimize dressing change frequency and contribute to improved patient comfort and better healing results.
References 1. Winter GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962;193(4812):293-294. 2. Thomas S. The role of dressings in wound infection. Prof Nurse. 1999;15(4):227-231. 3. Schultz GS, Sibbald RG, Falanga V, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003;11 Suppl 1:S1-S28. 4. Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles. 4th ed. Lippincott Williams & Wilkins; 2012. 5. Romanelli M, Dini V, Bertone MS, et al. Randomized comparison of silver-coated dressing (Acticoat®) and chlorhexidine acetate 0.5% (Bactigrass®) in the topical treatment of partial thickness burns. Burns. 2005;31(7):875-881. 6. Moore Z, Cowman S. Conquering pressure ulcer pain: Evaluating the use of a soft silicone wound contact layer. Br J Nurs. 2012;21(13):S14, S16-S17. 7. Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC. State-of-the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg. 2006;44(5):1029-1037.
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8. White R. The role of occlusive dressings in the healing of split-skin graft donor sites. J Wound Care. 1998;7(10):503-507. 9. Waring MJ, Parsons D. Physico-chemical characterisation of carboxymethylated spun cellulose fibres. Biomaterials. 2001;22(9):903-912. 10. Cutting KF, White RJ. Maceration of the skin and wound bed 1: its nature and causes. J Wound Care. 2002;11(7):275-278. 11. Ovington LG. Hanging wet-to-dry dressings out to dry. Adv Skin Wound Care. 2002;15(2):79-86. 12. Wang JT, Chang SC, Ko WJ, Chang YS. Removal of adherent skin bacteria in the normal external auditory canal. Laryngoscope. 1999;109(4):597-601. 13. Beldon P. How safe are adhesive wound dressings in elderly care? J Wound Care. 2001;10(7):289-290. 14. Chaby G, Senet P, Vaneau M, et al. Dressings for acute and chronic wounds: a systematic review. Arch Dermatol. 2007;143(10):1297-1304. 15. International Skin Tear Advisory Panel. ISTAP Wound Consensus Update: Wound Bed Preparation in Practice. Wounds International; 2016.
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Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy? Editorial Summary High-quality evidence to guide treatment selection of chronic wounds remains lacking. The conventional parallel-arm randomized controlled trial (RCT) model for wound healing studies has limitations. Complete wound closure as a primary endpoint necessitates trials with large sample sizes and prolonged follow-up to achieve adequate statistical power. Such trials are logistically difficult to conduct and may fail to detect more modest treatment effects on wound healing kinetics. Novel metrics have been suggested such as percentage area reduction (PAR) over a 4-week period as a surrogate endpoint. The Food and Drug Administration (FDA) now recognizes PAR as a potential primary endpoint for registrational wound healing trials. PAR following a linear trajectory over time, allows more granular detection of changes in wound healing rate. The self-controlled study model leverages within-patient comparisons, thereby removing potential confounding from between-patient differences. A recent two-phase study of 60 patient with VLUs provides a salient example of this trial design. There was an initial 4-week run-in phase with standard compression therapy alone. Patients were then randomized to continue compression alone or add adjunctive neuromuscular electrical stimulation (NMES) for an additional 4 weeks. The addition of NMES significantly increased the PAR rate compared to compression alone in the same patient cohort (p=0.016). Meanwhile, the control group’s healing rate was unchanged between study phases. These findings demonstrate the feasibility of employing PAR and within-patient controls to efficiently discriminate treatment effects with a limited sample size over a 2-month study duration. The design of wound healing trials has been constrained by overreliance on complete wound closure in large cohorts. Metrics like PAR may provide higher quality evidence to improve wound care.
Novel Approaches in Chronic Wound Healing Research
C
hronic wounds, such as venous leg ulcers (VLUs), impose a substantial global disease burden, with costs exceeding $14 billion annually in the United States alone.1 Yet, there is a dearth of high-quality evidence supporting effective treatments. The conventional randomized controlled trial (RCT) model employed in wound healing research is fraught with significant limitations that impede the efficient assessment of new therapies. Relying on complete wound closure as the primary outcome necessitates protracted, large-scale trials that pose logistical challenges and frequently fail to detect treatment effects. Consequently, there have been calls to question this conventional wisdom by embracing alternative metrics and study designs better suited to evaluating healing rates over shorter timeframes.
Shortcomings of the Conventional RCT Model
Dr Keith Gordon Harding Welsh Wound Innovation Centre Pontyclun, United Kingdom
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The customary RCT protocol, which compares complete healing between groups, renders wound healing studies particularly arduous. The extreme heterogeneity of chronic wounds makes it challenging to match intervention and control groups. Furthermore, the binary nature of the complete healing outcome lacks statistical power compared to quantitative metrics. Thus, demonstrating significant differences between groups mandates following large patient cohorts over many months, leading to exorbitant costs, high dropout rates, and delayed results.
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A systematic review in 2016 identified only two interventions with significant evidence from RCTs - compression and pentoxifylline. Out of thousands of wound therapy studies, merely 48 RCTs met the criteria for quality, and only eight yielded stand-alone findings of effectiveness. This glaring scarcity of high-quality evidence primarily stems from the methodological challenges intrinsic to the conventional RCT design for wound healing. Firstly, the cohort comparison framework is unable to overcome inter-patient variations in wound chronicity, size, microbiome, comorbidities, adherence, and other confounding factors. Achieving matching intervention and control groups is unattainable given this heterogeneity. Secondly, complete healing is inherently a binary outcome - either achieved or not. Analyzing such binary data using frequency statistics lacks sensitivity compared to quantitative metrics capable of assessing the degree of change. Thirdly, the protracted follow-up required until a sufficient number of wounds achieve complete closure makes maintaining subject engagement and ensuring consistent assessment over months of treatment challenging.
Alternative Metrics and Study Designs In recent years, experts have proposed addressing these issues by embracing alternative primary endpoints and study models.
Continuous Metrics of Healing Rate Instead of focusing on final complete closure,
Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy?
“The primary outcome was PAR over each 4 week phase, rather than final complete closure. The addition of NMES significantly increased the PAR healing rate compared to compression alone for the same patients.”
assessing intermediate outcomes related to the healing rate could offer greater statistical power. Metrics such as wound area, volume, depth, or diameter changes over a fixed period can be analyzed as continuous variables to detect significant differences with fewer subjects and shorter durations. In 2020, the FDA suggested percentage area reduction (PAR) over 4 weeks as a potential primary endpoint for wound trials. PAR has been shown to follow a consistent linear trajectory during this timeframe, enabling the quantification of changes in the healing rate after introducing an intervention.
Self-Controlled Study Designs Rather than cohort comparisons, self-controlled models eliminate between-patient confounding by conducting within-patient comparisons. Each subject serves as their control. Variations include split-body comparisons, contralateral controls, or pre-post-treatment assessments of the same wound. The pre-post self-controlled approach compares the initial baseline healing rate over weeks with a subsequent treatment phase healing rate for the same wound. This allows the detection of differential effects of the new treatment while controlling for all stable patient factors. By removing confounders, self-controlled studies can identify significant differences with far fewer subjects and shorter durations.
Feasibility of New Approaches A VLU trial conducted in 2021 illustrated the potential of employing PAR and a pre-post selfcontrolled design to efficiently discern treatment effects. This trial compared compression alone versus the addition of neuromuscular electrical stimulation (NMES) for 60 patients over an 8 week period. The two-phase structure involved a 4 week control run-in period with compression alone to establish a baseline healing trajectory. Subsequently, patients were randomized to either continue with compression
alone or add NMES for another 4 weeks. By comparing each patient’s healing rate between phases, confounding variables were intrinsically controlled. The primary outcome was PAR over each 4 week phase, rather than final complete closure. The addition of NMES significantly increased the PAR healing rate compared to compression alone for the same patients. Meanwhile, the control group’s PAR rate remained unchanged between phases. This exemplifies how a smaller number of patients studied over a shorter duration can yield statistically significant results when using PAR and within-patient controls, as opposed to relying solely on complete healing cohorts.
New Approaches to Overcome Conventional RCT Limitations The implementation of alternative metrics and self-controlled designs can help address the principal limitations of the traditional RCT approach to wound healing research.
Overcoming Patient Heterogeneity
and
Wound
Self-controlled studies eliminate confounding by comparing outcomes for the same patient, thereby controlling for individual characteristics that may influence healing, such as age, comorbidities, nutritional status, microbiome, wound location, etc. Comparing the same wound over time also accounts for differences in chronicity, area, depth, tissue type, vascular supply, and other wound factors.
Enhancing Statistical Quantitative Metrics
Power
with
PAR provides a continuous variable metric that is amenable to sensitive parametric statistics. This enhances the ability to discern differential effects with smaller sample sizes compared to
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Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy?
“The wider adoption of these approaches necessitates addressing certain considerations related to blinding, validity, recruitment, and regulatory acceptance.”
binary complete healing outcomes. Assessing the degree of change, rather than solely focusing on whether healing is achieved or not, better reflects clinical reality where any acceleration of healing is considered beneficial.
Improving Logistical Shorter Trials
Feasibility
with
The 4 week PAR endpoint allows for trials as short as 8 weeks, as opposed to the months required for complete closures. Greater feasibility results from quicker enrollment, better subject retention over weeks rather than months, consistent wound assessment over a shorter period, and faster acquisition of results.
Additional Implementation Considerations The wider adoption of these approaches necessitates addressing certain considerations related to blinding, validity, recruitment, and regulatory acceptance. While blinding the intervention assignment may be challenging when patients can discern whether they are receiving electrical stimulation, it is still possible to blind wound assessments using standardized photography and assessors unaware of the treatment phase. Questions remain regarding the external validity and generalizability of results from self-controlled trials with limited patient populations. Nonetheless, patient cohorts should be sufficiently large to empower the detection of clinically meaningful differences in healing rates, and the inclusion of diverse wound chronicities and types would enhance generalizability. Efficient recruitment and retention are pivotal for feasibility. Stringent inclusion and exclusion criteria may minimize heterogeneity but could hinder recruitment. These criteria could be broadened to some extent, provided they do not significantly affect the magnitude of withinpatient confounding. While self-controlled designs conceptually require perfect protocol
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adherence and subject retention, modern statistical methods allow for intention-to-treat analysis approaches with these designs. Finally, regulatory acceptance of PAR and selfcontrolled trials would facilitate implementation. The FDA’s recent draft guidance endorses PAR over 4 weeks as a potential primary endpoint. Self-controlled methods are also suitable for evaluating medical devices, as long as patients serve as their own controls.
Conclusion In conclusion, designing wound healing studies using PAR over fixed intervals as the primary outcome and analyzing them within a selfcontrolled model offers significant advantages over traditional complete healing RCTs. This approach finally furnishes the methodology necessary to efficiently generate rigorous evidence on interventions to address the substantial unmet needs of chronic wound patients. Given the immense disease burden, advancing wound care necessitates questioning conventional research practices and embracing more innovative and feasible trial designs. The success of recent trials, such as the NMES study, underscores the promise of new metrics and models. Wider adoption would expedite the acquisition of definitive evidence to enhance care and outcomes for the millions suffering from chronic wounds worldwide.
References 1. Rice JB, Desai U, Cummings AK, et al. Burden of venous leg ulcers in the United States. J Med Econom 2014;17(5):347–356. 2. Neumann HAM, Cornu-Thenard A, Junger M, et al. Evidence-based (S3) guidelines for diagnostics and treatment of venous leg ulcers. J Eur Acad Dermatol Venereol 2016;30:1843– 1875. 3. Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid 2016;2016:1902. 4. Godwin M, Ruhland L, Casson I, et al. Pragmatic controlled clinical trials in primary care: The struggle between external and internal validity. BMC Med Res Methodol 2003;3:28; doi: 10.1186/ 1471-2288-3-28 5. Eckert KA, Carter MJ. Assessing the uncertainty of treatment outcomes in a previous systematic review of venous leg ulcer randomized controlled trials: Additional secondary analysis. Wound Repair Regen 2021;29(2):327–334. 6. Robson MC, Hill DP, Woodske ME, et al. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg 2000;135:773– 777. 7. Fife CE, Eckert KA, Carter MJ. Publicly reported wound healing rates: The fantasy and the reality. Adv Wound Care (New Rochelle) 2018;7(3):77–94; doi: 10.1089/wound.2017.0743 8. Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol 2002;119(6):1420–1425; doi: 10.1046/j.1523-1747.2002 9. Polansky M, Van Rijswijk L. Utilizing survival analysis techniques in chronic wound healing studies. Wounds 1994;6:150–158. 10. Gault N, Castan˜eda-Sanabria J, De Rycke Y, et al. Self-controlled designs in pharmacoepidemiology involving electronic healthcare databases: A systematic review. BMC
Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy? Med Res Methodol 17: 25(2017); doi: 10.1186/s12874-016-0278-0 11. FDA Wound Healing Clinical Focus Group. Guidance for industry: Chronic cutaneous ulcer and burn wounds-developing products for treatment. Wound Repair Regen 2001;9(4):258–268. 12. Verma KD, Lewis F, Mejia M. Food and Drug Administration perspective: Advancing product development for nonhealing chronic wounds. Wound Repair Regen 2022;30(3):299–302. 13. Driver VR, Gould LJ, Dotson P, et al. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community. Wound Repair Regen 2017;25(3): 454–465; doi: 10.1111/wrr.12533 14. Driver VR, Gould LJ, Dotson P, et al. Evidence supporting wound care end points relevant to clinical practice and patients’ lives. Part 2. Literature survey. Wound Repair Regen 2019;27(1): 80–89. 15. Bull RH, Staines KL, Collarte AJ, et al. Measuring progress to healing: A challenge and an opportunity. Int Wound J 2022;19(4):734–740. 16. Aleksandrowicz H, Owczarczyk-Saczonek A, Placek W. Venous leg ulcers: Advanced therapies and new technologies. Biomedicines 2021;9(11): 1569. 17. Bull RH, Clements D, Collarte AJ, et al. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J 2023 [Epub ahead of print]; doi: 10.1111/iwj .14107 18. Tucker A, Maass A, Bain D, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol 2010;19(1):e31– e37. 19. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMC Med 2010; 8:18; doi: 10.1186/1741-7015-8-18 20. Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: A review of trials funded by two UK funding agencies. Trials 2013;14:166. 21. O’Meara S, Cullum N, Nelson EA, et al. Compression for venous leg ulcers. Cochrane Database Syst Rev 2012;11(11):CD000265; doi: 10.1002/14651858.CD000265.pub3 22. Eaglstein WH, Kirsner RS, Robson MC. Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies. Wound Repair Regen 2012;20(6):793–796. 23. Maderal AD, Vivas AC, Eaglstein WH, et al. The FDA and designing clinical trials for chronic cutaneous ulcers. Semin Cell Dev Biol 2012;23(9): 993–999. 24. Darwin E, Tomic-Canic M. Healing chronic wounds: Current challenges and potential solutions. Curr Dermatol Rep 2018;7(4):296– 302; doi: 10.1007/s13671-018-0239-4.
25. Va˚gesjo¨ E, Grigoleit P, Fasth A, et al. How can we optimize the development of drugs for wound healing? Expert Opin Drug Discov 2022;17(2): 93–96. 26. Gagne JJ, Fireman B, Ryan PB, et al. Design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf 2012;21(Suppl. 1):32–40. 27. Lehr AM, Jacobs WC, Stellato RK, et al. Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery. Clin Trials 2022;19(3):259–266. 28. Birmingham TB, Marriott KA, Leitch KM, et al. Association between knee load and pain: Withinpatient, between-knees, case-control study in patients with knee osteoarthritis. Arthritis Care Res (Hoboken) 2019;71(5):647–650. 29. Melandri D, De Angelis A, Orioli R, et al. Use of a new hemicellulose dressing (Veloderm) for the treatment of splitthickness skin graft donor sites A within-patient controlled study. Burns 2006; 32(8):964–972. 30. Leshem YA, Wong A, McClanahan D, et al. The effects of common over-the-counter moisturizers on skin barrier function: A randomized, observerblind, within-patient, controlled study. Dermatitis 2020;31(5):309–315. 31. Zhang M, Sun J, Zhu M, et al. Within-patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers. Int Wound J 2022; doi: 10.1111/ iwj.14051 32. Wan F. Statistical analysis of two arm randomized pre-post designs with one post-treatment measurement. BMC Med Res Methodol 2021;21(1):150. 33. Gibelli G, Negrini M, Bruno AM, et al. Chronic effects of transdermal nitroglycerin in stable 8 BULL ET AL. angina pectoris: A within-patient, placebocontrolled study. Int J Clin Pharmacol Ther Toxicol 1989;27(9):436–441. 34. Martı´nez-Jime´nez EM, Losa-Iglesias ME, Antolı´nGil MS, et al. Flexor digitorum brevis muscle dry needling changes surface and plantar pressures: A pre-post study. Life (Basel) 2021;11(1):48. 35. Jime´nez-Garcı´a JF, Aguilera-Manrique G, ArboledasBello´n J, et al. The effectiveness of advanced practice nurses with respect to complex chronic wounds in the management of venous ulcers. Int J Environ Res Public Health 2019;16(24):5037. 36. Gault N, Castan˜eda-Sanabria J, Guillo S, et al. Underuse of self-controlled designs in pharmacoepidemiology in electronic healthcare databases: A systematic review. Pharmacoepidemiol Drug Saf 2016;25(4):372–377. 37. Dolibog P, Franek A, Taradaj J, et al. A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. Int J Med Sci 2013;11(1):34–43; doi:10.7150/ijms.7548 38. Sealed Envelope Ltd. Power calculator for binary outcome superiority trial. [Online]. 2012. Available from: https://www. sealedenvelope.com/power/ binary-superiority/ [Last accessed: August 21, 2023]. 39. Lucas Y, Niri R, Treuillet S, et al. Wound size imaging: Ready for smart assessment and monitoring. Adv Wound Care (New Rochelle) 2021;10(11):641–661.
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Introducing Wound Masterclass Video
woundmasterclass.com/Video
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Wound Cleaning Products:
Masterclass GUIDES Introduction This Masterclass Guide is a concise overview aimed at exploring the use of Prontosan®. Prontosan® offers a specialized wound care solution comprising a cleansing solution and wound gel. Consider incorporating Prontosan® into your practice guided by individual patient needs and wound characteristics.
What Is Prontosan®?
Prontosan®
Keywords ■ Prontosan ■ Wound Care ■ Prontosan® Solution ■ Prontosan Wound Gel ■ Polyhexanide (PHMB) ®
®
■ Wound Healing ■ Wound Management ■ Ulcers ■ Burns ■ Surgical Wounds
Figure 1:
■ Prontosan® is a comprehensive wound care solution consisting of a cleansing solution and a wound gel, formulated to assist in the management and healing of various types of wounds
■ It comprises two key components: Prontosan® Solution and
Prontosan® Wound Gel. The solution is used for wound irrigation and cleansing, while the gel is applied directly to the wound bed
■ It contains polyhexanide (PHMB), an effective antimicrobial agent
that combats a broad range of microorganisms, including bacteria and fungi. It also contains betaine, which contributes to maintaining a balanced moisture level on the wound’s surface
■ It is designed to promote wound healing by creating an
How Prontosan® Works? The Ten Step Guide
environment conducive to tissue regeneration, granulation, and angiogenesis (formation of new blood vessels)
1.
Select the appropriate patient.
■ The antimicrobial action of PHMB in Prontosan® helps prevent and
2.
Examine the wound to determine its size, depth, and condition. Note any signs of infection, inflammation, or other abnormalities.
■ It helps maintain a moist wound environment, which has been
3.
Cleanse the wound using an appropriate wound cleanser or sterile saline solution. Gently remove debris, excess exudate, and any foreign particles.
■ Prontosan® Wound Gel aids in the removal of necrotic (dead) tissue
4.
Gently pat the wound area dry using sterile gauze. Avoid excessive rubbing, as it could damage delicate tissue.
■ It is suitable for various wound types, including surgical wounds,
5.
Squeeze a small amount of Prontosan® Wound Gel onto a clean, sterile surface. Use a sterile applicator or clean gloves to pick up the gel.
■ The presence of a moist gel on the wound can offer pain relief,
6.
Apply a thin and even layer of the gel directly to the wound bed. Ensure complete coverage, especially in deeper wounds.
■ The products are typically easy to apply and integrate into wound
7.
Gently spread the gel over the wound using a sterile applicator or clean, gloved finger. Avoid applying excessive pressure that could disrupt healing tissue.
8.
Place an appropriate wound dressing over the gel to protect the wound and maintain its moist environment. Ensure the dressing covers the entire wound area and is securely in place.
9.
Record the date, time, and details of the wound care procedure in the patient’s medical records. Include information about the type of dressing used and any observations made during the process.
control infections in wounds, reducing the risk of complications that can hinder the healing process shown to accelerate healing by supporting cell migration and minimizing tissue desiccation
from the wound bed, promoting the growth of healthy tissue and assisting in wound debridement
ulcers (such as diabetic and pressure ulcers), burns, and donor sites used for skin grafts particularly in wounds with exposed nerve endings
care routines, following the guidelines provided by healthcare professionals used for skin grafts
10. Patient Follow-Up: Schedule regular follow-up appointments to assess the progress of wound healing and adjust the treatment plan as necessary.
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Wound Masterclass - Vol 2 - December 2023
Wound Cleaning Products:
Masterclass GUIDES
Prontosan®
What Types of Wounds Are Suitable?
What Types of Wounds Are Not Suitable?
■ Surgical wounds ■ Chronic wounds ■ Pressure ulcers ■ Minor abrasions and cuts
■ Allergies ■ Sensitive Mucous Membranes ■ Internal Use ■ Severe Burns ■ Implanted Devices
■ Traumatic wounds ■ Burns ■ Venous ulcers ■ Wounds with delayed healing
■ ■ ■ ■
Underlying Medical Conditions Pregnancy and Breastfeeding Immunocompromised Individuals Underlying Skin Conditions
Adverse Effects: Chronic use may cause irritation.
Figure 2: Prontosan® wound gel
Figure 3: Prontosan® wound gel application
Figure 4: Prontosan® wound solution
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Wound Cleaning Products:
Masterclass GUIDES
Prontosan®
What Is the Evidence? Clinical studies and research papers have explored various aspects of the usage of Prontosan®, including its impact on wound healing, infection prevention, pain relief, and overall wound management. These studies often involve both Prontosan® Solution and Prontosan® Wound Gel.
Efficacy
■ Wound Cleansing: Prontosan®
Solution is effective for wound irrigation and cleansing, removing debris and contaminants. It can help create a clean wound bed, which is essential for optimal healing
■ Infection Prevention: The
antimicrobial properties of Prontosan®, particularly polyhexanide (PHMB), contribute to preventing and controlling wound infections. By reducing microbial load, it supports a healthier wound environment
■ Moist Wound Healing: Prontosan®
products help maintain a moist wound environment, which is known to facilitate wound healing processes such as cell migration, angiogenesis, and granulation tissue formation
■ Debridement: Prontosan® Wound
Infection
■ The antimicrobial properties
of Prontosan®, particularly polyhexanide (PHMB), contribute to preventing and controlling wound infections. By reducing microbial load, it supports a healthier wound environment
■ For wounds that are already
infected, the antimicrobial properties of Prontosan® can help control and manage the infection. By reducing the number of microorganisms, it supports the body’s natural defense mechanisms and provides a healthier environment for healing
Costs
■ Prontosan® solution 40ml ampoule costs around £15 for the box of 24
■ Prontosan® gel 50g tube costs around £12
■ From the date of opening, the solution and gel can be used up to 8 weeks for single patient use
■ Long shelf life at ambient temperature storage (3 years after date of manufacture)
■ Prontosan® can also be used
preventively in wounds at risk of infection, such as surgical wounds or wounds with compromised immune function. It helps reduce the likelihood of infection development
Gel’s debridement properties aid in the removal of necrotic tissue, allowing for the growth of healthy tissue and promoting wound healing
■ Pain Relief: The presence of the
moist gel on the wound can provide pain relief, particularly in wounds with exposed nerve endings
Prontosan has tested efficacy on multiple species of bacteria within 60 seconds, this means Prontosan is suitable for irrigation in wounds where only planktonic bacteria is a concern. For wounds suspected of containing biofilm, irrigation with Prontosan is shown to be more effective than other cleansers over 3 – 6 day periods, however for maximum benefit in wounds where biofilm is a possibility, an enhanced contact time is recommended. The betaine within Prontosan provides the surfactant / cleansing effect for biofilm disruption and cleansing of slough and PHMB is present as an adjuvant ingredient.
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Wound Cleaning Products: Prontosan®
Masterclass GUIDES
Key Points ■ It is a comprehensive wound care solution that includes solution for cleansing and wound gel for direct wound application ■ It contains polyhexanide (PHMB), an antimicrobial agent effective against a range of microorganisms, supporting infection prevention and control
■ It maintains a moist wound environment, promoting tissue regeneration, granulation, and angiogenesis, key processes in wound healing ■ Prontosan Wound Gel aids in debridement by removing necrotic tissue, while its moist presence on wounds can offer pain relief ■ It is suitable for various wound types, including surgical wounds, ulcers, burns, and donor sites, providing adaptable wound care ■ It’s antimicrobial properties help prevent wound infections by reducing microbial load and disrupting biofilm formation
There is no limit set for the treatment duration with Prontosan® Wound Irrigation Solution. In clinical trials, the longest documented treatment duration was 6 months. In fact, Prontosan® is especially designed for the long term treatment of hard-to-heal wounds. Prontosan Wound Gel and Wound Gel X should be cleansed off at every dressing change, continual contact should not exceed 30 days, most likely dressing changes occur more regularly than this and usually within 7 days.
References 1. 2. 3. 4.
Prontosan® Wound Gel [Internet]. www.bbraun.com. Available from: https://www.bbraun.com/en/products/b/prontosan-wound-gel.html Prontosan® Wound Irrigation Solution [Internet]. www.bbraun.com. Available from: https://www.bbraun.com/en/products/b/prontosan-wound-irrigation-solution-for-wounds-and-burns.html Guidance: Prontosan Solution and Gel X [Internet]. Available from: https://www.bsuh.nhs.uk/library/wp-content/uploads/sites/8/2020/08/Prontosan-Application-Brighton-and-Sussex-Final.pdf Prontosan (betaine-polyhexanide) dosing, indications, interactions, adverse effects, and more [Internet]. reference.medscape.com. Available from: https://reference.medscape.com/drug/prontosan-betaine-polyhexanide-999621
Useful Links
Use your device to scan this QR code for more information about Prontosan® wound cleaning products
Visit the B Braun website: bbraun.com
How to Cite this Article Masterclass Guide: Wound Cleaning Products: Prontosan® Wound Masterclass. Volume 2. No 6. December 2023
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Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings? Editorial Summary Diabetic Foot Ulcers (DFUs) are a significant challenge to wound care clinicians1 and place a financial burden on healthcare systems globally. Annually DFUs cost the USA hundreds of billions and the UK up to £1 billion annually.1 Early referral of patients with DFUs to a specialist service improves outcomes. TLCNOSF Technology (Technology Lipido-Colloid - Nano Oligo Saccharide Factor) has a strong evidence base supporting its usage including several randomised controlled trials and some real world evidence . The purpose of this article is to explore the real world evidence of using UrgoStart dressings as first-line local treatment and part of the standard of care for the management of patients with a DFU2,3,16
Introduction
E
surgical debridement, offloading and optimising the wound condition. Standard care includes metabolic control, pressure relief (offloading), vascular assessment and control of ischaemia, wound debridement, wound dressings, and infection control measures.6-7
Background
UrgoStart dressings are recommended for the treatment of DFUs as they are associated with increased closure rate, shorter time-to-closure, and cost savings.8 They are a range of dressings with Technology Lipido-Colloid – Nano Oligo Saccharide Factor (TLC-NOSF) technology, which is a lipido-colloid healing matrix impregnated with sucrose octasulfate.2 Matrix Metalloproteinases (MMPs) may be present and play a pivotal role in both acute and chronic wounds. They regulate extracellular matrix degradation and deposition that is essential for wound reepithelialization.
vidence exists to support the recommendation for the use of UrgoStart dressings as part of standard care for the treatment of diabetic foot ulcers (DFUs). This study, evaluating routine use for DFU patients in the UK, confirmed that early intervention with evidence based local wound treatment use leads to healing in most patients, with a mean time to healing of 24 days. In 2023, NICE renewed it’s support of the UrgoStart treatment leading to increased wound healing. Those who benefit most are those with less severe DFUs. DFUs remain a frequent and serious complication of diabetes mellitus, resulting in a variety of adverse effects for the patient and high economic cost.
Ms Michelle Goodeve Diabetes Specialist Podiatrist Chelmsford, United Kingdom
Ms Laura Saunders Podiatrist, Wound Care Specialist Essex, United Kingdom
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DFUs are a frequent and serious complication of diabetes mellitus, characterised by a high risk of infection and amputation, impaired patient quality of life, and substantial financial burden.2 This is evident in the provided Community Interest Company (CIC) caseload which is only commissioned for high risk patients which in reality means most of the appointments available are for patients with current foot ulceration. They may result in sleep disturbance, depression and anxiety; pain and discomfort, associated with exudate leakage or malodour; restricted mobility, difficulty with daily activities and limited leisure activities.4-5 The main goal of DFU treatment is to have ulcer free days and reduce the risk of serious complications. This requires a multidisciplinary approach like vascular intervention, surgery,
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The delayed healing of chronic wounds such as DFUs, leg ulcers or pressure ulcers has been associated with an excess of matrix metalloproteinases (MMPs), present since the onset of the wounds.9 The TLC-NOSF healing matrix interacts with the wound microenvironment by limiting the deleterious action of (MMPs), which in excess leads to continuous degradation of the extracellular matrix components.
What Was the Aim of the Study? The study aimed to evaluate the clinical outcomes for patients being treated with the UrgoStart treatment range on first intervention along with the other appropriate standards of care after implementing the UrgoStart range for
Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?
"UrgoStart is a range of dressings which can improve wound healing for diabetic foot ulcers and improve the rate of wound healing for venous leg ulcers. Cost modelling shows that UrgoStart is cost saving compared with standard care dressings in these groups. UrgoStart should therefore be considered as an option for people with diabetic foot ulcers or venous leg ulcers after any modifiable factors such as infection have been treated.”
DFU patients. Figure 2: Data collection pathway.
Methods
Data Collection Pathway
The study was a prospective, observational, single-arm study in the UK, enrolling patients over an 8 week period and following them up for a maximum of 20 weeks. UrgoStart contact and UrgoStart Plus Pad, which benefit from TLC-NOSF technology, were evaluated. UrgoStart Contact is a flexible wound contact layer dressing made of a polyester textile mesh coated with the TLCNOSF healing matrix, intended for use on wounds mainly covered with granulation tissue; while UrgoStart Plus Pad, a non-woven pad made of cohesive polyabsorbent fibres coated with a soft adherent TLC-NOSF healing matrix, is intended for use on exudative wounds, regardless of their level of sloughy tissue. Patients were seen at the community podiatry clinic on a weekly basis for reassessment, treatment, and data capture. In the case of shared care, dressing changes were performed between clinic visits by the community nurses, the patients, or their relatives. Patients’ and wound-related characteristics were documented in a standardised case report form at baseline and every 2 weeks until wound closure, patient withdrawal from the study, or the completion of the 20-week follow-up, whichever occurred first. The following data was recorded:
■ ■ ■ ■ ■
■
Full mental capacity, and ability to give written informed consent to participate in the study
Critical limb ischaemia
Other medical history, such as amputation history, ulceration history; renal deficiency, cardiovascular disease; patient mobility, and metabolic control, with glycated haemoglobin test Patient’s health-related quality of life (HRQoL), measured with the EuroQol-visual analogue scale (EQ-VAS) Wound characteristics, such as wound duration reported in weeks; wound location (‘sole of the foot’, ‘tip of the toe’, ‘side of the foot’, ‘dorsum of the foot’, ‘other’); severity score using the SINBAD scale
Wound characteristics, including wound area and depth, wound bed tissue (percentage of necrotic, sloughy and granulation tissues); exudate levels (‘none’, ‘low’, ‘moderate’, ‘high’), and surrounding skin condition (‘healthy’, ‘dry’, ‘erythematous’, ‘macerated’, ‘eczematous’); overall wound healing assessment since the last visit (‘healed’, ‘improved’, ‘stabilised’, ‘deteriorated’)
■
Pain assessed with a VAS from 0 (no pain) to 10 (the worst pain)
■
Method of debridement, if any performed
■ ■ ■ ■
Known allergy/ hypersensitivity to the dressing
Diabetes mellitus type, peripheral neuropathy confirmed by monofilament test; peripheral arterial disease (PAD) status, confirmed by recent vascular assessment
Follow-Up Parameters
Figure 1: Exclusion criteria.
Adult patients with uninfected DFUs suitable for application of the evaluated range of dressings
Patient demographics (age, sex)
Primary and secondary dressings applied, and number of dressing changes per week Offloading device used, such as casts, devices that immobilise the ankle joint and customised shoes Occurrence of any adverse event, including the incidence of infection and the associated treatment initiated Any other relevant comments, including shared care and whether care plans were followed
At A the Final Visit
■
The patient’s Health-related quality of life (HRQOL), using the EQ visual analogue scale (EQ-VAS)
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Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?
“The highest wound closure rate was patients without peripheral arterial disease (PAD) (85% at 20 weeks), but 50% patients with PAD achieved closure by 20 weeks. Those with a Sinbad score of 1 achieved wound closure faster than those with a Sinbad score of 2 or 3. Those who did not achieve wound closure achieved a relative wound area reduction.”
The primary study outcome was wound closure rate by week 20, which was defined as the wound covered by 100% epithelialisation and no exudate. Secondary outcomes were: time to reach wound closure, relative wound area reduction at week 20; change in pain and patients’ quality of life from the initial visit to the final assessment, and occurrence of wound infection or of any adverse event throughout the study period.
Results The study included 23 patients with noninfected DFU with an average age of 65 years (range 35-85). The majority of patients were male and had type 2 diabetes. 96% had peripheral neuropathy, 43% PAD, 30% reduced mobility, and 26% history of amputation. There was an overall impairment in the patients’ HRQoL at baseline. Patients with reduced mobility, women and older patients (75 years old) had on average a lower EQ-VAS score and, therefore, poorer HRQoL than the others. Sharp debridement was performed in all patients at each visit in order to remove callus and/ or wound debris. The contact layer was used to treat wounds covered by 30% or less of sloughy tissue, most often with low level of exudate, while the polyabsorbent dressing was selected to treat wounds covered by 50% or more of sloughy tissue, with low to high level of exudate. All wounds were then covered by an absorbent secondary dressing. During the course of the study, the dressings were changed once or twice a week. During the course of the study, 61% had an offloading device reported at all documented visits, seven patients (30%) were wearing their offloading device at all visits, except one or two (at presentation or at the final visit before healing or withdrawal), and poor adherence to offloading was reporting in two patients (9%), one being in a wheelchair. In the study, 70% of patients achieved wound
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closure by the end of the 20-week period and 81% of these had occurred by the sixth week of treatment. The 3 latest wound closures appear to have been affected by episodes of wound infection, suspected wound infection, and a large wound area at initial visit. The highest wound closure rate was patients without PAD (85% at 20 weeks), but 50% patients with PAD achieved closure by 20 weeks. Those with a Sinbad score of 1 achieved wound closure faster than those with a Sinbad score of 2 or 3. Those who did Table 2: SINBAD Score Table (from NFDA*) Category
Definition
SINBAD Score
Ischaemia
Pedal blood flow intact: at least one pulse palpable Clinical evidence of reduced pedal blood flow
0 1
Bacterial Infection
None Present
0 1
Depth
Ulcer confined to skin and subcutaneous tissue Ulcer reaching muscle, tendon, or deeper
0 1
not achieve wound closure achieved a relative wound area reduction. Five patients reported wound infections and these symptoms were assessed as localised infection which were associated with sudden wound deterioration or enlargement, and/ or periwound erythema, but none was associated with any pain. When infections was present, the dressing was temporarily changed to an antimicrobial, and then the UrgoStart range was recommended when infection cleared. Four patients reported positive pain scores over the duration of the study. The overall HRQoL of patients improved over the course
Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?
“Dialogue with the patient is also essential in the management of DFU. The severity of the condition should be explained to patients, their discomfort and pain assessed and managed, and their expectations discussed.”
of the study with a mean EQ-VAS score of 60.2 at baseline to 70.0 at the final visit (10 point difference on a 0-100 scale). The greatest gains in HRQoL scores were in those whose wounds healed by week 20 and who had the lowest score at baseline.
Discussion This study demonstrated that utilising UrgoStart dressings as initial local therapy per standard of care guidelines significantly benefited diabetic foot ulcer (DFU) healing. Aligning with National Diabetic Foot Care Audit recommendations, early specialist referral improves 3-month outcomes including ulcer-free survival, major amputation rates, hospitalization frequency, and inpatient stays. To facilitate prompt assessment, podiatrists serve an indispensable gatekeeping role in ensuring those with DFUs receive timely and appropriate treatment. While first line instigation of standard of care is vital, priority rests with expeditious diagnosis and care aligned with current evidenced-based protocols. Early UrgoStart application facilitates the optimisation of healing trajectories. By promptly focusing on agreed standards of care, patients benefit from coordinated treatment plans balancing established best practices with emerging technologies shown to accelerate closure in DFUs. The earlier UrgoStart dressings are used the greater the benefits for the patient are realised compared with other neutral dressings, in terms of closure rate, healing time or cost saving.9,11-12 Evidence already exists to support the recommendation to use UrgoStart dressings in the standard of care to treat patients with DFU without peripheral arterial disease (PAD), and the 70% would closure rate and 24 days median time to heal in this study provides further evidence to support this recommendation, and is consistent with previous evidence.6,13-5 In this study, in common with previous research,
the best outcomes were achieved in those with less severe DFUs, but those with more severe wounds (higher Sinbad scores, PAD and large area at baseline) still achieved substantial healing outcomes. 43% of patients in this study had PAD which is challenging, increasing the risk of rapid deterioration and limiting the availability of antibiotics at the site of infection. As diabetic foot infection is the most frequent diabetic complication requiring hospitalisation and is the most common precipitating event leading to lower extremity amputation in at risk of infection, rapid closure of the wounds, early diagnosis of wound infection and timely initiation of appropriate treatment can be limbsaving. Debridement is another key element of standard of care in the management of DFU; in this study, wound debridement was performed in all patients at each visit, in order to remove callus that contributes to pressure, free the wound edge and remove slough and nonviable, necrotic tissue that can delay the healing process and facilitate infection. After removal of the sloughy tissue, which may reappear during the healing process, the UrgoStart Plus polyabsorbant dressing is beneficial in continuously cleaning the wound of slough as it contains polyabsorbent fibres and therefore maintains a suitable environment for healing the granulation phase and until healing. As maceration can also affect the migration of the epithelialised cells from the wound edge, it appears to be important to appropriately choose a primary dressing adapted to the characteristics of each wound, in close contact with the wound bed, and, when necessary, to use a secondary dressing to support the exudate management. Dialogue with the patient is also essential in the management of DFU. The severity of the condition should be explained to patients, their discomfort and pain assessed and managed, and their expectations discussed. The closure of the wound requires several weeks to months,
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Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?
“It is clearly evident that early intervention with UrgoStart dressings can ensure faster healing in patients with DFU and improve quality of life. This study should give confidence to clinicians that they can implement evidence based practice effectively within their own clinical area.”
and it is important that the patients adhere to their treatment, including the use of off loading devices. This study used an alternative off loading method for the majority of patients which was routinely available (felt padding) compared with what is considered gold standard practice e.g total contact casting which was unavailable locally. However this did not affect the positive clinical outcomes. In this study, all the patients were provided offloading devices, although of different types, in order to take into account their needs and daily constraints, and facilitate their adherence to the offloading therapy.
Conclusion This small study in real life prompted the local specialist podiatry team to evaluate their current practice and the service they delivered to patients. The outcomes of this evaluation reflects the results of previous published clinical research and supports the recommendation from NICE. It is clearly evident that early intervention with UrgoStart dressings can ensure faster healing in patients with DFU and improve quality of life. This study should give confidence to clinicians that they can implement evidence based practice effectively within their own clinical area.
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References 1. Kerr M (2017) Improving Foot Care for People with Diabetes and Saving Money An Economic Study in England. Diabetes UK. Available at: http://bit.ly/2sXYHFp (accessed 22.05.2017) 2. Goodeve M, Saunders L, Grothier L (2022) Service evaluation: the benefts of TLCNOSF dressings on patients with diabetic foot ulcers. The Diabetic Foot Journal Harrogate: 44–54 3. Kerr M, Barron E, Chadwick P et al (2019) The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med 36(8): 995–1002 4. Ismail K, Winkley K, Stahl D et al (2007) A cohort study of people with diabetes and their frst foot ulcer: the role of depression on mortality. Diabetes Care 30(6): 1473–9 5. Reinboldt-Jockenhöfer F, Babadagi Z, Hoppe HD, et al (2021) Association of wound genesis on varying aspects of health-related quality of life in patients with different types of chronic wounds: Results of a cross-sectional multicentre study. Int Wound J 18(4): 432–439 6. NICE (2019) Diabetic Foot Problems: Prevention and Management. NICE Guideline [NG19]. London: NICE. Available at: https://www. nice.org.uk/guidance/ng19 (accessed 25.10.2022) 7. Schaper NC, van Netten JJ, Apelqvist J et al (2020) Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev 36(Suppl 1): e3266. doi: 10.1002/dmrr.3266. PMID: 32176447. 8. NICE (2019). UrgoStart for Treating Diabetic Foot Ulcers and Leg Ulcers. Medical Technologies Guidance [MTG42]. London: NICE. Available at: https://www.nice.org.uk/ guidance/mtg42 (accessed 25.10.2022) 9. Lázaro JL, Izzo V, Meaume S et al (2016) Elevated levels of matrixmetalloproteinases and chronic wound healing: an updated review of clinical evidence. J Wound Care 25(5): 277–87 10. Jeffcoate J, Gooday C, Harrington A et al (2020) The National Diabetes Foot Care Audit of England and Wales: achievements and challenges. The Diabetic Foot Journal 23(1): 70–3 11. Lobmann R, Grünerbel A, Lawall H et al (2020) Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing. J Wound Care 29(10): 543–51 12. Maunoury F, Oury A, Fortin S et al (2021) Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One 16(1): e0245652. doi: 10.1371/journal.pone.0245652 13. Meloni M, Bouillet B, Ahluwalia R et al (2021) Fast-track pathway for diabetic foot ulceration during COVID-19 crisis: A document from International Diabetic Foot Care Group and D-Foot International. Diabetes Metab Res Rev 37(3): e3396. doi: 10.1002/dmrr.3396 14. Meloni M, Izzo V, Manu C et al (2019) Fast-track pathway: an easyto-use tool to reduce delayed referral and amputations in diabetic patients with foot ulceration. The Diabetic Foot Journal 22(2): 38–47 15. Tickle J (2021) NICE guidance in real life: Implementation of an evidence-based care pathway within a new wound healing 16. Goodeve M, Saunders L, Grothier L (2022), Service evaluation: the benefits of TLC-NOSF dressings on patients with diabetic foot ulcers. The Diabetic Foot Journal 25(4): 1-11
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Introducing Wound Masterclass Video
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A Versatile Framework to Quickly Implement Wound Care-Specific, RoleBased Competency Programs Editorial Summary Establishing competency is a critical component of evidence-based wound care. However, developing comprehensive competency programs for our specialized field can be an arduous undertaking. A streamlined framework provides a versatile solution that allows clinicians to quickly implement targeted wound care competency programs based on staff roles. The framework categorizes competencies into domains, classes, and subclasses, enabling organizations to identify exactly which skills are relevant for different positions. It incorporates recommendations from guiding bodies and allows competencies to be consistently updated as the field evolves. Leveraging this framework, clinicians can work with team members to rapidly develop role-based competency programs. Gap analysis tools can further enhance efficiency. With competency checkpoints tied directly to patient care initiatives, organizations can readily demonstrate the impact of their education programs. This modular, wound-specific competency framework allows clinicians to swiftly establish comprehensive yet focused competency initiatives for all wound care staff. Doing so elevates patient care through evidence-based practice while meeting regulatory requirements.
Introduction
S
taffing shortages have been a top patient safety concern.1 The need to quickly onboard new clinicians and ensure competent performance is compounded by the lack of a standardized approach to education/ training in wound care.2,3 It has been shown that organizations with competency programs have 40% lower turnover and 87% greater ability to hire the best people.4 However, consistently ensuring clinicians’ competency in wound care is challenging, given time/ resource constraints.
Objective To address these needs, we aimed to create a framework to quickly implement role-specific, wound care competency programs.
Method Dr Elaine H. Song
Ms Catherine T. Milne
Ms Tiffany Hamm
Co-Founder and Chief Executive Officer of WoundReference, Inc.
Advanced Practice Wound, Ostomy Continence Nurse, Connecticut Clinical Nursing Associates
Vice President, Global Research Development at The Henry M. Jackson Foundation for the Advancement of Military Medicine
Walnut Creek CA, United States
Bristol CT, United States
Rockville MD, United States
The method used is demonstrated by Figure 1:
Figure 1: Managers/clinicians’ needs, and role-based competency areas in wound care were mapped
Ms Nataliya Lebedinskaya
Ms Janis Prado
Mr Jeff Mize
RN, CWOCN, Kaiser Foundation Health Plan
CWOCN at Kaiser Permanente
Principal Partner at Midwest Hyperbaric LLC Co-Founder at Wound Reference Inc: Chief Clinical Officer & Business Development Officer
Concord CA, United States
Oakley CA, United States
Overland Park KS, United States
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Using the Design Thinking methodology,5 the solution* was created as a module within a clinical/ reimbursement decision support web-application for wound care/ hyperbaric clinicians
Role-based competency templates/training modules featuring evidencebased content, continuing education credits, and skills were built
Playbook for customization of the competency program was created
Framework was implemented in several organizations
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A Versatile Framework to Quickly Implement Wound Care-Specific, Role-Based Competency Programs
"The need to quickly onboard new clinicians and ensure competent performance is compounded by the lack of a standardized approach to education/training in wound care."
Results The framework is a digital solution that enables organizations to quickly implement/manage/document wound carespecific, role-based competencies.
Use cases include ongoing competencies for:
Acute Care Inpatient Nurses
Certified Wound Care Specialists
HBOT Professional Certification
To achieve quality goals, a hospital implemented customized pressure ulcer/injury prevention competencies for 330 nurses, cutting down educational program development time by 80%.
To complement their organization’s generic competencies and ensure their own competencies addressed their job duties/ responsibilities, specialists implemented wound-care specific competencies, reinforcing regulatory compliance.
To address lack of local qualified supervisor, candidate completed a Preceptorship Module utilizing an in-person/ remote approach and met preceptorship requirements to become a Certified Hyperbaric Technologist.
Conclusion
accreditation and regulatory requirements.
A framework to quickly deploy wound carespecific, role-based competency programs and meet continuing education/ certification/ compliance requirements was successfully developed/implemented. Its versatility may help organizations address staffing turnover by decreasing onboarding time, and increasing talent retention.
Most importantly, wound care competency programs centered on the needs of the patient enable us to provide compassionate, effective treatment to those suffering with wounds. They allow us to serve as collaborative partners focused on activating patients’ innate healing capacities. By investing in the professional development of our wound care workforce through efficient and adaptable competency frameworks, we can spread the transformational power of growth, knowledge, and purposeful skills.
Implementing targeted wound care competency programs utilizing efficient frameworks provides multiplicative benefits across the breadth of our field. For individual clinicians, clearly defined competency standards reinforced through continuing education elevate the care we provide by keeping our knowledge and skills aligned with current best practices. For wound care centers and organizations, structured competency programs allow them to consistently deliver high-quality, evidence-based care that leads to improved patient outcomes. Standardized programs also facilitate meeting
© Copyright. Wound Masterclass. 2023
References 1. ECRI. ECRI Reports Staffing Shortages and Clinician Mental Health are Top Threats to Patient Safety [Internet]. ECRI. 2022. Available from: https://www.ecri.org/press/ecri-reports-staffing-shortages-and-clinician-mental-health-are-topthreats 2. Williams EM, Deering S. Achieving competency in wound care: an innovative training module using the long-term care setting. Int Wound J. 2016 Oct;13(5):829–32. 3. Corriveau G, Couturier Y, Camden C. Developing competencies of nurses in wound care: the impact of a new service delivery model including teleassistance. J Contin Educ Nurs. 2020 Dec 1;51(12):547–55. 4. Garr S. Integrated Talent Management: A Roadmap for Success. Research Bulletin. 2012 Oct 19; 5. Ferreira FK, Song EH, Gomes H, Garcia EB, Ferreira LM. New mindset in scientific method in the health field: Design Thinking. Clinics. 2015 Dec 10;70(12):770–2. 6. Mize J, Hamm T. Quality of Care Requires Ongoing Competency Evaluations [Internet]. Woundreference.com. 2021. Available from: https://woundreference.com/blog?id=competency-assessments 7. The Joint Commission. About Our Standards | The Joint Commission [Internet]. 2021 [cited 2021 Jul 15]. Available from: https://www.jointcommission.org/standards/about-our-standards/
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How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide Editorial Summary Expanding upon the well-established TIME wound bed preparation protocol, M.O.I.S.T., an enhanced educational model designed by Wund-DACH researchers empowers healthcare practitioners to make well-informed and balanced decisions in the topical treatment of chronic wounds. Serving as a reference tool, the model advocates for a systematic and harmonized approach to wound care, thereby bolstering the practitioners' confidence in their treatment choices. Comprising 5 essential factors (Moisture, Oxygen, Infection, Support, and Tissue), the model offers a comprehensive framework that allows practitioners to adapt to the individual patient's requirements, elevating wound care practices to new levels of effectiveness and patient-centered care.
Introduction
W
ound care is a complex therapy area, with many variables impacting on the process of wound healing. Often, patients present with multiple co-morbidities that can directly or indirectly affect wound healing. Chronic wounds are, by their nature, wounds which take a longer time to heal. These include diabetic foot ulcers (DFUs), pressure ulcers/injuries (PI/Us), leg ulcers of different etiologies, and burns. These wounds are open areas or lesions which may present with significant tissue loss and contain a range of tissue types, spanning from healthy appearing granulation tissue to necrotic tissue and slough. Additionally these wounds frequently produce excessive levels of exudate which can negatively affect the wound and the surrounding skin. Chronic wounds can also be painful, malodorous, debilitating, and are often responsible for directly affecting the quality of life of the patient. This is not only a burden for the patient, but also for their families and carers.
Mr John Timmons International Medical Director, Mölnlycke Glasgow, United Kingdom
The financial burden of wounds within many health care systems may go relatively unrecognised due to the complex nature of the problem, lack of a unified approach, and the associated comorbidities.1
Assoc Prof Matthew Malone
Prof Dr Joachim Dissemond
Principle Scientist, R&D Bioactives and Wound Biology & Conjoint A. Professor Infectious Diseases and Microbiology, School of Medicine, Western Sydney University
Clinic for Dermatology, University Hospital Essen Essen, Germany
Macclesfield, United Kingdom
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A leading health economist in the United Kingdom has managed to successfully model the true financial cost of wound care in the National Health Service (NHS) and has found that the cost of wound care continues to grow despite advances in wound care knowledge and available technology. Some would argue that this technology has not yet made a significant impact on the delivery of care. In one of the latest of these studies, Guest et al. (2017) suggest that wound care is often within a non-specialist environment and that this can in some cases lead to extended healing times with care episodes not being optimized. There is also significant pressure in many markets related to the cost of wound dressings despite little proof that the price of dressings is the root cause of care expense. In fact, Guest et al. have calculated that the cost of wound dressings is
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How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide Figure 1: HEIDI
MOIST
Outcome measures
History, Examination, Investigation, Diagnosis and Implementation
Moisture Oxygen Infection Support Tissue
Patient reported PROMS Clinical outcomes Economic outcomes
Holistic
Contents
Social or Environmental Patient experience
Using M.O.I.S.T. concept to enhance wound care and improve healing outcomes
only 6% of the cost of wound care. Most wound care costs incurred are associated with the costs of time for the clinician, clinic visits, and overheads for the facility where the patient is being treated.2 Professor Joachim Dissemond, Dermatology and Venerology Consultant with the additional discipline of Allergology, has practised at the Dermatology Clinic, Essen University Hospital, since 1999, initially as an Assistant Physician and then as a Senior Physician since 2003. A Wound Outpatient Clinic was set up at Essen University Hospital on Professor Dissemond’s initiative. The Dermatology Clinic is nowadays recognized as an interdisciplinary wound center.
Common Wound Etiologies Where M.O.I.S.T. May Be Applicable Chronic wounds can have many different causes. They are often characterised by their extended healing times, presence of sloughy tissue, excessive bioburden, and high levels of exudate.3 Coupled with underlying disease processes such as in the case of foot ulcers in diabetes, leg ulcers in patients with chronic venous insufficiency, and pressure ulcers in patients with restricted mobility, there are often many facets to the non-healing wound. Wound chronicity can be characterized in different ways. The cause of chronicity may be time driven, meaning the longer a wound is open, the environment will change. Exposure to
bacteria in and around the wound will increase the bioburden and promote the development of bacterial biofilm and promotion of a persistently inflamed state. This hostile environment will lead to an increase in matrix and bacterial proteases which lead to off target destruction of host proteins, cellular senescence, and delayed healing. One may also think of a chronic wound as one that is found on a chronic patient, with comorbid conditions which may be the source of the wound (e.g., venous and/ or arterial insufficiency, diabetes) or a strong contributing factor (e.g., immobility, renal or pulmonary disease, cancer, autoimmune diseases) or drugs that can slow healing, in addition to chemotherapeutic agents, such as cytotoxic antineoplastic and immunosuppressive agents; corticosteroids, nonsteroidal anti-inflamatory drugs (NSAIDs), anticoagulants mTOR inhibitors (rapamycin), and hydroxyurea or tyrosine kinase inhibitors such as imatinib. Therefore, it is not only important to address the immediate issues on the wound bed itself but also the underlying pathology which contributes to wound chronicity.
Why Adopt M.O.I.S.T. ? In the absence of a consistent methodology, there have been many attempts to simplify approaches to the non-healing wound in order to make the assessment and management easier to understand and implement. One of the more successful of these was the TIME concept.4 The TIME concept was created by a group of expert clinicians to summarize the main steps of wound bed preparation. In short, the TIME acronym looked at T for tissue management, I for infection or inflammation, M for moisture management, and E for wound edge. In 2016, a group of clinicians brought together by WundDACH, the umbrella organization of German speaking wound healing societies, discussed the need to further develop the TIME concept to include some other aspects that should be considered in wound care today.5 This alternative approach appeared necessary because, after 15 years, new therapeutic options have emerged that could not be represented in the TIME concept, which focused primarily on wound bed preparation. The acronym for this new approach is known as M.O.I.S.T. The letters in this acronym stand for
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How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide
“A good nutritional status is also an essential part of the care of patients with wounds in order to promote healing, and the management of pain should also be considered in the patients’ care.”
Moisture balance, Oxygen balance, Infection control, Supporting therapies, and Tissue management.5 This new acronym was not designed to be used in order but rather an aide memoire for the clinician who manages patients with chronic wounds.
Figure 2: How M.O.I.S.T. should be included in the overall patient assessment.
Supporting Therapies
Local Wound Treatment
Patient Assessment and the Use of M.O.I.S.T. As a Clinical Decision Aid In this article we will examine each of the letters of M.O.I.S.T. and how they may be used to support practice and aid in creating the appropriate treatment approach for the patient. As with all wound care treatment and assessment systems, it is important to use a holistic framework in order to address all the needs of the patient. Therefore, the M.O.I.S.T. concept should be used in the context of the overall care of the patient. This will include full assessment of the patient, including all medical history and concurrent conditions, and a full assessment of the wound including duration, size and etiology; assuring that with the other supporting therapies, for example in patients with underlying venous and lymphatic disease, the patient will undergo a vascular evaluation, leading to appropriate compression therapy, as well as appropriate skin care. For patients with diabetes related foot ulcers, full assessment of neuropathy and potential ischemia will be necessary and off-loading devices will be used to support the overall approach to wound care. A good nutritional status is also an essential part of the care of patients with wounds in order to promote healing, and the management of pain should also be considered in the patients’ care. Figure 2 illustrates how M.O.I.S.T. should be included in the overall patient assessment.
M.
Patient & Wound
T.
O. I. S.
for wound healing, with early studies showing that achieving the correct moisture balance will promote healing.6 Wounds which are dry are likely to take a longer time to heal as a scab can form over the wound, and in turn the new cells have to burrow underneath in order to continue healing. In the meantime, the benefit has also been well proven scientifically, so that moist wound therapy is now recommended in most expert recommendations and guidelines.7,8 Exudate is an essential component of wound healing and provides an environment conducive to new tissue growth, enabling the presence of appropriate inflammatory mediators and growth factors into the wound bed and to act as a medium for migration of cells such as keratinocytes across the wound bed.9 Wound exudate also contains essential nutrients which are needed for cell metabolism. In addition to this, the presence of exudate supports the removal of dead tissue through autolysis.
M = Moisture Balance The creation of a moist wound environment has long been accepted as the gold standard
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In chronic wounds, the wound environment can be complicated with the presence of excessive exudate levels caused by a prolonged
How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide
“Many wound dressings now exist which can help to support the optimal moisture balance within the wound bed, some of which contain a silicon wound contact layer which not only promotes healing but facilitates pain reduction on dressing removal.”
inflammation. Chronic wound exudate has been shown to contain excessive levels of inflammatory mediators such as matrix metalloproteases (MMPs). When these exist in high amounts they can start to degrade the new extracellular matrix and the new tissue, which will prolong the inflammatory phase and therefore wound healing (Figure 3). It is also worth noting that most chronic wounds will also have an excessive bioburden, potentially as planktonic bacteria or bacteria encased in a biofilm, which in itself triggers the body's inflammatory response, leading to greater exudate production creating a cycle of continuous inflammation. Excessive moisture levels are not only detrimental to healing in the wound bed, but if not managed appropriately Figure 3: Pressure ulcer with poor exudate management. Note the damage to the surrounding skin caused by toxic contact dermatitis.
they can lead to maceration of the surrounding skin and ultimately, skin breakdown.9 When selecting a wound dressing, the goal should be achieving the optimal balance of moisture supporting a moist wound bed whilst absorbing and handling excessive exudate in order to promote wound healing and prevent maceration of the surrounding
skin.10 The dressing should also be able to adequately retain or move the exudate into a secondary dressing when external pressure is applied, in order to prevent the exudate from pooling on the wound bed and surrounding tissues, as in patients receiving compression therapy or those with foot ulcers who have a total contact cast in situ. Many wound dressings now exist which can help to support the optimal moisture balance within the wound bed, some of which contain a silicon wound contact layer which not only promotes healing but facilitates pain reduction on dressing removal.
O = Oxygen Balance Oxygen is an essential component for many physiological processes and also has a direct impact on wound healing. Many problems with wound healing begin and end with an issue relating to oxygen levels in the wound and surrounding tissues. Oxygen is a vital requirement for every step in the wound healing process, including angiogenesis, revascularization, synthesis of connective tissue, and resistance to infection.11 Oxygen availability is a clear predictor for wound healing outcome; just 3% of wounds with an extremely low oxygen concentration heal, compared to 95% of wounds with a normal oxygen concentration.12 Hypoxia is often the case in lower limb wounds where arterial disease results in decreased blood supply and even in venous disease where there is reduced oxygen due to vascular inefficiency secondary to edema in the surrounding tissue. Without oxygen, many cellular functions cannot be supported and in chronic wounds this can result in slow healing. Interventions that can help to improve tissue oxygenation include reperfusion/ revascularization surgery to help re-establish the arterial blood supply, which would then support oxygen transport to the wound site.
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“The majority of chronic wounds will contain bacteria in the form of planktonic bacteria, and also biofilm. The presence of high levels of bacteria, and often the compromised immunity of the patient or host, can lead to systemic infection.”
Compression therapy in the case of venous leg ulcers (VLUs) is an essential part of the treatment which helps to reduce edema in the limb, improving overall vascular efficacy by reducing distance diffusion of oxygen; over time wound healing should improve.13 More recently, products and therapies which supply oxygen directly or indirectly to the wound bed have been introduced, which facilitate the delivery of oxygen directly to the wound bed.14 This encourages wound healing by increasing the amount of available oxygen. Arenberger et al. conducted a small randomized controlled trial (RCT) in 2011 of a haemoglobin spray on chronic ulcers of various types, which showed 93% healing at 6 months with haemoglobin spray compared with 7% healing without haemoglobin spray. There was a 93% success rate of healing (n = 42) with the haemoglobin spray group versus the control.15
I = Infection Control Infection is one of the biggest challenges for patients with wounds and for health care services. By their nature, chronic wounds are open skin defects which have been present for long periods of time.16 The wound bed is often complex, with many tissue types present, including slough, fibrin, and necrotic tissue. The majority of chronic wounds will contain bacteria in the form of planktonic bacteria, and also biofilm. The presence of high levels of bacteria, and often the compromised immunity of the patient or host, can lead to systemic infection.16 Wounds are an ideal growth environment for bacteria due to the warm temperature, the presence of a food source (the wound tissue and sloughy tissue present), oxygen from the environment is readily available, and in many patients with co-morbidities immunity can be reduced, which makes them more susceptible to infection (Figure 4).
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Figure 4: Spreading infection and cellulitis as a result of VLU.
In recent years it has also been identified that open chronic wounds are likely to contain biofilm which cause chronic infections and delayed wound healing.17 Biofilms form when bacteria aggregate (meaning forming a clump of cells), attach to a surface, change the way they behave and produce a protective matrix. This contributes to enhanced tolerance to many therapeutics and the host immune system. When assessing a wound that is infected, there are usually visible signs associated with infection and excessive bacterial proliferation. These signs include but are not limited to: local redness, local heat, swelling/ edema, increasing pain, and loss of function. Other signs include excessive exudate and/ or a change in the type of exudate being produced; that is, the exudate may be thicker or more purulent in nature.16 The TILI score, a therapeutic index, designed by Dissemond et al., aims to help health professionals, in particular those not specialists in would care management, in the early identification of patients with locally infected wounds. It assesses 6 clinical criteria for local wound infection, including erythema of the surrounding skin; localised heat; edema, induration or swelling; spontaneous pain or pressure pain; stalled
How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide
“It is important to note that patients with diabetes or autoimmune disorders may not exhibit the traditional signs of infection, making detection difficult; with these patient groups it is therefore important to proceed with caution, and the use of antimicrobials and antibiotics may be necessary for longer periods of time.”
wound healing; and increase and/ or change in colour or smell of exudate. If the wound meets 5 of the criteria, then antimicrobial treatment can be commenced.18 Depending on the results of the clinical evaluation to be performed, this score could provide the basis for early intervention with a selective and time-limited use of localized wound therapy in patients with infected wounds. When faced with a wound infection, it is important to act quickly to reduce the levels of bacteria and to prevent spread locally and systemically. This is best achieved by physical removal of non-viable or infected tissue such as debridement, and effective and repeated cleansing of the wound and periwound skin using a safe cleansing solution (for example, polihexanide or hypochlorous acid). Further extended antimicrobial activity can be achieved through the use of topical antimicrobial agents and dressings. It is important to note that patients with diabetes or autoimmune disorders may not exhibit the traditional signs of infection, making detection difficult; with these patient groups it is therefore important to proceed with caution, and the use of antimicrobials and antibiotics may be necessary for longer periods of time.
S = Support the Wound Bed When it comes to the treatment of problematic wounds that do not heal as expected, there are various strategies available to help rebalance the environment inside the wound bed and facilitate the healing process. These strategies aim to address specific factors that may be impeding the healing progress and promote a more favorable environment for wound healing. One approach is to control and bind excessive MMPs within the wound bed. MMPs are enzymes that play a crucial role in the breakdown of extracellular matrix components;
however, when their activity becomes excessive, it can lead to the degradation of healthy tissue and hinder wound healing. By utilizing therapies or dressings that effectively inhibit or bind these MMPs, the excessive proteolytic activity can be controlled, allowing for a more balanced healing process. Optimizing the pH conditions within the wound bed is another important aspect of promoting wound healing. An optimal pH range is necessary for the activation of enzymes involved in various stages of the healing process. Deviations from the normal pH range can impair enzyme activity and delay healing. Therefore, treatments that focus on maintaining the appropriate pH levels within the wound bed can help create an environment conducive to healing. There has not been a consensus of evidence supporting the optimal pH for wound healing. Protecting growth factors is another strategy employed to facilitate wound healing. Growth factors are signaling molecules that regulate cellular activities and play a vital role in wound repair; however, they can be easily degraded or inactivated within the wound environment, which can hinder their effectiveness. Various techniques, such as the use of growth factor delivery systems or dressings that protect and release growth factors in a controlled manner, can help ensure their sustained presence and activity within the wound bed. Controlling pro-inflammatory mediators is also crucial for successful wound healing. While inflammation is a natural part of the healing process, an excessive or prolonged inflammatory response can impede healing and contribute to chronic wound formation. Therapies that target specific pro-inflammatory mediators or modulate the inflammatory cascade can help regulate the inflammatory response and create a more favorable environment for
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How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide
“A healthy wound bed is crucial for effective wound healing; in order to create an optimal environment for healing, it is necessary to clean and prepare the wound bed by removing any dead cells and tissue.”
healing.
Biosurgical debridement
In addition to these strategies, the use of collagen dressings can be beneficial for wound healing. Collagen, a major component of the extracellular matrix, provides structural support and promotes cell migration and proliferation. Collagen dressings can help facilitate the formation of granulation tissue, aid in wound contraction, and provide a moist wound environment, which is conducive to healing.
This method involves the application of sterile maggots to the wound. Maggots secrete enzymes that selectively break down necrotic tissue, while leaving healthy tissue intact. This method has been used for centuries and has shown efficacy in promoting wound healing.
Overall, these therapeutic and treatment choices, such as controlling MMPs, optimizing pH conditions, protecting growth factors, controlling pro-inflammatory mediators, and utilizing collagen dressings, work together to rebalance the wound environment and promote the healing process. By addressing specific factors that may be inhibiting healing, these strategies can help get the healing of problematic wounds back on track and improve overall patient outcomes.
T = Tissue Management A healthy wound bed is crucial for effective wound healing; in order to create an optimal environment for healing, it is necessary to clean and prepare the wound bed by removing any dead cells and tissue. This process, known as debridement, can be achieved through various methods depending on the nature and condition of the wound. Autolytic debridement This method involves the use of moistureretentive dressings that promote the body’s natural enzymatic processes to break down and remove necrotic or non-viable tissue. By maintaining a moist environment, autolytic debridement allows the body’s own enzymes to selectively degrade the dead tissue, while preserving healthy tissue.
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Surgical debridement As the name suggests, this method involves the removal of necrotic or non-viable tissue through a surgical procedure. Sharp surgical debridement is often used in cases where extensive debridement is required, such as in deep wounds, or wounds with significant infection. It allows for precise removal of unhealthy tissue and enables a clean wound bed for subsequent healing. Enzymatic debridement This method of debridement involves the use of topical enzymes that selectively break down necrotic tissue. These enzymes are applied to the wound bed and left for a specific duration, after which the wound is cleansed. Enzymatic debridement is particularly useful in wounds with thick or adherent necrotic tissue. Mechanical debridement These methods involve physically removing necrotic tissue through techniques such as wetto-dry dressings, wound irrigation, or the use of specialized instruments. Wet-to-dry dressings involve applying a moist dressing to the wound, which is allowed to dry and adhere to the necrotic tissue; upon removal, the dressing lifts away the dead tissue. Wound irrigation utilizes a gentle stream of fluid to flush away debris and necrotic tissue. Specialized instruments, such as curettes or forceps, may be used to mechanically remove non-viable tissue.
How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide In addition to debridement, certain treatment options can enhance its effects and promote wound healing. Negative pressure wound therapy (NPWT) involves the application of a vacuum system to the wound bed, which helps remove excess fluid, stimulate blood flow, and promote granulation tissue formation. Electrical stimulation and ultrasound therapy are physical therapies that can also enhance debridement by promoting cell growth, increasing blood flow, and reducing inflammation in the wound bed.
with eschar, is normally black in colour, is dry and leathery in appearance, and can be difficult to remove. This tissue will be a physical impediment to healing so must be removed to allow wound healing to take place. The quickest way to achieve this would be sharp debridement, however, this may not be suitable for all patients. Some autolytic gel products can be used to help soften the necrosis, but this may take significant time (Figure 5a). Sloughy Tissue
Overall, a combination of cleansing the wound bed with appropriate solutions, employing different debridement methods such as autolytic, biosurgical, surgical, enzymatic, or mechanical techniques, and utilizing adjunctive therapies like NPWT, electrical stimulation, or ultrasound can help prepare the wound bed for optimal healing and improve outcomes for patients. In most chronic wounds, debridement focuses on specific targets depending on the stage of wound healing. These targets encompass various aspects, including necrosis, slough, eschar, impaired tissue, sources of inflammation, sources of infection, exudate, serocrusts, hyperkeratosis, pus, hematomas, foreign bodies, debris, bone fragments, and other types of bioburden or barriers to healing. Effective debridement aims to remove these elements and promote a cleaner wound bed, allowing for improved healing and optimal wound management.
Types of Tissue Necrotic Tissue
This often looks yellow, grey and/ or white in appearance. This tissue consists of white blood cells, dead tissue, bacteria and debris. This is also a physical barrier to wound healing and as stated above, can act as a reservoir for bacteria. As with necrotic tissue, slough should be removed with sharp debridement where possible, and gelling fibre products or hydrogels can be used in between debridement episodes to support autolytic debridement, depending on exudate levels (Figure 5b, 5c). Granulation Tissue Granulation tissue is the name given to the new tissue which is forming in the wound bed, due to its granular or bumpy appearance. Normal, healthy granulation tissue should be red in colour, not dark or grey which could indicate infection. Granulation tissue is a good sign that the wound is progressing towards healing. This tissue needs to be protected and prevented from drying out. Products used should maintain optimal moisture balance and may include wound contact layers, foam dressings and if necessary gelling fibre products when exudate levels are high (Figure 5d).
Necrotic tissue is when the wound is covered
Figure 5a: This pressure ulcer in an elderly female is covered with hard eschar. Figure 5b: The majority of this wound is covered with sloughy tissue, not also the exudate on the wound surface. 5a
5b
5c
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“Once the wound has been cleansed and debrided, there is a small window (<24 hours) during which biofilm can reform or may be more sensitive to antimicrobials; therefore, one strategy to help reduce or prevent biofilm reformation is to use topical antimicrobial products on the wound surface at this time.”
Epithelial Tissue Epithelial tissue is the tissue that grows over the top of the wound once granulation is complete. This should be pink in colour and often is seen beginning to form at the wound edges and also on the wound surface where hair follicles may be present. These are often seen as ‘islands’ of epithelial tissue. As with granulation tissue, epithelial tissue should be protected from physical damage and from drying out, as this will allow the new cells to migrate across the wound surface. Dressings may include wound contact layers and silicone foam dressings.
Biofilm Most chronic wounds not responding to standard of care have been shown to contain biofilm.19 Biofilm is the term used when microorganisms demonstrate altered behaviours; growth, metabolism, virulence, communication, and production of a protective matrix. Biofilms may form with the same species of microorganisms or as complex polymicrobial communities, however the principle function of biofilm is to protect the microbes from attack by therapeutics and the host immune system. Importantly, biofilms are not visible to the eye and the microorganisms are often spread heterogeneously within wound tissue; biofilms do not just form evenly over the surface of a wound, but may exist as small aggregates of cells deeper in wound tissue. Biofilms cause chronic infections as the host immune system struggles to clear them from the tissue, and many therapeutics do not work as efficiently. Ultimately, the downstream effects of chronic infection are the continuous induction of host inflammatory mediators, which damages host tissue.20 The result is that wound healing can be stalled or slowed down and exudate levels may increase. Biofilms can re-form very quickly (within hours to days) and reach full maturity within 3 days. Most of the
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literature agrees that wounds with mature biofilm are much more tolerant to therapies, thus are harder to heal than those with young, less mature biofilms present. The most effective way to remove biofilm is through physical removal, such as regular sharp and mechanical debridement. However, debridement alone does not remove all biofilm because clinicians cannot see where they are exactly located within a wound. Consensus guidelines therefore propose that following debridement there is value in utilizing cleansing agents (e.g., hypochlorous acid) and/ or the application of topical antimicrobial dressings to ‘mop up' or reduce any residual microorganisms in the wound. Once the wound has been cleansed and debrided, there is a small window (<24 hours) during which biofilm can reform or may be more sensitive to antimicrobials; therefore, one strategy to help reduce or prevent biofilm reformation is to use topical antimicrobial products on the wound surface at this time. More frequent debridement may also be needed in order to tip the scales of reducing the biofilm before it quickly reforms.
Using M.O.I.S.T. To Help Support Clinical Practice
72-year-old male •
1-week duration diabetes-related foot ulcer (DFU) with associated acute infection
•
Depression, Hypertension,Type 2 Diabetes Mellitus, Dyslipidaemia, and Peripheral Neuropathy
•
DFU extends from the plantar 4th metatarsal head to the dorsal 4th interdigital space
•
Measured 1.5 cm2 (area) with a depth ranging from 0 to 3 cm
How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide •
The DFU was interconnected from the plantar 4th metatarsal head to the dorsal 4th interdigital space of the left foot; it measured 1.5 cm2 (area) with a depth ranging from 0 to 3 cm
•
Tissue management: The wound bed was composed of 14% sloughy and 86% granulating tissue
•
Infection control: The ulcer was associated with a moderate skin and soft tissue infection with cellulitis requiring outpatient based intravenous antibiotic therapy for 2 weeks
•
Tissue management: Curettage sharp debridement of the wound bed was only required at the baseline and initial study assessment
•
Infection control: The wound was cleansed with Granudacyn® (wound irrigation solution containing hypochlorous acid, Mölnlycke, Gothenburg, Sweden) at all dressing changes until the final study assessment when normal saline was used
•
At baseline, the wound was dressed (primary dressing) with Exufiber® Ag+ (silver-containing gelling fibre dressing, Mölnlycke, Gothenburg, Sweden) and Mepilex® (secondary dressing) (foam dressing, Mölnlycke, Gothenburg, Sweden))
•
Moisture management: Exudate levels were moderate, viscous, and purulent in appearance
•
The peri-wound skin was macerated (Figure 6a)
•
After 27 days of treatment, only Mepilex® was required
•
The ulcer had previously been treated with Inadine® (povidone-iodine impregnated dressing. 3M™, Maplewood, MN, United States) and Allevyn® Foam (foam dressing, Smith & Nephew, London, United Kingdom)
•
Throughout the study, Mefix® (adhesive dressing, Mölnlycke, Gothenburg, Sweden) was used for dressing fixation, and a CAM walker was used for offloading
•
The patient experienced no pain prior to and during dressing removal, during wound irrigation, and upon application of the study dressings
Dressings were changed at each study assessment and in between these visits the patient changed the dressings every 3 days, as per clinician directions
•
Follow-up assessments: After 27 days of treatment, the wound area was almost healed (Figure 6c)
•
Tissue management: The composition of the wound bed tissue steadily improved over the study period, and at the final
•
Treatment Regime A detailed wound evaluation was completed at a baseline assessment and 2 further scheduled study visits over a period of 27 days (Figure 6b).
Figure 6a: Start of evaluation (day 1). A 2-month-old foot ulcer with moderate levels of purulent, viscous exudate. The wound bed tissue was 14% sloughy and 86% granulating tissue. The peri-wound was macerated. Figure 6b: After 16 days of treatment, exudation was low, viscous, and clear/serous in appearance. The wound bed tissue was 5% sloughy and 95% granulating. Figure 6c: End of evaluation (day 27) At the final follow-up visit, the wound was almost healed. The wound bed was composed of 100% granulating tissue. 6a
6b
6c
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How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide study assessment was composed of 100% granulation tissue •
Infection control: All clinical signs of wound infection were resolved after 27 days of treatment
•
Moisture management: After 16 days of treatment, wound exudate levels were low and clear/ serous in appearance but remained viscous; at the final study assessment it was non-viscous
•
Throughout the study, the peri-wound skin was healthy. The patient remained painfree during all dressing change procedures throughout the study
as indicated by the classic signs of inflammation, warmth, and erythema. Oral antibiotics were prescribed •
Moisture balance: Exudate levels were high; viscous and yellow/ green in appearance, with wound malodor. The peri-wound skin was hyperkeratotic. The wound had previously been cleansed using normal saline, and dressed with Inadine® (povidone-iodine impregnated dressing, 3M™, Maplewood, MN, United States) and Zetuvit® (absorbent dressing, Hartmann, Heidenheim, Germany)
•
The patient was pain-free prior to and during dressing removal, during wound irrigation, and upon application of the study dressings due to loss of protective sensation (peripheral neuropathy)
Clinical Outcome At the final evaluation, the wound had almost healed and was no longer probing to bone.
Treatment regime •
A detailed wound evaluation was completed at a baseline assessment and at 4 further scheduled study visits over a treatment period of 53 days
•
Tissue management: A mix of debridement methods were utilized. Sharp curettage of the ulcer bed with a ring curette (baseline, follow-up visits 1 - 3) and sharp debridement (follow-up visits 2 and 3) of the peri-wound were performed; at the final assessment debridement was not required (Figure 7)
52-year-old male •
50
Acutely infected diabetes-related foot ulcer (DFU), secondary to peripheral neuropathy and poor footwear
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Ex-intravenous drug user, on Methadone program
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Type I Diabetes Mellitus, Hypertension, and Ischaemic Heart Disease, Peripheral Arterial Disease and Peripheral Neuropathy
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12 months prior to presentation, the patient had undergone amputation of the right fourth toe
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The DFU, located on the plantar 1st metatarsal head on the left foot, measured 7.8 cm2 (area) with a depth ranging from 0 to 0.2 cm. The ulcer duration at presentation was 4 weeks
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Tissue management: The wound bed was composed of 9% slough and 91% hypergranulating tissue (as per 3D wound imaging software)
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Infection control: There were clinical signs of a mild skin and soft tissue infection
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Figure 7a: Start of evaluation (day 1). A 4-week-old diabetic foot ulcer with high levels of yellow/ green, viscous exudate. The peri-wound skin was hyperkeratotic and callus was visible. Figure 7b: Treatment day 20. After 20 days of treatment, the wound area had reduced by 30.8% to 5.4 cm2, with an average depth of 0.1 cm. Exudation had reduced to moderate. Figure 7c: Treatment day 27. After 27 days of treatment, the wound area measured 3.5 cm2 (a 55.1% reduction) with no wound depth. The wound bed was composed of 99% granulating tissue and 1% slough. 7a
7b
7c
How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide
Figure 7d: Treatment day 42. Wound area measured 1.9 cm2, a 75.6% reduction from baseline. Wound exudate remained moderate but was clear/ serous and non-viscous in appearance. Figure 7e: End of evaluation (day 53). At the final follow-up visit, the area of the wound had reduced by 83.3% to 1.3 cm2. 7d
treatment, only mild wound malodor remained. At the final assessment, the wound was free from clinical infection and on a healing trajectory •
Moisture management: After 20 days of treatment, the level of wound exudate decreased to a moderate amount. Over the next 22 days and until the end of the study, the exudate transformed into a non-viscous and clear/ serous appearance. At the final assessment, the exudation was minimal. Throughout the study, the skin surrounding the wound remained healthy. Additionally, the patient did not experience any pain during dressing changes throughout the entire duration of the study
•
Clinical outcome: The primary management approach for this patient focused on source control. This involved debridement to physically eliminate infected tissues, along with the use of topical antimicrobial therapy as an additional measure to reduce overall bioburden. Adequate fluid management was necessary due to the high exudate level. At the final assessment, the wound showed significant improvement and was progressing towards healing, indicating successful achievement of source control
7e
•
•
•
At all dressing changes, the wound was cleansed with Granudacyn® (wound irrigation solution containing hypochlorous acid) Infection control: At baseline, the wound was dressed with Exufiber® Ag+ (silvercontaining gelling fibre dressing; primary dressing) and Mextra® Superabsorbent (superabsorbent; secondary dressing (Mölnlycke, Gothenburg, Sweden)). After 20 days, as wound exudation had reduced, the secondary dressing was replaced with Mepilex® Border Flex (foam dressing). Throughout the study, Mefix® (adhesive dressing) was used for dressing fixation, 2-layer Tubigrip® E (elasticated tubular bandage, Mölnlycke, Gothenburg, Sweden) provided compression therapy and a CAM walker was used for offloading Dressings were changed at each study assessment and, in between these visits, the patient changed the dressings as per clinician request
•
Follow-up assessments: After 53 days of treatment, the wound area had reduced by 83.3% to 1.3 cm2, with no depth
•
Tissue management: The composition of the wound bed tissue gradually improved over the study period, and after 42 days of treatment, was composed of 100% granulation tissue
Conclusion M.O.I.S.T. offers clinicians a framework to help support them in making good clinical decisions when managing patients with wounds. The real benefits of M.O.I.S.T. are more easily explained when the model is used in clinical practice. The case studies above illustrate the benefits of using a platform such as M.O.I.S.T. to help with the assessment and treatment of patients with chronic wounds. By providing a methodical walk through the patient journey, M.O.I.S.T. can be used to help identify problem areas and encourage clinicians to consider the main wound related issues, and combined with holistic patient assessment it can provide a useful platform for the promotion of wound healing.
References •
Infection control: The clinical signs of wound infection had resolved following 3 weeks of antibiotic therapy and local wound management. After 42 days of
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How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide 3. Brown A. The role of debridement in the healing process. PubMed. 2013 Dec 24;109(40):16–9. 4. Schultz GS , Barillo DJ , Mozingo D W et al. Wound bed preparation and a brief history of TIME. International Wound Journal. 2004 Apr;1(1):44–5. 5. Dissemond J, Assenheimer B, Engels P, et al. M.O.I.S.T. - a concept for the topical treatment of chronic wounds. J Dtsch Dermatol Ges. 2017;15(4):443-445. 6. Winter GD. Formation of the Scab and the Rate of Epithelization of Superficial Wounds in the Skin of the Young Domestic Pig. Nature [Internet]. 1962 Jan;193(4812):293–4. Available from: https://www.nature.com/articles/193293a0 7. Heyer K, Augustin M, Protz K, Herberger K, Spehr C, Rustenbach SJ. Effectiveness of Advanced versus Conventional Wound Dressings on Healing of Chronic Wounds: Systematic Review and Meta-Analysis. Dermatology. 2013;226(2):172–84. 8. Dissemond J, Augustin M, Eming SA, Goerge T, Horn T, Karrer S, et al. Modern wound care - practical aspects of non-interventional topical treatment of patients with chronic wounds. JDDG: Journal der Deutschen Dermatologischen Gesellschaft. 2014 May 12;12(7):541–54. 9. Wound exudate and the role of dressings: a WUWHS consensus document - Wounds International [Internet]. 2007. Available from: https://woundsinternational.com/consensus-documents/read-more-wound-exudate-and-role-dressingswuwhs-consensus-document-2/ 10. WUWHS Consensus Document - Wound Exudate, effective assessment and management - Wounds International [Internet]. 2019. Available from: https://woundsinternational.com/world-union-resources/wuwhs-consensus-documentwound-exudate-effective-assessment-and-management/ 11. Hu J, Guo S, Hu H, Sun J. Systematic review of the efficacy of topical haemoglobin therapy for wound healing. International Wound Journal. 2020 May 19;17(5):1323–30. 12. Hauser CJ. Tissue Salvage by Mapping of Skin Surface Transcutaneous Oxygen Tension Index. Archives of Surgery. 1987 Oct 1;122(10):1128. 13. Addressing complexities in the management of venous leg ulcers - Wounds UK [Internet]. 2019. Available from: https:// wounds-uk.com/best-practice-statements/addressing-complexities-management-venous-leg-ulcers/
14. Gottrup F, Dissemond J, Baines C, Frykberg R, Jensen PØ, Kot J, et al. Use of Oxygen Therapies in Wound Healing. Journal of Wound Care. 2017 May;26(Sup5):S1–43. 15. Arenberger P, Engels P, Arenbergerova M, et al. Clinical results of the application of a hemoglobin spray to promote healing of chronic wounds. GMS Krankenhhyg Interdiszip. 2011;6(1):Doc05. 16. Swanson T, Grothier L, Schultz G. Wound Infection Made Easy - Wounds International [Internet]. 2015. Available from: https://woundsinternational.com/made-easy/wound-infection-made-easy/ 17. Malone M, Schwarzer S, Radzieta M, Jeffries T, Walsh A, Dickson HG, et al. Effect on total microbial load and community composition with two vs six‐week topical Cadexomer Iodine for treating chronic biofilm infections in diabetic foot ulcers. International Wound Journal. 2019 Sep 5;16(6):1477–86. 18. Dissemond J, Strohal R, Mastronicola D, Senneville E, Moisan C, Edward-Jones V, et al. Therapeutic Index for Local Infections score validity: a retrospective European analysis. Journal of Wound Care. 2020 Dec 2;29(12):726–34. 19. Bjarnsholt T, Eberlein T, Malone M, Schultz G. Management of wound biofilm Made Easy - Wounds International [Internet]. 2017. Available from: https://woundsinternational.com/made-easy/management-of-wound-biofilm-made-easy/ 20. Bjarnsholt T, Buhlin K, Dufrêne YF, Gomelsky M, Moroni A, Ramstedt M, et al. Biofilm formation - what we can learn from recent developments. Journal of Internal Medicine [Internet]. 2018 Jul 9 [cited 2019 Jul 17];284(4):332–45. Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/joim.12782 21. Trengove NJ, Bielefeldt-Ohmann H, Stacey MC. Mitogenic activity and cytokine levels in non-healing and healing chronic leg ulcers. Wound Repair and Regeneration. 2001 Dec 25;8(1):13–25. 22. Percival SL, McCarty S, Hunt JA, Woods EJ. The effects of pH on wound healing, biofilms, and antimicrobial efficacy. Wound Repair Regen. 2014;22(2):174-186. 23. Strohal R, Dissemond J, Jordan O’Brien J, Piaggesi A, Rimdeika R, Young T, et al. EWMA Document: Debridement: An updated overview and clarification of the principle role of debridement. Journal of Wound Care [Internet]. 2013 Feb [cited 2019 Dec 20];22(Sup1):S1–49. Available from: https://ewma.org/fileadmin/user_upload/EWMA.org/Project_Portfolio/ EWMA_Documents/EWMA_Debridement_Document_JWCfinal.pdf 24. Bahr S, Mustafi N, Hättig P, et al. Clinical efficacy of a new monofilament fibre-containing wound debridement product. J Wound Care. 2011;20(5):242-248.
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Masterclass GUIDES Introduction This guide introduces M.O.I.S.T. wound care integration, boosting practitioner confidence in independent decisions for treating chronic wounds. It enhances care through patient-centered planning, oxygen integration, and collagen synthesis for faster healing and reduced pain.
What is M.O.I.S.T.?
M.O.I.S.T. Wound Education Model Keywords ■ M.O.I.S.T. Concept ■ Chronic Wounds ■ Wound Education Model ■ Wound Care ■ Moisture Balance
■ Oxygen Balance ■ Infection Control ■ Support ■ Tissue Management
Figure 1:
■ The concept is intended to provide healthcare
professionals with guidance for systematic planning and education regarding the local therapy of patients with chronic wounds1
■ Acts as a reference tool that enables wound care
specialists to enhance treatment efficacy and confidence
■ Integrating supportive therapies like compression and off-loading, the M.O.I.S.T. approach ensures a holistic treatment approach
■ Flexibility in factor evaluation tailors treatment to
individual patient needs, ensuring personalized care and optimized outcomes
■ Empowers specialists to design personalized treatment
plans, enhancing healing and overall wound management
Wound Education Model
How Has It Been Developed? ■ In order to better structure the multitude of wound products, the M.O.I.S.T. concept was developed by a multidisciplinary expert group of WundDACH, the umbrella organization of German-speaking professional societies1
■ It expands upon the existing wound care best practices,
building upon the well-established TIME wound assessment protocol
■ The expanded framework adds oxygen and the crucial
restoration of optimal oxygen balance in wounds, enabling innovative therapies to recalibrate conditions for enhanced healing
Who Is It For? ■ Provides a balanced and structured approach for addressing diverse types of chronic wounds in various patients. It is intended for all wound care specialists and generalists responsible for patients with chronic wounds
■ Puts patients at the center of their care journey by guiding
clinicians and caregivers to consider the comprehensive spectrum of factors influencing their wound healing process
■ Incorporates current clinical best practices, offering healthcare practitioners a unified framework to enhance care consistency and optimize patient outcomes
■ Promotes evidence-based treatment protocols and facilitates
more effective product selections within the healthcare system
■ The successful therapy of chronic wounds is then based on
the causal treatment of the underlying, pathophysiological relevant diseases2
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Masterclass GUIDES
M.O.I.S.T. Wound Education Model
Moisture Balance: How can we help ensure that a wound isn’t too wet or too dry?
■ A wound’s inability to heal can result from either
excessive dryness or excessive moisture. Thus, it becomes imperative to achieve a balance of moisture within the wound for effective healing
■ There is a range of dressings which preserve moisture level or absorb excessive exudate to reach moisture balance
Treatment options include:
■ Wound gels to add moisture ■ Alginates, hydrofibers, foams and superabsorbers absorb exudate and other fluids
Oxygen Balance: How can we restore oxygen to a wound so it can heal?
■ Oxygen plays a pivotal role in the body’s metabolic
processes, including the intricate mechanisms of wound healing. Deficiency in oxygen can significantly impede the progress of numerous chronic wounds
■ Restoring oxygen to the correct level is a critical
Treatment options include:
■ Haemoglobin spray, hyperbaric or normobaric oxygenation
element to support all phases of healing
Infection Control: How can we manage the risk of infection in chronic wounds
■ Infection poses an ever-present and significant threat to chronic wounds, inducing pain, discomfort, and potential delays in healing that may necessitate hospital readmission
■ Continuous watchfulness aids in infection
prevention, and timely intervention can halt potential complications. Multi-resistant pathogens can be eliminated and local infections managed with topical antiseptics or antimicrobial dressings
Treatment options include:
■ Wound gels to add moisture ■ Alginates, hydrofibers, foams and superabsorbers absorb exudate and other fluids
Support: How can we support and stimulate healing in hard-to-heal wounds?
■ When problematic wounds are treated but do not heal as expected, strategies to rebalance the environment inside the wound bed can get healing back on track3
A range of therapeutic and treatment choices are available to stimulate healing:
■ Control and bind excessive MMPs, optimise pH
conditions, protect growth factors, control proinflammatory mediators, collagen dressings
Tissue Management: What are best practices in cleaning and preparing the wound bed?
■ Maintaining a healthy wound bed is crucial for
healing. This involves cleansing and preparing the area, removing dead cells and tissue through diverse debridement techniques
■ Specialised dressings or physical therapies like
negative pressure wound therapy (NPWT), electrical stimulation or ultrasound can enhance the effects of debridement
Treatment options include:
■ Cleanse the wound with normal saline (9%); Ringer’s solution; preserved solution
■ Debride the wound through autolytic, biosurgical, surgical, enzymatic and mechanical methods and therapies
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Masterclass GUIDES
M.O.I.S.T. Wound Education Model
What Is the Evidence? M.O.I.S.T.’s efficacy, cost-effectiveness, and infection control have been validated through trials. They have gained significant popularity because of their ability to create an optimal environment for wound recovery.4 It accelerates recovery, reducing complications and costs. Early M.O.I.S.T. concept intervention prevents chronic wounds, leading to expedited healing, reduced pain, and potential savings. This technique enhances mobility, circulation, and protein efficacy, thereby minimizing the risk of infection. In turn, this bolsters patient satisfaction and enhances outcomes.
Efficacy ■ Moist wound healing stimulates fibroblasts to
synthesize collagen. Since collagen is crucial for new tissue formation and wound healing, this heightened production expedites the body’s creation of a framework for new tissue, thereby attracting the necessary healing cells
Pain ■ A moist wound environment reduces the possibility of infection
■ Moist wound healing environments are hypoxic.
This nature is generally unconducive to the growth of harmful infectious agents. Moreover, hypoxia promotes the formation of new blood vessels and improves tissue perfusion required for adequate healing6
■ Moist wound healing stimulates fibroblasts to
synthesize collagen, a pivotal component in new tissue formation and wound healing. This heightened collagen production accelerates the creation of a framework for new tissue, facilitating the attraction of essential healing cells
■ Preserves growth factors in wound fluid,
they are proteins which control key cellular activities during the tissue repair process. This preservation of growth factors on the wound bed within a moist environment expedites tissue repair, fostering accelerated healing
■ By promoting the growth and movement of new
cells and ensuring that proteins for closing the wound are efficient, causes reduced inflammation, promotes more even skin formation and therefore reduces scarring5
■ A good nutritional status is also an essential part of the care of patients with wounds in order to promote healing, and the management of pain should also be considered in the patients’ care
■ Therapies that target specific pro-inflammatory
mediators or modulate the inflammatory cascade can help regulate the inflammatory response and create a more favorable environment for healing
■ Many wound dressings now exist which can help
■ Controlling MMPs, optimizing pH conditions,
protecting growth factors, controlling proinflammatory mediators, and utilizing collagen dressings, work together to rebalance the wound environment and promote the healing process
■ By addressing specific factors that may be
inhibiting healing, these strategies can help get the healing of problematic wounds back on track and improve overall patient outcomes
to support the optimal moisture balance within the wound bed, some of which contain a silicon wound contact layer which not only promotes healing but facilitates pain reduction on dressing removal
Debridement ■ A healthy wound bed is crucial for effective wound
healing; in order to create an optimal environment for healing, it is necessary to clean and prepare the wound bed by removing any dead cells and tissue. This process, known as debridement, can be achieved through various methods depending on the nature and condition of the wound
■ By promoting collagen synthesis and creating an
optimal wound healing environment, the M.O.I.S.T. concept wound education model can expedite the healing process. This results leads to shortened treatment periods and decreased associated costs
■ Fewer complications arise from establishing an
environment that minimizes infection risks and necessitates fewer dressing changes. By averting complications and employing suitable moistureretentive dressings, less frequent alteration is required. As a result, moist wound healing dressings showed a cost reduction, compared to traditional dressings7
■ The prevention of chronic wounds is achieved by
prioritizing early intervention and appropriate wound management techniques. Effectively treating wounds during their initial stages can help stave off the development of chronic wounds, which are more challenging and costly to address
■ Patient outcomes are enhanced through faster
healing and reduced pain. This translates to shorter hospital stays, lower readmission rates, and increased patient satisfaction, all contributing to potential cost savings
■ When faced with a wound infection, it is important
to act quickly to reduce the levels of bacteria and to prevent spread locally and systemically. This is best achieved by physical removal of non-viable or infected tissue such as debridement, and effective and repeated cleansing of the wound and periwound skin using a safe antiseptic cleansing solution (for example, polihexanide or hypochlorous acid)
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M.O.I.S.T. Wound Education Model
Masterclass GUIDES
Key Points
■ The M.O.I.S.T. concept stands for Moisture balance, Oxygen balance, Infection control, Support, and Tissue management ■ Serves as an actionable reference tool for wound care specialists ■ Reduces pain and stress, which enhances patient mobility, circulation, and overall healing ■ Prevents infections and fosters angiogenesis while inhibiting bacteria ■ Healing is accelerated through collagen synthesis, reducing treatment duration and costs ■ Chronic wounds are prevented through early intervention and proper management
References 1. Dissemond J, Assenheimer B, Gerber V, et al. Lokaltherapie chronischer Wunden: Das M.O.I.S.T. Konzept [M.O.I.S.T. concept for the local therapy of chronic wounds]. Dtsch Med Wochenschr. 2023;148(7):400-405. doi:10.1055/a-1987-4999 2. Dissemond J, Bültemann A, Gerber V, Jäger B, Kröger K, Münter C. Diagnosis and treatment of chronic wounds: current standards of Germany’s Initiative for Chronic Wounds e. V. J Wound Care. 2017;26(12):727-732. doi:10.12968/jowc.2017.26.12.727 3. M.O.I.S.T. educational platform | Mölnlycke | Mölnlycke Advantage [Internet]. www.molnlycke.com. Available from: https://www.molnlycke.com/education/wound-areas/ moist/ 4. Liang Z, Lai P, Zhang J, Lai Q, He L. Impact of moist wound dressing on wound healing time: A meta-analysis [published online ahead of print, 2023 Jul 19]. Int Wound J. 2023;10.1111/iwj.14319. doi:10.1111/iwj.14319 5. Wound Source. The Benefits of Moist Wound Healing [Internet]. WoundSource. 2016. Available from: https://www.woundsource.com/blog/benefits-moist-wound-healing 6. The Benefits of a Moist Wound Healing Environment [Internet]. 2023 [cited 2023 Aug 17]. Available from: https://www.thewoundpros.com/post/the-benefits-of-a-moist-wound-healing-environment#:~:text=Reduced%20Likelihood%20of%20Wound%20Infection,perfusion%20required%20for%20adequate%20healing. 7. Schmitz M, Eberlein T, Andriessen A. Wound treatment costs comparing a bio-cellulose dressing with moist wound healing dressings and conventional dressings. Wound Medicine. 2014;6:11–4. doi:10.1016/j.wndm.2014.07.002
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Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass Moderator Miss Negin Shamsian Consultant Plastic and Reconstructive Surgeon (Locum) London, United Kingdom
So, What is Biofilm? Biofilm is defined as one of the oldest lifeforms on Earth and is something developed by bacterial organisms. It is only within the last 40 years that Biofilm has been given this name in Science and Medicine; and it is the natural and predominant
Introduction
way that bacteria live and thrive. Bacteria will attach
I
themselves to a surface, which can either be liquid or mmersive Interactive Event; Taking wound care
solid, and once they’re securely attached, they secrete
into a new dimension. Hosted by Dr N. Shamsian
a polymeric matrix around themselves – This is what
in partnership with Dr M. Sanders and Dr P Bowler.
we call Biofilm. Biofilm acts as a protective layer that
Bowler has an extensive history and career within
defends the bacterial organism from hostilities within the environment or hosted organism.
wound care development and research with over
Supported by
30 years of experience in microbiology, particularly
This Biofilm layer contains exopolysaccharides – high-
focused on infections. He has been involved in the
molecular-weight polymers that are composed of
development of wound dressings alongside various
sugar residues and are secreted by a microorganism
independent consultants. Sanders has worked for
into the surrounding environment – DNA and RNA.
a diagnostic wound care company that developed
Both DNA and RNA are almost identical, are used
diagnostics for bacterial status that was sold back into
to store genetic information, but they have differing
the wound-check business. After 16 years working
base pairs and can be found in various places of the
with the company, he joined a consulting firm where
cell, but mostly within the nucleus. Due to this nature
he expanded this experimental field by developing
and structure of the Biofilm, it is easy for them to
numerous products for wound care and targeted the
adapt by altering or changing their phenotype and
anti-inflammatory stages, and infection whilst also
genotype for survival. This presents a challenge in
maintaining an interest in the fields of cancer and
the microbiology world of Science and Medicine as
brain injury through studying neuroinflammatory
it means antibiotics are ineffective in the treatment
processes. He now works in partnership with the
of bacterial infections that include such complex
consulting firm ProDevLabs who are supporting the
structures.
event discussed today.
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Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass
“Biofilm is inextricably linked to chronic infections, leading to delayed healing and recurrence. This requires tailored treatment for wound care.” Dr M. Sanders
Treatment: Antibiotics and Initial Stages
no mention of Biofilm; during this time, Science and Medicine were aware of the existence but unsure of
Antibiotics and antiseptics are mostly ineffective
the capabilities, adaptability and extensive nature of
against Biofilm due to this shifting nature and structure
the bacteria.
that Biofilm possess, meaning the inflammatory response within a wound is increased. At this stage,
At What Point Does the Wound Become Critical
it is integral and crucial that debridement and the
During This Colonisation?
washing of the wound is used as an intervention to discover the depth and nature of the inflammatory
When we consider the critical nature of a wound, it is
process.
important to consider the comorbidities and health of the patient overall. This staging of ‘critical’ will differ
How Does the Biofilm Trigger the Inflammatory
from patient to patient, and there is no set timeframe.
Response?
Essentially, this will be when the host is no longer able to control the microbial contamination, therefore
When the Biofilm hijacks the hosts skin/wound,
requiring
additional
and
interventive
microbial
neutrophils attempt to discover the parasite or
support to manage the wound and return control to
bacterial infection where they undergo an oxidated
the host.
burst. The Biofilm itself is tolerant to the immune cells and attracts them towards the bacteria where they
Bowler states that he would not use this term
spill enzymes into the surrounding environment that
in modern society and the world of Science and
damage the hosts tissue further, which is why we can
Medicine as it has been superseded by the Biofilm
almost consider Biofilm to be a parasitic infection.
Continuum. Bacteria initially starts as a planktonic cell
As this tissue devitalises, it provides more tissue
on the surface, mostly a wound, where they attach
for the Biofilm to consume and continue to spread.
themselves and adapt rapidly. As the Biofilm layer is
Elimination of the Biofilm at this stage becomes
produced, this is the continuum; the process by which
crucial to prevent further inflammatory response and
the wound becomes colonised.
infection spread, whether this is through physical intervention, antimicrobial or new strategies within
Randy Walker, a pioneer in the field of Science and
wound care.
Medicine, recently spoke about ‘When does a wound become chronic? Does this take 30 days or longer?’
Bowler very clearly agrees that all chronic wounds
The problem with this question is that Biofilm can
have a Biofilm element due to their nature being so
quicken the process, and a wound can easily turn
disruptive and the response to antibiotic treatment.
chronic within a matter of days. Walker acknowledges
As the antibiotics are ineffective and the persistence
this and takes the approach that; if there are warning
of chronic wounds prevails, there is clear evidence
signs there, effectively treat in the early stages.
that a Biofilm layer is preventing efficient healing.
This will minimise the chance of chronic wounds,
The impact of Biofilm on the healing stages is vast
inflammation and the need for further intervention
and includes, but it not limited to; delayed healing
through new strategies and emerging technologies.
response, chronic wounds, recurrent infections, delayed closure, and impaired blood vessel formation.
Challenges: What Do Professionals Face When Treating Biofilm?
Critical Colonisation is a term that was used for around 25 years and refers to the stage when
Some of the challenges that consultants and working
bacteria colonise a wound to cause further infection
professionals face when treating wounds, those
and increased challenge to treatment. When this
that have this Biofilm layer, is the microscopic and
term was first penned by professionals, there was
hidden nature of the Biofilm itself, the variable
© Copyright. Wound Masterclass. 2023
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Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass
“We need a Multifactorial Blockade to healing.” Dr N. Shamsian
composition of the bacteria, sampling techniques
For immunocompromised individuals, Pseudomonas
for definitive diagnosis, laboratory techniques to
Aerginosa is a major issue as it is multi-antibiotic
extract the DNA, dynamic nature of the wound, false-
resistant and this reduces the effectiveness of
negative results and the final clinical interpretation.
treatment so further treatment and combination
From the initial stage of seeing the wound, to the
therapies must be considered.
final stage of diagnoses there are clear barriers and challenges that need to be considered. There are also
New Treatment and Strategies
further factors to consider, like the comorbidities of patients, particularly those with Diabetes or Venous
Dr Bowler and Dr Christine Murphy, specialist from
insufficiency as this can cause further issues when
Ottawa, Canada, have penned the term Granulitisas
determining the nature of the wound; and whether
the induced hyperinflammatory process of Biofilm.
the wound does have a Biofilm component.
Although developing technologies are helping to identify the nature of the wound, it is crucial to
Accurate diagnosis is vital for effective treatment of
start effective treatment and reduce the risk of
the wound as we can guide our targeted antimicrobial
occurrence of Granulitis. This treatment can include
selection for patients, and it allows room for
Photodynamic Therapy, Quorom Sensing Inhibitors,
combination therapy where appropriate. Consultants
Biofilm Disputing Enzymes, Nanoparticle based
can be more informed of the optimal wound
approaches,
management and strategies to reduce the risk of
Systems, Electrochemical Treatments, Antibiofilm
recurrence, whilst optimising the resource utilisation
Surfaces and Coatings, Biofilm Imaging Techniques,
and improving the overall treatment outcome.
Combination Therapies and Vaccines.
Some examples of specific microorganisms include:
Bowler mentions that they have been developing a
Biofilm-responsive
Drug
Delivery
3-Dimensional printing method to copy Biofilm, or •
Staphylococcusaureus
a collagen substrate, to assess antibiofilm agents in
•
Pseudomonasaeruginosa
vitro. By implanting the genetically contained and
•
Escherichia coli
grown organisms, they have transplanted this onto
•
Streptococcus species
animals for experimentation and testing. These
•
Fungi
models prove vital for representing the stages
•
Viruses specifically
and demand of resistance that we see on humans’
•
Bacteriophages
wounds. These clinical models are invasive and
•
Protozoa such as acanthamoeba and naegleria
hard to remove, and professionals find themselves
species
using fine and sharp debridement as a method for removing and disrupting Biofilm, enhancing the
And some further examples of microorganisms that
importance of an imaging device to see the definitive
we know leave Biofilm in wounds include:
nature of a wound. By using this strategy, we can visualise the location of the Biofilm and target directly with treatment.
•
Staphylococcus aureus
•
Pseudomonas aeruginosa
•
Escherichia coli
•
Candida Albicans
•
Proteus Mirabilia’s
Using a Cellink 3D BioX Printer to print methacrylate
•
Enterococcus Faecalis
collagen
3-D Printed Biofilms
loaded
aeruginosaor
with
either
Staphylococcus
GFP-Pseudomonas aureus
and
then
photo-activated the collagen with lithium phenyl-2, 4, 6-trimethylbenzoyl phosphonate (LAP) dye and
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Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass
““Infection diagnostics are difficult in the US due to the diagnostic stages and determining the Biofilm infection.” Dr M. Sanders
polymerised with a near UV-light source. An amber
Conclusion
syringe containing a suspension of 2mls of Lifelink 200 collagen and 250 jul of an overnight culture of
Sanders states that the two main aspects of Biofilm
each microbe was loaded into the printer in a dark
in relation to wound care is to; Prevent the formation
room to avoid premature curing of the collagen
at the initial stages; Disrupt and Destroy the Biofilm.
with ambient light. After printing all the layers of the
Enhanced treatment efficacy and a personalised
collagen-microbial disk, the UV light was utilised to
treatment approach are essential for reducing the
cure the 3D print.
risk of recurrence, prevention of chronic infection and the improvement of wound healing, which, results in
Following the printing, the Biofilm disks were exposed
patient quality of life and cost savings for Science and
to natural light for 30 minutes to allow for complete
Medicine.
curing and then incubated overnight at 37C. The disks were then incubated for another 24 hours in a proprietary Biofilm binding buffer and were either used immediately or stored in tryptic soy broth with 2% sucrose for lyophilisation followed by ambient storage at -80C for future use. In these trials for 3-D printing, Bowler also states that he has found some antimicrobials are effective at reducing the exopolysaccharide matrix and others
See all Wound Masterclass MasterSeries on demand: bigmarker.com/wound-masterclass
are good for destroying Biolase. Primarily, these are ineffective once the Biofilm has occurred and that is the reason for no further development of new antibiotics within the laboratory for treatment of wounds.
© Copyright. Wound Masterclass. 2023
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Global Innovation in Wound Care Summit Series What Do I Need to Know About Skin Substitutes? Moderator Miss Negin Shamsian Consultant Plastic and Reconstructive Surgeon (Locum) London, United Kingdom
requirements. Surgery and secondary healing is good, when a combined approach can occur, but the key question is when to use what. Dr N. Shamsian precedes to ask, ‘What is the most common type of wound you see?’, to which Devine responds that it is mostly chronic wounds; venous
Introduction
ulcers, lower extremity wounds, and sometimes
D
surgery from previous cancer treatment. The use r N. Shamsian is joined by North American
of skin substitution is vital as it can prevent further
expert Dr J. Lantis (Professor and Chief in
arduous surgical management and gives the clinician
Surgery), Associate Professor M. Wagstaff
options for preservation and treatment.
(Head of Plastics and Reconstructive Unit, Australia) and Dr M. Devine from Arizona (Plastics and
“How has microsurgical transfer to skin substitutes
Reconstructive Surgeon).
changed over the last 2 decades?”
Global expert
Due to the variety of options available for skin substitution, there is a lesser need for surgical
Dr Michael N. Desvigne
transfer, but rather more additional scaffolding with
Board-Certified Plastic Surgeon, General Surgeon, Hyperbaric physician, Wound Care Clinician
skin substitutes and the advantage of synergistic
Scottsdale AZ, United States
of experience, or expertise, is within the field of
substitution. Devine explains that his primary area placental-type products.
Supported by
The Use of Aseptically Processed Placental Allograft
Processing the material matters as you can achieve
and Meshed Reticular Acellular Dermal Matrix in
the same sterility as terminally sterilized tissue
Soft Tissue Reconstruction
which preserves tissue structure, matrix proteins and signaling cues. This provides a safe, quality
62
Dr M. Devine hosts the next segment of wound
tissue that is most like native autograft (human skin).
management as a Plastics and Reconstructive
Terminal sterilization alters tissue properties of the
surgeon based in Arizona. Devine notes that there are
native tissue by denaturing the structure and matrix
a lot of options for skin substitutes, and it depends
proteins, with a compromised binding site for cell
on the goal and customized approach of the patients’
attachment and signaling functions.
Wound Masterclass - Vol 2 - December 2023
© Copyright. Wound Masterclass. 2023
Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?
“The meshed HR-ADM had properties that allowed for tissue integration and incorporation with the soft tissue deficits benefitting particularly from the processed placental allograft.”
aseptically processed allograft included proliferation, We must consider an algorithmic approach to
angiogenic, and antimicrobial properties that were
placental allografts.
useful for wound healing and surgical reconstruction. The meshed HR-ADM had properties that allowed
•
Wound management; Cellular proliferation –
for tissue integration and incorporation with the
AmnioBand Membrane. Dermal replacement –
soft tissue deficits benefitting particularly from the
AlloPatch Pliable
processed placental allograft. The use of HR-ADM may aid in creating a scaffolding for tissue ingrowth,
•
•
Incisional management; Cellular proliferation –
later supporting flap transfer, as well as adequate soft
Salera mini membrane placental Allograft
tissue coverage.
Anticipating post-surgical complications; cellular
Global expert
proliferation – Salera mini membrane placental
Prof Marcus Wagstaff
Allograft. Dermal replacement and/or soft tissue
Plastic and Reconstructive Surgeon, Head of Unit of the Adult Burns Service at the Royal Adelaide Hospital (RAH)
scaffolding – SomaGen Meshed dermal matrix •
Optimizing
surgical
outcomes;
Adelaide, Australia
Cellular
proliferation – Salera mini membrane placental allograft. Dermal replacement and/or soft tissue scaffolding – SomaGen Meshed dermal matrix
NovoSorb BTM - Biodegradable Temporising Matrix
Some of the key benefits to Somagen is that it is the
In this next segment of wound management and
first of its kind (meshed reticular dermal allograft), is
skin substitution methods, we go to Prof M Wagstaff
ready to use that saves valuable operating theatre
(Associate and Desvigne Professor in Plastic Surgery,
time, pliable and conforms to anatomy, compatible
and the Head of Burns Unit Royal Adelaide Hospital,
with advanced wound care such as NPWT, it has
Australia). When BTM was being developed in 2011,
a versatile meshing ratio which allows clinicians
Wagstaff was part of the research team and overlooked
to address wounds on a much larger scale, and an
the first clinical trials with human patients, further
18-month shelf life at room temperature.
developing the products based on their findings and research. Synthetic skin substitutes include a variety
Case
Summary;
Multiple
pressure
ulcers.
66
of temporary and permanent examples, and the
y/o paraplegia secondary to transverse myelitis
ones we tend to think of are Bio-Brane (for epithelial
secondary to COVID. This patient developed multiple
coverage of superficial burns to prevent water loss),
pressure ulcers during prolonged hospitalization
and dermal substitutes that are a permanent implant
which progressed to the bone. The patient was
(BTM). Biodegradable Temporising Matrix is a 2mm
then admitted to hospital for acute infection and
bioabsorbable, biocompatible foam that consists of a
severity of ulcers, V.A.C VeraFlo therapy initiated
lower surface that allows for cellular infiltration and
with a cleanse choice dressing, taken to Operating
provides a scaffold for the dermis reconstruction,
Theatre for staged debridement and VeraFlo therapy,
with a sealing membrane over the top. This acts as a
SomaGen dermal matrix placed as tissue scaffold for
scaffold for granulation tissue to enter with a seal to
tissue replacement, Salera placental allograft placed
prevent tissue coalescing on the surface. It modifies
to optimize healing, Incisional V.A.C therapy initiated
the granulation and scar to form a dermal-like layer.
with PREVENA CUSTOMISABLE dressing immediately
Once the clinician has debrided the wound, it has a
following closure.
missing dermis that needs to be reconstructed. BTM can be draped over the wound like a garment,with
The summary of this situation concluded that an
© Copyright. Wound Masterclass. 2023
pieces
placed
in
opposition
(edge-to-edge)
Wound Masterclass - Vol 2 - December 2023
63
Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?
“The polymer in BTM doesn't get digested and therefore it can integrate if the fluid collections are drained and the infection treated using standard of care.”
and secured in place using staples or sutures. Over
Wagstaff continues to explain that the indications
a period of 2-5 weeks, depending on the age and
for using this approach would be in deep wounds
physiological state of the patient, the tissue grows
that are unable to support a skin graft (exposed
into the foam and integrates, as confirmed by
bones that have been drilled or burred to a point
capillary refill. The top layer can then be delaminated
of bleeding, exposed tendons, or exposed vital
by gently peeling off the sealing membrane. Once this
structures), wounds susceptible to graft contracture
layer has been removed, there is a nice bed for skin-
(across the joints and/or neck area), where there is
grafting to occur.
indication of an improved outcome in comparison to a skin flap (too bulky or local flaps unavailable), and if
Prof. Wagstaff explains that even during the early
the patient is unfit for a longer procedure.
outcomes of BTM treatment, the coverage of the skin was soft and robust in appearance and texture. There is a better reconstructive approach when
Global expert
initiating treatment with BTM, in comparison to
Dr John Lantis
simply debriding the wound before undertaking skin-
Chief and Professor of Surgery, Mount Sinai West Hospital and Icahn School of Medicine
grafting methods. There are 3 major ops for burns to consider:
New York NY, United States
1.
Day 0; Immediate excision
2.
Day 2-3; Re-excise and apply BTM to wound.
and Dr J. Lantis around his experience with skin
Simpler than grafting, less invasive and shorter
substitutes. Lantis is a leading expert in this field of
operation
wound care and Dr Shamsian begins the questioning
We now go to the discussion between Dr N. Shamsian
by asking specifically about what the potential biggest 3.
3-5 week cooling off period; graft when the
change over the last decade in clinical practice is.
patient is physiologically well and integrated,
Lantis responds to state there has been exponential
all superficial wounds healed means there is
growth in the number of substitutes available for
more donor site, patient is systemically stronger,
experts and clinicians to utilize in the hospital setting,
nutritional support, joints mobilized and there is
and an amplification in the media regarding patients
more reliable and faster donor site healing
being more aware of the products available; what is deemed the most beneficial and appropriate within
64
Wagstaff mentions that this approach means that
practice. Lantis further explains that there is an
burn management has been less tiring and stressful,
emphasis on experimenting with novel products more
and that the results are more reliable with the quality
arduously, hence the development and proliferation
of scarring improved. Dr N. Shamsian questions
of fish-skin substitution. Acellular fish-skin is now
whether the BTM can become infected, to which the
being considered a close substitute that Dr Shamsian
informed response is that BTM prevents dressing
classifies as a biological substitute, demonstrating
activity or physical cleansing to the wound site,
a closeness to human skin. Lantis explains that
so colonization or collections can occur. Wagstaff
fish-skin has an extracellular matrix coming from a
notes that this tends to happen around the second
xenograft and is a non-human source. The primary
week of treatment, however, BTM is like a petri dish;
mode of obtaining this type of substitute is through
the underlying tissue is agar, and that is not what
Icelandic Cod, through medical analysis, which has
becomes infected. The polymer in BTM doesn't get
a consistency of cells embedded within a network
digested and therefore it can integrate if the fluid
of non-living tissue; a likeness to that of human
collections are drained and the infection treated
skin. Lantis explains the overview of the product as
using standard of care.
follows; Acellular fish-skin for medical use patented
Wound Masterclass - Vol 2 - December 2023
© Copyright. Wound Masterclass. 2023
Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?
“Allografts can cause failure, if the skin graft is rejected by the host. Embryonic tissue has a dense barrier membrane with no cellular ingrowth, inhibiting the healing process and regeneration of tissue.”
by Kerecis. Fish-skin consists of cells embedded in
time and can either be a singular application or
a network of non-living cells (like human skin). CE
reapplied as a sequential depending on factors such
marked and FDA cleared. Manufactured with 100%
as physiological conditions of the patient. We can
renewable energy. Proteins and lipids are maintained
consider fish-skin to be a multiple-use product due
in their natural state. Decellularized and sterilized,
to this situation, where the single application can be
non-allergenic and biocompatible. Contains a biologic
carried out in the hospital setting, or at outpatients as
matrix, cells initially removed from the product itself.
a multiple-use product.
Lantis further explains that it is rare for people
Lantis further endeavors to state that there are four
to have an allergic or anaphylactic reaction to the
hallmarks of Kerecis Technology.
substitute as it is made from cod-skin (a fish), rather than produced from shellfish which is a common
1.
allergy in the modern age.
Natural structure
3-D
Structure
with
–
chemical
Instant
natural
complexity
is
immutable by synthesis or even the most Excluding the scales and DNA associated with fish,
advanced
engineering,
natural
tissue
specifically cod, the skin itself is identical to human
degeneration, rightpore size, chemicals and
skin and the benefit is that viruses in cold water fish
signals, fatty acid profile and tensile tissue
do not have utility within human bodies, therefore there is no risk of contamination of disease associated
2.
Natural Mechanical Properties – Strong and
with fish. The cells are removed using a gentle
preservers superior handling characteristics,
process, otherwise classified as ‘Patented Processing’.
handles like skin, pliable and easy to suture and
This removes the risk for a harsh viral inactivation
staple, surgeons favor this for ease and efficacy
process by a lack of transmission risk, and therefore
3.
Natural Molecular Content – Lipid rich biological
no strong alcohols, detergents, mechanical pressing,
barrier that protects against pathogens, limits
or tampering is needed. These factors have a major
irritation, and modulates tissue response with a
benefit on the cost-effectiveness at market value
chemical complexity of the fish skin promoting
with no crosslinking. All of the skin components are
rapid skin regrowth and neovascularization
Omega3 rich and provide proteins, glycans and fats that humans require to regenerate healthy layers of
4.
Natural Molecular Organization – Unique gentle
skin; encouraging the healing process. Lantis explains
processing, thousands of proteins, lipids and
that the graft is applied to human wounds where it
glycans are natively organized and mimic natural
recruits stem cells and regular cells to facilitate the
tissue ingrowth
tissue regeneration. Fish-skin is a robust substitute and can be combined When we compare fish-skin substitution to human
with mesh when applying to the surface of the wound.
allografts and embryonic tissue, there are differences.
Lantis explains that in this instance, it is better to affix
Allografts can cause failure, if the skin graft is rejected
the material with either staples or sutures for security
by the host. Embryonic tissue has a dense barrier
and a tactile approach that is less invasive or painful,
membrane with no cellular ingrowth, inhibiting the
essentially improving patient outcomes. Cod is a very
healing process and regeneration of tissue.
large fish so the sheets of fish-skin are essential for larger wounds. The molecular content breakdown
A key phrase of viewing the fish-skin like a dermal
is as follows; Collagen, Elastin, Laminin, Fibronectin,
scaffold
when
Proteoglycan, Glycols amino-glycans, Lipids (with
deliberating the effectiveness of technique and
Omega3). Alongside this beneficial structure, the
application. Lantis explains that the product itself
pore size of fish-skin is similar to human skin as well
modulates the wound bed, which can be seen over
as being very thick. Lantis goes on to explain ‘How
© Copyright. Wound Masterclass. 2023
is
an
essential
consideration
Wound Masterclass - Vol 2 - December 2023
65
Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?
“Some of the indicators for using fish skin would be diabetic foot wounds, venous leg ulcers, post-surgical wounds, burns, and skin-graft donor sites.”
To Use’ or ‘Best Practice’ when applying this as a
of Kerecis begin to adhere to the wound bed, they
substitute in 8 steps;
should be removed with a reapplication of new sheets if those have been partially absorbed or are no longer
1.
Remove necrotic tissue
visible. It is essential to change the wound dressing to maintain the moist environment.
2.
Remove exudate and control bleeding
3.
Remove the fish skin sheet from the pouch in an
temperature in a sterile packaging which will ensure
aseptic manner
a minimum of 2-year shelf life. It is important to note
The fish-skin itself should be stored at room
that they will be delivered in boxes of 10, which is 4.
Cut the sheet roughly to the size of the area to be
essential when managing patients that require a
covered
multiple-use purpose. Some of the indicators for using fish skin would be diabetic foot wounds, venous
5.
Pre-hydrate with NaCl solution
leg ulcers, post-surgical wounds, burns, and skin-graft donor sites.
6.
Apply sheet to wound, ensure no overlap of wound edges
A
double-blind,
randomized
clinical
trial
was
conducted on 162 wounds (81 patients) where one 7.
More than one sheet may be necessary for
wound was treated with Porcine and the other with
complete coverage. Overlap sheet edges to
Fish-skin as a substitute. The fish-skin demonstrated
ensure coverage
a significantly faster healing rate, and the same model was reproduced 5 years later with Fish-skin against
8.
Apply appropriate non-adherent wound dressing
Amnion/Chorion Products, which, again proved a
to maintain moist environment
significantly faster healing rate.
Dr N. Shamsian goes on to question ‘Are you doing
A study specifically for diabetic foot wounds where
something similar with this technique, and with a skin
Fish-skin was utilized vs. SOC (Standard of Care), once
cavity, are you overlapping the sides of the so the
again proved a faster healing rate. It is important to
defects are covered?’, to which Lantis responds with
consider that this study was conducted on significantly
a ‘Yes’. Allowing the wrap up to go around the size,
‘sicker’ patients with a preemptive comorbidity, in
even when you don’t have the right size substitute,
comparison to the previous 2 studies that were
with someone experienced in this area of treatment
conducted on younger and healthy individuals. The
you can morcellate or cut-up the product not to cover
wounds were harder to heal in the initial stages due
the entire wound, even though the preference is to
to this physiological condition, but again the efficacy
cover the entire area. Bu using deep quilting stiches,
was proven, and patients complained more about
we cauterize the defects that occur, and it is essential
pain and infection risk when utilizing the approach of
to keep this area moist as, if the area becomes dry,
SOC, in comparison to that of the fish-skin. Therefore,
the material may not stick to the wound, as described
we can deduce that fish-skin is more cost effective
by Lantis with the following anecdote: A fish does not
and improves overall patient outcomes.
like to be out of water. There are wounds that fish skin would not be Follow-Up
appropriate to use as a form of management and/or treatment, and this includes (but is not
66
Inspect the wound every 2-3 days depending on the
limited too); Acutely infected wounds (cellulitis),
amount of exudate, followed by cleaning the wound
over untreated osteomyelitis (bone infections not
areas as needed. If the previously applied sheets
previously treated), or directly over anastomosis.
Wound Masterclass - Vol 2 - December 2023
© Copyright. Wound Masterclass. 2023
Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes? Lantis gives the audience some helpful tips and tricks
every patient is the same. Product ‘X’ may be used
when considering the utilization of fish skin substitution:
for a period, then we move to a combined approach
Cut to size once the substitute is dry. Fenestrate
with fish- skin substitution, then we may add human
when wet.Suture whenever possible (Chromic suture
skin. There is no scope for layering the methodology
are best applicable). You can sew to the base of the
as of the moment, Lantis explains, but having this
wound. Keep the area hydrated (cover with Hydrogel).
combined approach to treatment may improve the
Finally, Dr N. Shamsian concludes by questioning ‘In
healing response. Even though there are new biologic
terms of the future for skin substitutions, what will the
and non-biologic products being adapted and tested
next stage be?’ and Lantis explains that essentially,
all the time, the future is uncertain without the
we need better algorithms as clinicians. We need
essential need for an algorithm that is informed and
to look at wounds with the understanding that not
based on specifics like disease or wound type.
Supported by
© Copyright. Wound Masterclass. 2023
Wound Masterclass - Vol 2 - December 2023
67
Biodegradable Temporising Matrix
For the reconstruction of diabetic foot wounds and venous leg ulcers. BTM supports cellular migration and formation of neodermis.1, 2 It provides a porous framework that bioabsorbs, leaving a robust vascularized dermal layer.3 A temporary sealing membrane protects the wound while the body heals.4
Infected Diabetic Foot Ulcer
Wound prior to debridement
Follow up at 4 months post grafting
Discover more at: polynovo.com
Refer to the Instructions For Use for full device details. References: 1. Greenwood JE, Schmitt BJ, Wagstaff MJD. Experience with a synthetic bilayer Biodegradable Temporising Matrix in significant burn injury. Burns Open. 2018;2(1):17-34. 2. Wagstaff MJD, Salna IM, Caplash Y, Greenwood JE. Biodegradable Temporising Matrix (BTM) for the reconstruction of defects following serial debridement for necrotising fasciitis: A case series. Burns Open. 2019; 3:12–30. 6. Data on file. 3. Wagstaff MJD, Schmitt BJ, Coghlan P, Finkemeyer JP, Caplash Y, Greenwood JE. A biodegradable polyurethane dermal matrix in reconstruction of free flap donor sites: a pilot study. ePlasty 2015; 15:102–18. 4. Greenwood JE, Dearman BL. Split-skin graft application over an integrating, biodegradable temporising polymer matrix: immediate and delayed. J Burn Care Res 2012; 33(1):7–19. ® PolyNovo and NovoSorb are registered trademarks of PolyNovo Biomaterials Pty Ltd.
woundmasterclass.com/Podcast
MasterSeries 60 Minutes Interactive Clinical Challenges and Solutions in Palliative Wound Management
Global expert Prof Georgina Gethin Professor of Nursing, Head of School of Nursing and Midwifery, University of Galway
serious health related suffering (SHS). This has been divided into two areas: •
with illness or injury of any kind
Galway, Ireland
•
Defining the Concept Of Palliative Wound Care
Suffering is health-related when it is associated
Suffering is serious when it cannot be relieved without medical intervention and when it compromises physical, social or emotional functioning
The World Health Organisation (WHO) defines palliative care as “an approach that improves the
Palliative care should be focused on relieving the SHS
quality of life of patients and their families facing
that is associated with life-limiting or life-threatening
the problems associated with life-threatening illness
conditions or the end of life. This illustrates how
through the prevention and relief of suffering
palliative care is not confined solely to end of life care,
by means of early identification and impeccable
but it goes beyond the spectrum; this is important for
assessment and treatment of pain and other
understanding palliative wound care.
problems, physical, psychosocial, and spiritual”. This is a very comprehensive definition, but as with many
The Lancet Commission recommends that the
other things, it is not without its critics.
definition be reviewed and revised to encompass health-system advances and low-income settings
The Lancet Commissions looked at palliative care, as
where medical professionals often have the difficult
well as WHO’s definition. In their publication they
task of caring for patients without necessary
looked at “Alleviating the access abyss in palliative
medicines, equipment, or training.
care and pain relief – an imperative of universal health
Supported by
coverage”.1 The document highlights the severe lack
The commission recommends a definition that
of access to healthcare that people in different parts
explicitly rejects any time or prognostic limitation on
of the world experience. An example of this includes
access to palliative care, includes complex chronic
how morphine for pain relief is inaccessible for
or acute, life- threatening, or life-limiting health
thousands of people.
conditions, and considers all levels of the healthcare system from primary to specialised care and all
70
The commission developed a new conceptual
settings where palliative care can be delivered. Thus,
framework for measuring the global burden of
the commission treats palliative care as an essential
Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management
“The commission treats palliative care as an essential component of comprehensive care for persons with complex chronic or acute, life-threatening, or life-limiting health conditions that should be practised by all healthcare and social care providers and by palliative care specialists, and that can be provided in any health-care setting, including patients’ own homes.”
component of comprehensive care for persons with
Their final definition concluded that palliative care is
complex chronic or acute, life-threatening, or life-
the active holistic care of individuals across all ages
limiting health conditions that should be practised
with serious health-related suffering due to severe
by all healthcare and social care providers and by
illness and especially of those near the end of life. It
palliative care specialists, and that can be provided
aims to improve the quality of life of patients, their
in any health-care setting, including patients’ own
families and their caregivers.
homes. Further research sought to carry this definition over Following these findings, a new document was
into the field of palliative wound care. One particular
created with the aims of redefining palliative care, and
paper carried out a Q methodology to look at how
most importantly this new definition was consensus
nurses frame palliative wound care.3
based.2 This was led by the International Association for Hospice & Palliative Care. The process involved
This links back to an earlier point regarding how
in creating this new consensus based definition is
important it is to have a concept or definition which
important to note, considering how critical it is to
therefore reduces, or at the very least minimizes,
understand who the thinkers behind something
this subjective notion of what is and is not palliative
are. Critical to their work, they used a three-phased
wound care, and who receives treatment from
consensus process involving healthcare professionals
various specialists and who does not.
from countries in all income levels: A common trait shared by all 4 Q-factors is the •
Phase 1: 38 Palliative care experts evaluated
perception of palliative wound care as an approach to
the components of the WHO definition and
improving the quality of life of end-of-life patients that
suggested new/revised ones
includes holistic patient care, family support, effective communication, and interdisciplinary teamwork. In
•
Phase 2: 412 International associations for
this perception it was very clear that the focus was
hospice and palliative care in 88 countries
very narrow.
expressed their level of agreement with the suggested components
The 4 subjective frames on palliative wound care by wound care nurses are as follows:
•
Phase 3: The expert panel developed the definition
•
“Focusing on care within the boundary of current patient demands”
Figure 1 shows a mapping of geographic areas included in their consensus. It does not solely show
•
the number of countries, but also shows how it was
“Comparing continuously the priorities on wound healing and disease care”
spread over high upper middle, low upper middle-, or low-income countries.
•
“Preparing and preventing from worsening via tracking care in advance”
Figure 1: Geographic areas included in the consensus.
•
“Moving forward with a clear direction by confronting the declining condition”
1 2 3 4 Low income Lower-middle income Upper-middle income High income
The first frame may be deemed as the most reflective on the matter, as it focuses on care within the boundary of patient needs. It is a very patient focused concept, not a one-size-fits-all approach.
Wound Masterclass - Vol 2 - December 2023
71
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management
“It is a very patient focused concept, not a one-size-fits-all approach.”
Through the task force the aim is to define the concept
definitions and scopes on the matter to become very
of palliative wound care through a scoping review
limited to these Western countries.
of the literature, to conceptualize palliative wound care in terms of its definition, elements, and any
It
differences with general wound care management
commentaries (n=70), while the remaining were
(preliminary findings). The aim was to do this via a
book chapters (n=11), case reports or case series
methodologically sound approach that would be
(n=9), consensus statements (n=6), prospective
accepted by all; therefore, the meta-aggregative
and observational studies including cohorts (n=6),
approach was ideal as it guided researchers to pool,
conference
compare and summarize data to understand the
descriptive quantitative studies including surveys
definition and concepts of palliative wound care.
(n=5), qualitative studies (n=4), retrospective studies
There were 4 stages in this:
(n=3), theses (n=3), and other (n=11).
1.
Development of the review question and search
It also included a range of aetiologies; this is vital
strategy
because palliative wound care is often viewed via
Literature searches, screening and data
the lens of cancer care, so it would be expected that
extraction
much of it was focused around malignant fungating
Pooling of all the extracted data and mapping of
wounds. However, in this research, the opposite
main and sub-categories
was found instead, in that 46% had a broad range of
Further data synthesis
wound aetiologies, and 22% had malignant fungating
2. 3. 4.
included
systematic
abstracts
reviews,
including
editorials
posters
or
(n=5),
wounds; therefore it was really strong. The inclusion criteria consisted of reports that refer to the definition, concept, components, elements,
The most repeatedly used phrases were unsurprisingly
principles, or goals of palliative wound care as a
about symptom management, and quality of life. Also,
primary or secondary source; pieces of literature
psychological or psychosocial issues, and symptom
(including grey literature) that follow any methodology
control.
and design; published any time (no year limits), and published in English. The searches were performed in the following electronic databases: Ebscohost CINAHL Complete, Ovid Medline, Cochrane Library, and Scopus. Google Scholar was also searched to identify additional reports. •
2694 records were identified for title and abstract screening
•
196 full texts reports were read in detail
•
133 were included in the data synthesis
Most of the reports were from or led by authors from the United States (n=56), United Kingdom (n=24), and Canada (n=10), followed by European countries (n=17). Unlike palliative care research being taken from all countries and all income settings, palliative wound care is a lot more restricted and niche, causing for
72
Wound Masterclass - Vol 2 - December 2023
Figure 2: Wound aetiology.
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management
“This new concept is in attempt to capture all the various core elements of what palliative wound care is.”
Emerging from this were 3 key themes, the first being
factors that patients encounter, and that requires a
palliative wounds, looking at the types of wounds,
pain specialist. There is much more engagement and
the healing potential, and the patient population it
interaction on an ongoing basis. Focusing on patient
affected; secondly, the impact on individuals and
and family goals requires the constant assessment
family, which regarded things such as social isolation
of what the needs are of the patient, and what their
and distress, the quality of life, and their function and
goals are. For example, this may include control of
wellbeing; finally, the care approach - what were the
odour, or control of bleeding, etc.
goals, principles, and existing needs of the patients. There are some similarities between the two, but the This new concept is in attempt to capture all the
major difference is that the focus is not on healing, but
various core elements of what palliative wound care
rather on the symptom management, and alongside
is; that is, person and family centred, holistic and
this there is a large focus on psychological wellbeing.
interdisciplinary care of wounds that may heal, or not, or may be too onerous to treat; including but not limited to symptom control and management, for individuals who are often vulnerable and have impaired quality of life. This comes from over 100
Table 1: TIME (tissue, infection/ inflammation, moisture, edge), wound bed preparation, a range of potential nursing interventions, methods, and generic products for palliative wound care.
documents reviewed. Comparing Palliative Care with Palliative Wound Care
TIME
Wound bed preparation
Methods and generic products for palliative wound care
Tissue Necrotic
Debride the necrotic tissue
Autolytic debridement: hydrogel, hydrocolloid, honey, alginate, hydrofibre dressings Biological debridement: larval therapy
It compares very well because it includes being person centred, holistic, multi-disciplinary, not limited
Mechanical debridement: ultrasound
to end-of-life care, not limited to cancer care, and with a large focus on quality of life. This looks to the quality of life for patients, but also of families and carers. Looking at the concept of palliative wound care brings the question of what the difference is
A chapter in the Oxford Textbook of Palliative
between palliative and curative wound care. Emmons
Medicine has been updated, using the time-based
and Lachman have produced a lot of work regarding
approach in order to look and see how we would
this matter, however the principles of what they have
address and approach palliative wound care, in
stayed through, even to today. Essentially, in general
comparison to general wound care.5 Using the time
wound care, the goal is healing. It could be to control
anacronym (tissue, infection/inflammation, moisture,
and eliminate causative factors, for example pressure
edge, or epithelial edge advancement), looking at
in the area of pressure ulcers. Also, to provide
necrotic tissue for example, it may be to debride
systemic support to reduce existing and potential
them, and then seeing what agents may be suitable
cofactors, and to maintain a local environment that
for it. However, this depends on a comprehensive
promotes healing. When the goal is palliative, the
assessment of the patient, the wound, and of the
focus is symptom management, psychological well-
goals of care.
4
being, multidisciplinary team approach, and a focus on patient and family goals. One could argue that a
The palliative wound care framework is driven by
multidisciplinary approach is required in all cases, and
patient and family goals integrated with:
it is. However, in the area of palliative wound care, it is more evident, and it is more necessary on a dayto-day basis. For example, pain is one of the major
•
Management of palliation of the underlying cause
Wound Masterclass - Vol 2 - December 2023
73
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management
“Odour control is one of the key components of palliative wound care.”
Management of wound related symptoms: pain,
The goals are to provide comfort and maintain the
odour, exudate, and bleeding
best possible quality of life. These include:
Management of the wound and peri-wound skin
•
Pain management
To summarise, palliative wound care is not time
•
Symptom control
•
Wound odour management
•
Preventing wound complications
•
Education and support for caregivers
•
Honouring the patient’s preferences and goals
•
•
limited and is focused on patient and family goals. The concept of palliative wound care can guide policy, resources allocation and services provision. Major wound symptoms include pain, odour, exudate and bleeding. Palliative wound care differs from general wound care in many areas but particularly for the outcome of healing. There is also a critical need and importance for research to develop this area of practice. In palliative care there are multiple different wounds that can affect patients at the end of life.
Odour control is one of the key components of
These wounds are those that are not amendable
palliative wound care. It has been found that medical
to healing at this point in time, and the focus is on
practitioners working in wound care have become
what the patients desires are. These can be any
desensitized to the odour. However, a key aspect
kind of wounds from venous wounds to chronic
concerns how children do not want to be around this
osteomyelitis, any kind of wound where the goal is
odour, and as the patient would like to be around
no longer aggressively healing, but to maintain the
grandchildren and family members, it is vital to
environment and prevent the wound from becoming
maintain an environment where they can do so.
an issue for the patient. Palliative wound care is slightly neglected, and is not very well known in the
Wound Challenges
field of chronic wounds. The focus is on maintaining the quality of life for the patients, therefore more
Palliative care patients often have complex wounds
focus is placed on symptom management to have a
including pressure injuries, wounds related to chronic
better quality of life, and here dressings can be used
diseases, vascular impairments or malignancies and
to lower wound odour, for example.
they pose challenges due to their size, depth, varied aetiologies, and associated symptoms like pain Global expert
Dr John David Thomas CEO/ Medical Director for Solutions Medical Group
and drainage. healthcare providers must have the expertise needed to evaluate, treat, and manage these complex wounds effectively. Symptom Control
Humble TX, United States
The symptom control is important to handle the
Challenges Faces in Palliative Wound Care
excessive exudate drainage and malodour infection. The drainage can be overwhelming at times, and
My aims and objectives are to identify the challenges
therefore a highly absorbent dressing is required
in daily practice, the challenges in the management
to control the odour and keep the wound from
of palliative care wounds, and identify examples
macerating and creating further complications. It
of skin damage and palliative wounds, including
is easier for a saturated wound to become infected
pathophysiology.
and have significant malodour. Zetuvit serves as an excellent choice for a dressing and may be regarded
74
Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management
“Stigma and misconceptions around palliative wound care include the mistake of associating palliative care with hospice care, or end of life care, and it is not necessarily the same.”
as the best dressing in wound care today.
There are different dressings showing the absorption of bacteria, and Figure 4, Table 2 shows the different kinds of dressings available on the market that are
Figure 3: Zetuvit Plus Silicone/Border Structure and Mechanism of Action.
lowering the bacteria loads, whether it is in the dressing or that they release their components to eradicate the bacteria and to lower the mmps. Odour management and pain management can be classed as the two most important components in palliative care. Figure 4: Standard of Care vs superabsorbent dressings.
Wound healing
Increased QualityAdjusted Life Weeks
Quality of life
2.9% increase in healing rate
Cost
£222 saved per person over six months
Standard of Care
Superabsorbent dressings
Standard of Care vs Superabsorbent Dressings Table 2: Examples of Non-Medicated Wound Dressings exhibiting absorption of bacteria, MMPs and endotoxins into the matrix of the wound dressing.
Considering standard of care vs superabsorbent dressings, a 2.9% increase in healing rate is shown with the superabsorbers due to the fact they keep the
Foams
Krejner and Grzela, 2015
CMC dressings
Newman et al., 2006; Walker et al., 2003
Superabsorbent polymer (SAP)-containing dressings
Eming et al., 2008; Wiegand et al., 2011; Wiegand and Hipler, 2013; Wiegand and White, 2013
Dialkylcarbamoylchloride (DACC)-coated dressings
Bowler and Davies, 1999; Ljungh et al., 2006; Ronner et al., 2014; Wadstrom et al., 1985; Butcher, 2011; Brackman et al., 2013; Geroult et al., 2014
or simply become less of a burden to the patient, this
HRWDs
Rippon et al., 2018; Bruggisser, 2005; Ousey et al., 2016
the quality of life, whilst saving costs.21-35
Table 3: Examples of NMWDs with evidence of sequestration of bacteria.
correct environment for a wound. In palliative care it is not necessarily about healing the wound, but if a wound heals during the care this is a good outcome. If the chances of the wound healing can be assisted, is a goal that would be highly favourable; it increases
Stigma and misconceptions around palliative wound care include the mistake of associating palliative
DACC-coated dressings
Bowler and Davies, 1999; Ljungh et al., 2006; Ronner et al., 2014; Wadstrom et al., 1985; Butcher, 2011; Brackman et al., 2013; Geroult et al., 2014
care with hospice care, or end of life care, and it is
HRWDs
Rippon et al., 2018; Bruggisser, 2005; Ousey et al, 2016
mistakenly viewed as surrendering or losing hope and
Hydroconductive
Edwards-Jones et al., 2014
CMC dressings
Newman et al., 2006; Tachi et al, 2004; Walker et al., 2003; Bowler and Davies, 1999; Waring and Parsons, 2001
SAP-containing dressings
Butcher, 2015
Others
Desroche et al., 2016; Westgate and Cutting, 2012
not necessarily the same. Palliative care is likely to be delaying access to appropriate services. End of life care is much different to palliative care. It is possible for a patient to be in good health with good amount of years ahead of them, and still require palliative
Wound Masterclass - Vol 2 - December 2023
75
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management care. For healthy elderly patients with open chronic
as possible.
wounds, treating the wound to heal it would take up valuable time in which the patient could be spending
Examples of Skin Damage and Palliative Wounds,
time with their family, rather than being in the clinic
Including Pathophysiology
daily. A palliative care option is much better for this case as it would enable the patient to maintain a
Pressure injuries
proper wound environment, whilst not disturbing the ability for the patient to enjoy the rest of their life.
•
Pressure ulcers develop due to prolonged pressure on the skin, particularly over bony
Another challenge involved with palliative care
prominences
regards communication. Effective communication with the family members of the patient, as well as
•
Pressure disrupts the delivery of oxygen,
all of the nursing staff is imperative to ensure that
circulation, and nutrients, resulting in tissue
the goal and focus is clear. There may be cultural
ischemia and subsequent breakdown
and language barriers with family members, as well as conflict, as there may not be a shared goal with
A lot of palliative patients tend to be more sedentary,
how to proceed with the patient’s care. It is crucial to
causing for skin to breakdown and pressure ulcers to
ensure they understand and are informed during the
be formed. It is important to maintain an environment
process.
where the patient is moving and kept clean and dry. This is a great contrast to end of life care where the
Care coordination is also vital. The need for
patient is mainly kept comfortable in bed.
coordination arises from the fact the patient is in various
healthcare
settings,
including
hospitals
Osteomyelitis
and home care. Ensuring smooth transitions and consistent delivery of care can be a challenge,
•
Very conservatively treating open wounds
especially when patients have complex medical
combined with stopping antibiotic therapy can
requirements or frequent hospital readmissions.
set the stage for the development of infection,
Communication also proves to be very important in
osteomyelitis, and sepsis
this matter. The bacterium is highly resistant, and the effects There is also the need for psychosocial support
of antibiotics may be detrimental to the patient.
and ensuring for sensitivity and compassion. This
Maintaining an environment that is conducive to
will help to establish a supportive environment
the patient’s life goals and reducing the infection,
where patients and families feel comfortable. The
drainage and odour will greatly assist this problem.
challenge is essentially preventing complications. The primary focus is on comfort and symptom
Malignant wounds
management. Exudate wounds can lead to infection and tissue breakdown with maceration. Preventing
•
Malignant wounds arise when cancer infiltrates
complications looks heavily to control exudate and
the skin or occurs due to tumour growth. This
drainage. By successfully controlling this, the odours,
can happen through direct invasion, metastasis,
maceration and tissue breakdown become reduced,
or tumour necrosis. Malignant wounds are
possibly even helping the body to continue to heal.
often irregularly shaped, friable, malodorous, have exudate, bleeding and/or necrotic tissue.
Pain management is another vital aspect for the
They can be painful and prone to infection
patient, and one of the most prevalent issues with this is changing the dressing. Changing the dressing
Wound vacs can be used for malignant wounds. They
is uncomfortable for them, therefore changing the
are usually contraindicated for cancer, but in palliative
durations and frequency of this can help reduce the
care, it can be used to control exudate flow. It is not
amount of discomfort the patient endures. Super
about healing the wound, but rather controlling
absorbent dressings with silicone base are excellent
odour and drainage.
for fulfilling this goal as the silicone base will not stick to the wound and the super absorber would wick
Venous Leg Ulcers (VLUs)
away the moisture from the skin, providing a longer duration between the dressing changes. Lots of the
76
•
Chronic venous insufficiency, which leads
patients have opioid tolerance, hence the importance
to venous hypertension, compromised
to reduce the stimulation to the wound as much
microcirculation, and tissue injury
Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management •
Typically occur around the ankles and lower legs
•
Often present as shallow, irregularly shaped wounds with a moist wound bed, surrounding edema, heavy exudate, and hemosiderin staining in periwound
require lots of compression dressings, and patients are usually at this point tired of chronic wound care. These kind of wounds have a high amount of exudate; therefore, it is important to develop a plan to treat the wounds and keep the exudate down to reduce maceration or destruction of tissue.
unaware that they are harming the wound and making it worse. Considering the patient’s situation diet, it is important to communicate properly with the patient and family, ensuring they can still enjoy life but maintain a proper environment that will not harm the wound further. Surgical wounds Incision and tissue trauma
Surgical wounds regard another issue where the
Arterial ulcers develop due to inadequate arterial blood supply to the lower extremities caused by peripheral arterial disease, atherosclerosis, and/or arterial restriction or occlusion
treatment offered in palliative care may not be accepted by surgeons as they are not as open to it. Due to the lack of understanding regarding palliative care, some of the treatments and plans are not accepted well as the surgeon would often have their strong opinion of the wound and how they would like
Reduced oxygen and nutrient delivery result in tissue ischemia and ulceration
•
peripheral neuropathy makes it so the patient is
•
Arterial ulcers
•
They are a huge problem in wound care. The
of also living with diabetes and being put on a strict
Venous leg ulcers can be difficult to treat; they
•
prompt treatment is delayed.
to handle it. This is where communication with the patient and surgeon proves to be vital.
Typically located on the feet, toes, or lateral
Global expert
ankle •
Prof Sebastian Probst Immediate Past President EWMA Full Professor of Tissue Viability and Wound Care at the School of Health Sciences
Characterized by deep, “punched-out” wounds with minimal exudate, pale granulation
Geneva, Switzerland
tissue, and surrounding ischemic changes like coolness, shiny skin and hair loss Arterial wounds can be very painful, and, in this situation, it is important to notice the aetiology of the wound, and what the goals are. In palliative care, invasive treatments can still be done such as angiogram with intervention, in order to decrease pain rather than trying to heal the wound.
non-healable wounds or palliative wounds such as malignant fungating wounds.6
perception of wellbeing, happiness and satisfaction
Diabetic foot ulcers (DFUs) occur due to peripheral compromised
Quality of life is often more relevant for people with
Generally, quality of life is defined as a general
Diabetic Foot Ulcers (DFUs)
neuropathy,
Quality Of Life for Patients with Palliative Wounds
circulation,
trauma,
impaired wound healing associated with diabetes and hyperglycaemia; neuropathy leads to decreased sensation, making patients prone to repetitive trauma and pressure injuries. Diabetic foot ulcers primarily affect the feet, particularly areas subject to increased pressure. They are often deep, with a necrotic base, undermined edges, and signs of infection. With peripheral neuropathy, these wounds often go undetected and
by an individual. It is a subjective but dynamic concept influenced by functional capacity, past experiences, personality,
self-esteem
and
interprofessional
relationships. Quality of life refers to the sense of wellbeing that is specifically associated with health and illness. A quality of life goal may be to reduce pain and prevent suffering. Striving for quality outcomes in patients with non-healing or palliative wounds is particularly significant when wound healing is not a realistic outcome. The complexity of quality of life is often understood in terms of overlapping dimensions. The different components may carry more importance at a given time based on the context
Wound Masterclass - Vol 2 - December 2023
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MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management of health and illness.
wounds due to the exudate being manageable, however it became worse and the furthest the patient
Functional Limitations That Wounds May Have On
could walk to was their garden. The patient would
Patients
then stay in bed.
•
Palliative wounds, especially those in
This kind of incident can trigger many
challenging locations or with significant size
psychological issues such as:
or drainage, can limit a patient’s mobility and independence
•
Effects of wounds on patients’ sense of self
Resulting in decreased ability to perform daily
•
Impact on relationships
and recreational activities
•
Lack of sleep
Strategies such as assistive devices, wound
•
Frustration
implemented to optimize functional capabilities
•
Exudate
Social support is very important. Engaging patients
•
Malodour
•
Depression
•
Altered body image
enhance the time they have with their families.
•
Social isolation9
Cancer Diagnosis and Palliative Wounds
Negative Impact on Quality of Life
Living with a cancer diagnosis is traumatic enough
Wound pain management with the frequency of
without the added physical and psychological burden
dressing changes are very important. The dressings
of a malignant wound. In this study, 9 women were
should be very comfortable, especially with the
living with malignant wounds.7 They displayed
exudate and bleeding. Patients are informed what to
the difficult of dealing with unpredictable wounds
do when it starts bleeding, as well as what to do with
because it can produce a lot of odour, exudate, or
malodour.
•
activities, self-care, and participation in social
•
positioning, and rehabilitation services may be
in support groups, connecting them with community resources, involving family and friends in their care, and promoting open communication can enhance social support and improve overall well-being. This will promote a better quality of life for them and
there are problems with bleeding and pain. There may also be the embarrassment of having the wound.
Patients living with such wounds have also expressed their struggles verbally. Their comments range from
Another study illustrates the caregiver’s experience.8
their diet and nutrition compromises to accommodate
It had been concluded that when providing care to a
pain management with their wounds, to the excessive
wound they experience shock, disgust, and nausea.
labour of handling exudate.11 Comments regarding
They had also described feelings of isolation and lack
pain would involve “My sleep and rest always break off
of knowledge for how to care for a wound, especially
because of slight to mild shooting and stabbing pain”,
doing so for their loved ones. These studies show that
“I only eat soft cold noodles and bread, because those
the key to improve quality of life for these patients
can decrease my mouth wound pain”. With exudate
is having access to a wound care team or specialists
they commented that “It [exudate] was festering like
who can educate patients and caregivers on how to
a running nose”, “ had to redo my dressing nearly
care for wounds with the appropriate dressings, how
every four hours because it was leaking”. In regard
to control exudate and wound odours.
to bleeding, they would “always suffer from bleeding after a change of dressing or slight exercise”, and “I
78
As it has been shown with malignant fungating
sought for medical assistance for the wound when I
wounds, they have a profound impact on the patient’s
couldn’t stop the bleeding”. This is problematic with
quality of life. This study shows what kind of impact
for their weight and health. As for the odour, patients
it can have on the relationships of patients and
have commented saying “you might compare it with
their caregivers. For example, a patient’s caregiver
the smell of a piece of rotting meat”, to it being “very
(partner) reported that their ability to move around
stressful when someone told me I stank”. In palliative
was decreasing. Initially, they could travel with their
wound care, it is important to promote comfort,
Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management alleviate pain and prevent infections to optimize the patient’s quality of life, and effectively maintain the wound in a stable, manageable state. When speaking of wound symptom management, we must look at common therapeutic approaches in palliative wound care. Therapeutics in palliative wound care focus on:
practice. Tranexamic acid can be used in home care, with instructions provided to the caregivers on how to use them if the wound starts to bleed. Additionally, other vasoconstrictions may be used, such as adrenaline. The gauze can be soaked and applied with pressure depending on the pain, not more than 10 minutes. Doing this task under 10 minutes will prevent a necrosis.
•
Promoting comfort
•
Symptom management
•
Alleviating pain
•
Preventing infection
•
Maintaining the wound in a stable and
Darker bedsheets are recommended for the patient to use, to enable the bleeding of the wound does not do further damage on their psychological state, as well as the caregivers. This helps to mitigate panic and the feelings of incompetency as revealed earlier. For exudate management there are three important
manageable state •
Calcium alginates are used very often in clinical
indicators: the dressing fit, the volume of exudate leakage, and the number of dressing changes.15 Malignant fungating wounds can produce up to one
Optimizing the patient’s quality of life
A Canadian publication from Kevin Wu shows what medical practitioners can do in a clinical practice for the management of pain in palliative wound care.12 Morphine can be used, or topical lidocaine. Dressings with ibuprofen may also be used, and potentially methadone. Capsaicin (0.025 – 0.075%) can be an ointment, and also the dressings including silicon are recommended.
litre of exudate, hence the importance for this. Superabsorbent dressings should be used to manage heavily or moderately exudative ulcers. Those with a silicone layer should be used. Polyurethane foam dressings have an exudate absorption and an autolysis debridement capacity, meaning it may also be used. It has also been suggested that silverimpregnated foam dressings can be used to lower and protect wounds from bacterial colonization.16 If there is an alginate with silver, it can be covered
In regard to what can be done systemically, the understanding is that up to 70% of chronic wounds have nociceptive pain and neuropathic pain. NSAIDs, opioids and anticonvulsants can be used to address this. A critical literature review reveals that an effective way of using topical morphine is by mixing 10mg of it with 8g of hydrogel. A pharmacist can mix this, allowing it to be applied without any problem. To manage the bleeding in palliative cases, the classical 10 times daily 3 gy fractionation schedule during weekdays is the most appropriate dose.13 Other
easily with another. However, with a superabsorbent dressing you would not require another one, due to its absorption capacities. Negative pressure wound therapy (NPWT) has been supported as a potential method for exudate management in a palliative setting.17,18 Despite it being a contraindication for a malignancy, if the goal is to alleviate pain and enhance quality of life, and considering the patient’s life, it then could be a possibility. The use of NPWT for malignant wounds
possibilities include topical haemostatic agents:14 Figure 6: Tools for the Subjective Assessment of Wound Odour. Figure 5: Category
Example
Comments
Natural haemostats
Calcium Alginates Collagen Oxidized cellulose
Controls minor bleeds Available as a dressing material Bioabsorbable
Coagulants
Gelatin sponge Thrombin
Risk of embolization
Sclerosing agents
Gelatin sponge Silver nitrate
May cause stinging and burning upon application Leaves a coagulum that can act as a pro-inflammatory stimulus
Fibrinolytic antagonists
Tranexamic acid
Oral agent Gastrointestinal adverse effects (nausea/vomiting)
Astringents
Alum solution Sucralfate
May leave a residue on wound
Vasoconstriction
Adrenaline
Gauze soaked in adrenaline 1:1000 applied with pressure for 10 minutes
Odour Assessment
Scale System
Visual Analogue Scale
Scale from 1 to 10, where 1 is no odour and 10 is extremely strong odour
Verbal Rating Scale
Scale from 1 to 4, where 1 is no odour and 4 is strong odour
Verbal Rating Scale
Strong (intolerable), moderate (noticeable), minimal (barely noticeable), absent (no odour)
Baker and Haig Method
Scale from 1 to 4, where 1 is strong odour and 4 is no odour
Not indicated
Scale from 0 to 4, where 4 is strong odour and 0 is no odour
Overall Evaluation Scale
Scaled from 1 to 10, where 10 is excellent odour control
Teller Odour Indicator
Scaled from 0 to 5, where 0 is no odour, 4-0 is when odour is sensed during dressing changes and at certain distances from the patient
Wound Masterclass - Vol 2 - December 2023
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MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management may have utility as a palliative therapeutic intervention
To summarise, the evidence available and from
to reduce complications associated with the wounds
clinical practices show that palliative wounds can
and to increase patient comfort.
affect the quality of life. A holistic approach to improve the quality of life is needed. In managing
With odour management, it is important to reflect
exudate, superabsorbent dressings would work
how odour is documented. In wound documentations
best. Metronidazole and silver may be used in
regarding odour, there is often a yes or no. To be more
controlling wound odour In a palliative setting, NPWT
accurate, a visual analogue scale would be highly
may be used for malignant wounds. New research
useful. This assessment tool would be beneficial.
is important as it is heavily lacking in the field of
19
palliative wound care. There are different rating scales to assist document better. This enables a more objective data that is easier to work with. Treatment options to manage wound odour are limited. There is a lack of research, and in the field of palliative wound care the small sample sizes are very low. Are also an absence of defined standardized outcomes and consistent measurement. The widely used topical application, for
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example metronidazole may be used. Metronidazole and silver may have a role in controlling wound odour. Robust and well-designed interventions standardized odour outcomes are needed.20
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17. Pflibsen, L. R., Lettieri, S. C., Kruger, E. A., Rebecca, A. M., & Teven, C. M. (2020). Negative Pressure Wound Therapy in Malignancy: Always an Absolute Contraindication?. Plastic and reconstructive surgery. Global open, 8(8), e3007. https://doi.org/10.1097/GOX.0000000000003007 18. Cai, S. S., Gowda, A. U., Alexander, R. H., Silverman, R. P., Goldberg, N. H., & Rasko, Y. M.(2017). Use of negative pressure wound therapy on malignant wounds - a case report and review of literature. International wound journal, 14(4), 661-665. https:// doi.org/10.1111/iwj.12665 19. Akhmetova A, Saliev T, Allan IU, Illsley MJ, Nurgozhin T, Mikhalovsky S. A Comprehensive Review of Topical Odor-Controlling Treatment Options for Chronic Wounds. J Wound Ostomy Continence Nurs. 2016; 43(6):598-609. do: 10.1097/ WON.0000000000000273 20. Gethin, G., Vellinga, A., McIntosh, C., Sezgin, D., Probst, S., Murphy, L., Carr, P., Ivory, J., Cunningham, S., Oommen, A. M., Joshi, L., & French, C. (2023). Systematic review of topical interventions for the management of odour in patients with chronic or malignant fungating wounds. Journal of tissue viability, 32(1), 151-157. https:// doi.org/10.1016/j.jtv.2022.10.007 21. Cost effectiveness analysis: health economic studies. How to use a cost effectiveness analysis to evaluate your digital health product. Office for Health Improvement and Disparities 13 October 2020. https://www.gov.uk/guidance/ costeffectiveness- analysis-health-economic-studies 22. Harding K, Carville k, Chadwick P et al WUWHS Consensus Document: Wound Exudate, effective assessment and management. 2019 23. Velickovic Vet al. Cost-effectiveness analysis of superabsorbent wound dressings in patients with moderate-to-highly exuding leg ulcers in Germany. Int Wound Journal. 2022; 19(2)-447-59. Doi:10.1111/iw.13645 24. https://www.woundsource.com/blog/what-are-superabsorbent-dressings 25. Cochrane Database Syst Rev. 2018: 2018(6): CD012583. Published online 2018 Jun 15. doi: 10.1002/1 4651858. CD012583 pub2 26. Made Easy. Zetuvit Plus Silicone Border. Wounds UK. December 2019. https:// www.woundsinternational.com/resources/details/made-easy-zetuvit-plussiliconeborder 27. Michael W Rich, MD, Robert F. Nease, PhD. Cost-effectiveness Analysis in Clinical Practice. Arch Intern Med. 1999,159(15):1690-1700. doi:10.1001archinte.159.15.1690,August 1999. 28. Velickovic Vet al. Cost-effectiveness of superabsorbent wound dressing versus standard of care in patients with moderate-to- highly exuding leg ulcers. Journal of Wound Care Vol 29, No 4, April 2020. 29. Velickovic Vet al. Cost-effectiveness analysis of superabsorbent wound dressings in patients with moderate-to highly exuding leg ulcers in Germany. Int Wound J. 2021; 1-13. https://doi.org/10.1111/iw13645 30. Velickovic Vet al. Superabsorbent wound dressings versus foams dressings for the management of moderate-to-highly exuding venous leg ulcers in French settings: An early stage model-based economic evaluation. Journal of Tissue Viability, https:// doi org/10.1016/jjtv.2022.04.005 31. Velickovic V, Jankovic D. Challenges around quantifying uncertainty in a holistic approach to hard-to-heal wound management: Health economic perspective. Int Wound I. 2022;1-7, dot: 10.11 11/w.13924 32. Velickovic Vet al. Individualised risk prediction for improved chronic wound management. Advances in Wound Care© Mary Ann Liebert, inc. DOI: 10.1089/ wound 2022 0017 33. Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK’s National Health Service in 2017/2018 update from 2012/2013. BMJ Open 2020,10(12).e045253. 34. Augustin M, Brocatti LK, Rustenbach SJ, Schafer I, Herberger K. Cost-of-illness of leg uicers in the community, Int Wound J 2014,1 1(3) 283-92. 35. National Institute for Health and Clinical Excellence (NICE. Process and methods guides. Guide to the technology appraisal and highly specialised technologies appeal process. London, 2014
woundmasterclass.com/Podcast
How Can A Biodegradable Matrix Offer Limb-Saving Options for Chronic Ischaemia? Editorial Summary BTM is a dermal matrix that are commonly used in extensive and hard to heal wounds. This dressing adjunct can cover important structures to maintain structural function such as vessels, joint capsules, bone and tendons.
Introduction
C
onsent was gained from the patient to share photo’s in this case study. NovoSorb® Biodegradable Temporising Matrix (BTM) has been studied reasonably extensively in patients with burns, necrotising fasciitis and, more recently, in diabetic foot disease. However, there is a paucity of literature in the setting of tissue loss secondary to chronic limb threatening ischaemia (CLTI). BTM is a dermal matrix that are commonly used in extensive and hard to heal wounds. This dressing adjunct can cover important structures to maintain structural function such as vessels, joint capsules, bone and tendons. This is important in vascular patients to enable them to continue to be mobile avoiding major limb amputation which could then lead to a longer hospital admission and for some, loss of independent living. The matrix is initially placed over the defect to create a neodermis.
Ms Victoria Bristow Vascular Specialist Nurse, Cambridge University Hospitals Cambridge, United Kingdom
82
Our first case using BTM was a 62-year-old male who presented with CLTI and extensive tissue loss involving the dorsum of the foot, multiple toes and the calf. Revascularisation by means of iliacangioplasty and femoral to femoral cross of graft was carried out. Debridement of the foot wasrequired including amputation of 2nd-5th toes. BTM was applied to the dorsum of the foot and the calf. Delamination was carried out at 8 weeks. His wounds were fully healed at 24 weeks.
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On presentation to the emergency department, he had extensive necrosis and lower limb ischaemia with only a femoral pulse palpable on the right leg. When speaking to the patient and his daughter he had presented 3 times at a local district hospital and was misdiagnosed. He was admitted to the vascular ward for further investigations and revascularisation by the means of a left to right femoral crossover graft using Polytetrafluoroethylene (PTFE) graft. Figure 1:
How Can A Biodegradable Matrix Offer Limb-Saving Options for Chronic Ischaemia?
“The matrix was applied in theatre under general anaesthesia in full sterile conditions. With the BTM the wound needs to be able to bleed through the matrix to encourage angiogenesis and create a neodermis.”
Several days later whilst admitted on the ward his toes began to declare themselves and demarcate. Discussions then began with the team whether his leg was salvageable due to the large area of tissue loss. It was decided that the patient would be discharged home to continue to allow the leg to demarcate. A consultant colleague and I had recently attended a talk showcasing BTM in burns patients from Australia. These case studies had large areas of tissue loss and it was felt this product would be suitable to the vascular patient group. The patient was counselled as to this being the first time this product was being used by our centre but was aware due to the large amount of tissue coverage needed the only other option would have been a below knee amputation and the patient was keen to try and salvage his limb.
The matrix was applied in theatre under general anaesthesia in full sterile conditions. With the BTM the wound needs to be able to bleed through the matrix to encourage angiogenesis and create a neodermis. It is secured using staples and negative pressure wound therapy (NPWT) is placed on top this was used for protection and as well as exudate control. Dressing changes were done weekly for 7 weeks, wound photos were taken and the NPWT was replaced on both the forefoot and posterior calf. Contraction of the wound was visible. After 7 weeks the graft was delaminated, the staples were removed and the sealing membrane was peeled back. Once removed some slough was present but granulation tissue was present with islands of epithelisation occurring. Figure 3: 3a
3b
He was reviewed regularly in the outpatient clinic. Sharp debridement was carried out but there was concern that this eschar was covering and protecting important structures including tendons, bone and blood vessels. Figure 2: 2a
2b
2c
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How Can A Biodegradable Matrix Offer Limb-Saving Options for Chronic Ischaemia?
“BTM provides a useful adjunct to aid wound healing in revascularised CLTI patients with extensive tissue loss, especially when exposed tendons and bones are present.”
Figure 6:
Figure 4: 4b
4a
6a
6b
Figure 5: 5a
5b
To conclude, we have found that BTM provides a useful adjunct to aid wound healing in revascularised CLTI patients with extensive tissue loss, especially when exposed tendons and bones are present. Simple dressings were then applied from now on with silver as the primary dressing as per the instruction for use from PolyNovo®. This was carried out by district nurses until week 24 at which the wound had fully healed.
References 1. Novosorb® Biodegradable Temporising Matrix (BTM) and its Applications. Lim P, et al. Surg Technol Int. 2023. PMID: 37053370 2. Clinical outcomes and resource utilisation in patients with major burns treated with NovoSorb® BTM. Betar N, et al. Burns. 2023. PMID: 37344307 Free article. 3. Long-term scarring outcomes and safety of patients treated with NovoSorbⓇ Biodegradable Temporizing Matrix (BTM): An observational cohort study. Lo CH, et al. JPRAS Open. 2023. PMID: 37360978 Free PMC article. 4. Treatment of Complex Wounds with NovoSorb® Biodegradable Temporising Matrix (BTM)-A Retrospective Analysis of Clinical Outcomes. Schlottmann F, et al. J Pers Med. 2022. PMID: 36556223 Free PMC article. 6. Artificial dermal templates: A comparative study of NovoSorb™ Biodegradable Temporising Matrix (BTM) and Integra(®) Dermal Reg 7. Experience with NovoSorb® Biodegradable Temporising Matrix in reconstruction of complex wounds. Li H, et al. ANZ J Surg. 2021. PMID: 34085755 Free PMC article. 8. Treatment of Necrotizing Fasciitis with NovoSorb® Biodegradable Temporizing Matrix™ and RECELL® Autologous Skin Cell Suspension: A Case Series. Austin CL, et al. J Burn Care Res. 2023. PMID: 38085950 9. Upper Extremity Wounds Treated with Biodegradable Temporizing Matrix versus CollagenChondroitin Silicone Bilayer. Wu SS, et al. J Hand Microsurg. 2022. PMID: 38152680 Free PMC article. 10 NovoSorb Biodegradable Temporizing Matrix for Reconstruction of Multiplanar Degloving Injury of the Upper Limb. Knightly N, et al. Plast Reconstr Surg Glob Open. 2023. PMID: 37020984 Free PMC article.
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polynovo.com
Supported by
What Is the Role of Platelet-Derived Biologics? Editorial Summary This article explores the surgical strategy of platelet-derived orthobiologics, providing an overview of the benefits of their use and a consideration of the future of these products.
Introduction
O Prof Anand Pillai Consultant Orthopaedic Foot & Ankle and Adult Reconstruction Surgeon Manchester, United Kingdom
rthobiologics therapies have gained considerable interest in recent years. They are increasingly becoming popular for treatment of a variety of musculoskeletal pathologies. The term ‘biologic’ refers to a naturally occurring substance with the ability to heal, and ‘ortho’ refers to its application in musculoskeletal tissue. They are different from ‘biologic’ drugs commonly used now for treatment of rheumatological conditions. A wide array of orthobiologics are available but the broad categories of preparations include, but are not limited to: autologous blood products, cell-based therapies, and growth factors. In this article, various autologous blood products and their roles are discussed.1 Autologous blood products refers to any preparation derived from a patient’s whole blood. These include a range of products that can be further categorised into platelet-rich plasma (PRP), platelet poor-plasma (PPP) and autologous anti-inflammatory preparations (AAIs).2 Figure 1: Steps in preparation of PRP and PPP.
Dr Vish Kumar Consultant Orthopaedic Foot and Ankle Surgeon at Wye Valley NHS Trust & Spire Banks Hospital Worcester, United Kingdom
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As ‘natural’ treatments, these products are an attractive option for both patients and clinicians as they eliminate concerns about immunogenic reactions and disease transmission. Platelet-rich plasma is a volume of plasma fraction of autologous blood having platelet concentrations above baseline where platelet count is usually 5 times higher than that of blood. PRP was first used to aid wound healing in 1987 after cardiac bypass surgery. It was first used in orthopaedics in 2003 for treatment of recalcitrant tennis elbow. PRP can be prepared in the laboratory, in the operating theatre or the clinic, from venous blood collected immediately before treatment. There are 3 techniques for PRP preparation: the gravitational platelet sequestration (GPS) technique, standard cell separators, and autologous selective filtration technology, also referred to as plateletpheresis. A small amount of PRP can be obtained in minutes using the GPS technique which is a table-top centrifuge system. For example, 5 ml of PRP volume can be prepared following a 12 minute spin at 3200 rpm using a GPS system.
What Is the Role of Platelet-Derived Biologics?
“Once the PRP is activated, its advocates suggest benefits including restoration of bone and soft tissue, improved wound healing, and a reduction in post-operative infection and blood loss.”
An anticoagulant such as citrate dextrose (ACD) is added where citrate binds calcium and prevents coagulation, whereas dextrose supports platelet metabolism and viability. PRP is stable in the anticoagulated state for 8 hours or longer allowing the blood to be drawn before the operation and used as needed during long surgical procedures. Once PRP is prepared, it must be activated for platelets to release its granules bioactive contents. This is usually accomplished by adding a small amount of topical bovine thrombin and 10% calcium chloride to the PRP.2 Once the PRP is activated, its advocates suggest benefits including restoration of bone and soft tissue, improved wound healing, and a reduction in post-operative infection and blood loss. There has been several publications on the use of PRP for clinical applications in plastic surgery, oral surgery, trauma and orthopaedic surgery, spinal fusion surgery, heart bypass surgery and in the treatment of chronic skin and soft-tissue ulcers.4,5 PRP preparations can be further subdivided into leucocyte-poor preparations (LP-PRP; defined as having a leucocyte concentration below baseline) and leucocyte rich preparations (LR-PRP; defined as having a leucocyte concentration above baseline.
Autologous Anti-inflammatories Preparations (AAIs) With an increasing appreciation that many of the anti-inflammatory factors within blood arise from leucocytes rather than platelets, strategies focussing on concentrating leucocytes or the anti-inflammatory factors they release have been developed. These include platelet-poor plasma (PPP) and AAIs. AAI formulations include Autologous Protein Solution (APS) (nStride) and Autologousconditioned serum ACS (known as Orthokine
in Europe and Regenokine in the US). APS is an AAI that has supraphysiological concentrations of anti-inflammatory factor ILr. APS is produced by obtaining LR-PRP, which is then filtered through polyacrylamide beads producing a high concentration of anti-inflammatory cytokines while ensuring low levels of pro-inflammatory contents. ACS is another AAI which is a cell free serum containing anti-inflammatory factors released from activated leucocytes. ACS is obtained by drawing whole blood and incubating this with chromium sulphate to stimulate the synthesis of interleukin-1 (IL-1) receptor antagonists and other anti-inflammatory cytokines. This then undergoes filtration and centrifugation prior to intra-articular injections to treat osteoarthritic conditions such as knee OA.1
Biological Properties and Activities of PRP Platelets are the smallest of the blood cells, approximately 2 μm in diameter. Theirα granules contain more than 30 bioactive proteins such as Platelet Derived Growth factor (PDGF), Transforming Growth Factors-Beta (TGF-B), Vascular Endothelial Growth Factors (VEGF), among others. These proteins have a fundamental role in haemostasis and tissue healing. The biological properties of PRP are based on the production and release of these multiple growth and differentiation factors when the platelets are activated. Platelets actively begin secreting these proteins within 10 minutes of clotting. Healing of both soft and hard tissue is mediated by a complex array of intra- and extra- cellular events that are regulated by these signaling proteins.5
Safety Profile of PRP PRP preparations are generally safe. However, activation of PRP requires bovine thrombin preparations which has some concerns related to coagulopathies, especially when used in large
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What Is the Role of Platelet-Derived Biologics? amounts. Table 1: Broad categories of Autologous blood products. Autologous blood products
Platelet rich plasma (PRP)
Autologous antiinflammatories (AAIs)
PRP subdivisions
Commercially available separator devices
Leucocyte poorPRP (LP-PRP)
ACP, Arthrex A-PRP, Regenlab Cascade, MTF clearPRP, Harvest PurePRP, EmCyte Endoret (PGRF0, BTI
Leucocyte richPRP (LR-PRP)
GPSIII, ZimmerBiomet Angel, Arthrex GenesisCS, EmCyte Magellan, Arteriocyte, SMART PReP, Harvest
Autologous Protein Solution (APS)
nStride, ZimmerBiomet
Autologous Conditioned Serum (ACS)
Orthokine, Orthogen
In the UK, PRP is classed as an unlicensed human medicine. Therefore, it is subject to human medicines legislation. Recently, there have been some concerns in relation to its unregulated widespread use, so much so that it has come under scrutiny by some professional bodies. The Royal College of Podiatry (RCPod) is instructing its members to stop providing platelet-rich plasma (PRP) therapy to patients with immediate effect; the RCPod is instructing any members who undertake PRP injections to suspend their use while an urgent review of information from the Medical Healthcare Regulatory Authority (MHRA) takes place.6 It is recommended any clinician offering PRP therapy should do so within a clinical governance framework.
Global Market of PRP Despite the lack of sound evidence use of PRP is increasing. The global platelet rich plasma (PRP) market size was valued at USD 627.9 million in 2022 and is expected to grow at a compound annual growth rate of 15% from 2023 to 2030. Platelet-rich plasma usage is witnessing growth owing to the increasing participation in sporting events leading to increasing cases of sports injuries, and an upsurge in cosmetic surgery.
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Increasing research applications of platelet rich plasma (PRP) are also fuelling the industry growth. The growth of PRP treatment in the upcoming years may involve treating the large geriatric population, and in dental health. For instance, in 2020, according to the American Society of Plastic Surgeons, a 25% rise in the use of PRP in cosmetics was observed in the last 4 years.7
Conclusion Orthobiologics and regenerative therapies, particularly PRP, represents an exciting field with multiple potential uses. However, many products with different trade names and descriptions continue to be introduced making the terminology and nomenclature of these therapies ambiguous and difficult to follow. More research trials with linked clinical registries and biospecimen repositories are needed to standardize and substantiate its continued future use.
References 1. Toland GE, Makaram NS, Atzmon R et al. Orthobiologics in the knee. Orthopaedics and Trauma 37:3, 2023. 2. Murray IR SM, De Bari C, McCaskie AW. Orthobiologics: scientific background. J Trauma Orthop 2022;10:48-9As ‘Natural’ treatments, attractive option for both patients and Surgeons/ Clinicians 3. J Alsousou , M Thompson, P Hulley, A Noble, K Willett. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug; 91(8):987-96. 4. Kumar V, Millar T, Murphy PN, Clough T. The treatment of intractable plantar fasciitis with platelet-rich plasma injection. Foot (Edinb). 2013 Jun-Sep; 23(2-3):74-7. 5. Eppley BL, Pietrzak WS, Blanton M. Platelet-rich plasma: a review of biology and applications in plastic surgery. Plast Reconstr Surg. 2006 Nov;118(6):147e-159e. 6. RCPod tells its members to stop providing PRP injections. Royal College of Podiatry. Available at: https://rcpod.org.uk/news/rcpod-tells-its-members-to-stop-providing-prpinjections. [Accessed on 17th June 2023]. 7. Platelet Rich Plasma (PRP) Market Size, Share & Trends Analysis Report By Type (Pure, Leukocyte Rich), By Application (Orthopedics, Sports Medicine, Cosmetic Surgery), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Grand View Research. Available at: https://www.grandviewresearch.com/industry-analysis/platelet-rich-plasma-prp-market. [Accessed on 16 June 2023].
MasterSeries 60 Minutes Interactive All Roads Lead to Healing: Mastering Wound Bed Preparation
from providing services to those not likely to
Global expert
benefit – avoiding under use and misuse
Ms Terry Swanson Vice Chair, International Wound Infection Institute
•
Patient centered: Providing care that is respectful of
Victoria, Australia
and
responsive
to
individual
patients’
preferences, needs and values and ensuring that patient values guide all clinical decisions
Global expert Prof Georgina Gethin
•
Professor of Nursing, Head of School of Nursing and Midwifery, University of Galway
Timely: Reducing wait and sometimes harmful delays for both those who receive and those who give care
Galway, Ireland
•
Person Centeredness and Combining It With Wound Bed Care
Efficient: Avoiding waste, including waste of equipment, supplies, energy, and ideas
• What Is Quality in Healthcare?
Equitable: Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and
In the US, the agency for healthcare research and
socioeconomic status
quality identifies six domains that are considered 1
to be indicators of health care quality. With the application of this with wound care, patients can
•
The key symptoms and experiences associated with a chronic wound
experience high quality and consistent treatment, aiding to their satisfaction and wellbeing during the
This can be divided up into three categories: physical
process of their care.
impact, social impact, and psychological impact. These are all integrated within the person-centred
Care being provided should be:
Supported by
•
Safe: Avoiding harm to patients from the care that is intended to help them
•
Effective: Providing services based on scientific knowledge to all who could benefit, and refrain
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care.2
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation
“The notion of person-centred care offers a vital perspective that patients should be at the centre of decisions made, rather than on the periphery. Clinicians with such wider perspectives will enhance the quality of care for their patients.”
•
Figure 1: interconnected themes of patient impact.
Adherence: Decision to accept, reject or modify their treatment
•
Concordance: Agreement between a clinician and patient on the treatment plan
In comparison to other concepts, such as compliance adherence and concordance, person centred care holds 8 principles, as identified by the Picker Institute at Harvard Medical school. Although not defined as an academic research or set out as policy, the principles had been defined via consultation with the public. These include: •
Continuity and transition
•
Access to care
•
Information and education
•
Respect of patient’s preferences
•
Physical comfort
The notion of person-centred care offers a vital
•
Involvement of family and friends
perspective that patients should be at the centre
•
Emotional support
of decisions made, rather than on the periphery.
•
Co-ordination and integration of care
Clinicians with such wider perspectives will enhance The examination of these decided principles in relation
the quality of care for their patients.
to wound care is important for better treatment and The World Health Organisation (2015) described
care. In regard to access to care, it can be considered
person-centred care as “a paradigm shift toward
for patients with recurrent wounds - such as venous
an approach where people have the education and
leg ulcers or hidradenitis suppurativa - as they know
support, they need to make decisions and participate
when a wound is about to break out, or the early signs
in their own care”.
of it about to, they may become more impatient with the idea of being added to a waiting list, wanting more
Support may consist of social, health service or financial
support.
This
description
from
prompt access the care they require at that time.
WHO
emphasises that it is based on people’s needs and
Information and education in an appropriate format
expectations, rather than a focus on diseases. The
which patients can understand and access freely
approaches and practices that consider the person
is equally important. Evidence shows that current
as a whole, with many levels of needs and goals,
resources for wound care are not widespread and
with these needs coming from their own personal
readily available. The European Wound Management
social determinates of health. Whilst this is a very
Association are contributing to this by providing more
thorough and tasking approach, clinicians can use
patient education.
this approach to improve the wellbeing and results for their patients.
Co-ordination and integration of care can look to the analysis of medical records, for example. It is
•
Compliance: Willingness to follow or consent to
possible for there to be separate medical records
the wishes of another
depending on departments such as dermatology, GP practice, hospital practices, etc. This may include
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MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation
“A wound can be thought of as like an island. An island is affected by what is surrounding it, and under it.”
the continuity of care and transition arrangements.
•
In each study, it was identified that patients
A various set of notes requires coordination and for
with chronic wounds had poorer mental health
it to be integrated properly for the patient. Wound
than their age/ gender counterparts. This was
care practitioners must also be aware of the sensitive nature of analysing these notes - a patient can find
achieved with different measuring scales •
looking at such material to be distressing as they are
99% could walk unaided, serving to be beneficial as mobility and exercise is a factor to promote
not used to seeing it like an experienced clinician is.
healing
Involvement of family and friends regards emotional
•
53% have hypertension (EU)
support,
•
16-20% have diabetes3
but
may
also
include
educational,
appointment arrangements. Physical comfort may be achieved with beds, appliances, and suitable
A group of patients with chronic wounds and the topic
compression wear.
of wound assessment heavily regards looking at a group of individuals with complex health care needs.
European Wound Management Association have
Fit and healthy people do not get chronic wounds;
further evidence for person centred care for chronic
there is one fundamental underlying comorbidity, and
wounds.
at least one underlying factor that is affecting healing. Furthermore, prescribed medications, environmental
Also, impact of patient health and lifestyle factors on
factors, and age, etc.
wound healing: The Island Paradigm •
Stress
•
Sleep
A wound can be thought of as like an island. An island
•
Smoking
is affected by what is surrounding it, and under it.
•
Alcohol
When looking at wound assessment, it can be broken
•
Common medication and illicit drug use
down into further parts:
•
Physical activity
•
Nutrition Figure 2: Holistic approach to wound assessment.
These are the most prevalent risk factors. The Profile of Patients With Venous Leg Ulcers: A Systemic Review and Global Perspective Evidence taken from multiple sources of data produced these key findings on patients with venous leg ulcers complied into a picture of the population we are dealing with: •
Age 47 (Asia)
•
Age 69 (EU)
•
Ulcer size is on average 25.7cm^2 (EU)
•
To 30.95cm^2 (South America)
•
Mean ulcer duration = 13.8 months (EU)
•
To 65.5 months (South America) - Longer, arguably due to various different resources and the structure of services
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Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation
“Many clinicians now begin consultations in a different way, ensuring that patient centred concerns are emphasised. This is expressed via questions asking the patient of their concerns, specific care requests, and establishes a focus on what the patient would like to assess, rather than creating one sided medical goals from a practitioner.”
All of these factors will influence what the wound
6. Assess for treatment infection.
looks like, as well as altering the rates of healing and the risk of further deterioration.
7. Moisture management.
Preparing the Wound to Heal
8. Evaluate rate of healing.
This approach4 looks at wound bed preparation in
9. Edge effect:
terms of updated recommendations. It is shown to be effective as it begins with a person with a chronic
Regards looking at the edge of the wound to indicate
wound, focusing on the patient immediately with
wound status.
this person-centred care approach. Secondly, it looks to identify/ treat the cause of the wound and
10. Organisational support.
identify the patient and family’s centre of concern. Thirdly, determine the ability to heal, before moving
Wound assessment helps to plan treatment, monitor,
on to looking at local wound care. This may include
and evaluate, justify interventions, and in terms of
debridement, inflammation/ local infection, and
enhanced communication.
moisture balance. Wound bed assessment is fraught with a longThe approach suggests ten recommendations for
standing difficulty of it being primarily subjective.
clinicians to instil in their practices:
This is due to the fact it consists of visual inspection and relying on descriptors to help clinicians identify a
1. Treatment of cause:
wound. There are very few objective methods. More of the interventions in wound assessments require
It is important to identify the cause and to treat
technology, and this requires more finance and
it. This may be pressure, moisture associated skin
resources that may not be accessible to everyone.
damage, medical device related injuries, or venous hypertension.
The triangle of wound assessment5 involves analysing three aspects of the wound:
2. Patient centred concerns: •
Wound bed
Many clinicians now begin consultations in a different
Tissue type
way, ensuring that patient centred concerns are
Exudate
emphasised. This is expressed via questions asking the patient of their concerns, specific care requests,
Infection •
Wound edge
and establishes a focus on what the patient would
Maceration
like to assess, rather than creating one sided medical
Dehydration
goals from a practitioner.
Undermining Rolled
3. Determine ability to heal:
•
Periwound skin Macerating
This aspect questions whether is it possible for a
Excoriation
wound to heal or not.
Dry skin Hyperkeratosis
4. Local wound care
Callus Eczema
5. Debride when indicated
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MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation
“Wound bed assessment is fraught with a long-standing difficulty of it being primarily subjective. This is due to the fact it consists of visual inspection and relying on descriptors to help clinicians identify a wound.”
Figure 3:
Figure 4:
Figure 5:
Figure 6:
Figure 7:
Figure 8:
With the wound blocked out in Figure 3, the
By contrast, Figure 5 shows a heel wound from a
surrounding of it can be made clearer. Doing so will
patient with diabetes and history of stroke. There
improve judgement of what the wound is likely to be.
are no areas of surrounding erythema, no signs of infection despite the build-up of thick tenacious
There is dry flaky skin build up, varicose eczema and
slough. The wound presents a well-defined edge,
dryness from prolonged bandaging. There is also
alongside healthy tissue that is merging into the
a fragile periwound area, combined with satellite
wound.
lesions and varicosities. This patient has venous hypertension, long-standing venous leg ulceration.
In a case like Figure 5, the treatment should aim to protect the good tissue that is there via the form of
Figure 4 reveals the wound. In looking into this and
granulation tissue around the top. Removal of slough
assessing the edge of the wound, the potential of
is not recommended at this point. As this patient has
healing can be decided. The edge blending into the
severe peripheral arterial disease, removing slough
wound and lack of definition, alongside the wound
via a scalpel would cause a new wound to open up,
bed itself showing fibrous and bright red friable
causing a rebound necrosis. The primary aim with
tissue, shows there is potential for healing, however
this wound would be to manage the exudate, protect
it requires a renewed approach. A healing wound
underlying tissue, and monitor any signs of infection.
would hold a more defined edge, with areas showing epithelial edge advancement. This is not evident in
Figure 6 presents a different kind of wound edge.
this particular wound.
It holds a purple hue on its surroundings, with a dark dull red. The issue of colour is shown here as a bright red indicates a good red granulation tissue;
92
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MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation
“Adequate wound cleansing is vital for all wound cases. Utilisation of a good irrigation fluid to cleanse the wound, and potentially drinkable regular tap water, will aid in the healing process.”
Figure 9: Periwound assessment.
take a long time. In this patient, the likelihood of healing is very small, primarily due to many social circumstances, but due to multiple underlying comorbidities. The wound edge shows a highly fragile and friable state. Underneath it, there is a delicate and inflamed tissue, beside areas of epithelial that are popping up indicating that healing is occurring. However, there is a large build-up of pseudemonas, maceration and inflammation. There is copious exudate from the wound that is pouring down and gathering around the ankle.
description can become problematic. Figure 6 is red, however as it is a dull red it is a poor indication. The
Treatment would be to treat underlying infection,
entire wound is covered in fibrous tissue, but it is not
irrigation to reduce bacterial burden, as well as extra
slough. The edge is ragged and also very thin.
moisture absorbing dressings around the ankle with protection of the periwound area. Regular wound
This patient has rheumatoid arthritis. With flare
dressings would also be required. Changing absorbent
ups, the wound would become enlarged. Here, the
pads to soak up exudate would be beneficial. The
deterioration is due to rheumatoid arthritis and drug
patient in Figure 8 refuses compression therapy
therapy the patient was undergoing.
despite being eligible for it.
The wound is a healable wound and can be managed
Wound edge assessment in Figure 8 shows a very
by managing exudate from the wound, managing
varied result. This evidence supports the fact that
inflammation around the wound, and managing local
a challenge in wound care includes the fact that a
wound infection.
wound is not a uniformed island and is different depending on the focus point of the wound.
Figure 7 presents a patient with a common kind of venous leg ulcer. There are no signs of infection or
Figure 9 clearly illustrates an infected wound, with a
inflammation around the wound. The wound bed
large maceration of periwound skin due to excessive
itself presents bubbly like granulation tissue – ideal
moisture from the wound. There is also a build-up
tissue accompanied with a well-defined wound edge
of slough, surrounded by a friable edge that is not
that is not inflamed nor slopping into the wound itself.
defined but inflamed.
There is some fibrous tissue, however no build-up of slough. Management of a simple dressing to protect
In this case, gentle irrigation to clean the wound
the tissue combined with a management of wound
bed and reduce the bacterial burden, high quality
exudate would be ideal.
protection of the periwound skin, and adequate moisture control would be sufficient for management.
Adequate wound cleansing is vital for all wound cases.
Compression therapy should be held off until the
Utilisation of a good irrigation fluid to cleanse the
infection has been resolved.
wound, and potentially drinkable regular tap water, will aid in the healing process. Figure 8 presents a highly extensive venous leg ulceration. It is a healable wound; however, it may
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93
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation In regard to protecting the peri wound area it is
The human microbiome is a complex system. On some
important to:
occasions the microbiome works together to reduce pathogenic bacteria - not all biofilms are necessarily
• •
Protect it from Moisture Associated Skin Damage
bad. This is only the case when it becomes pathogenic
(MASD)
and subsequently forming hyperinflammation leading
Cleanse
with
hypoallergenic
non
irritating
to a chronic and recant wound healing process.
products •
Avoid
products
containing
preservatives,
This shows an imbalance where there are too many
quinoline, PVP iodine
negative components that are not conducive to
•
Tepid water only if used
wound healing, and such destructive enzymes and
•
Opt for the utilisation of no rinse products
toxics can worsen the wound condition. It causes
•
Gently dry the skin
for the wound to change from being host centric -
•
Carefully consider wound dressings
controlled by the body’s physiological processes - to
•
Use skin protectant products
now more bacteria centric. This imbalance decreases the amount of growth factors. Additionally, the
To conclude, wound bed preparation involves
destructive lytic enzymes and free radicals affect cell
patient assessment, assessment of the aetiology
proliferation and wound healing capability.
of the wound, healing assessment, and wound bed assessment.
The
nutrient
rich
exudate
from
persistent
inflammation assists in the bacterial cause and makes
Wound Bed Preparation
that environment more hostile, therefore affecting immune recognition and the healing process.
Principles of Biofilm Management Biofilm Consensus Group 2017 findings Planktonic is not the normal state for bacteria. It is considered as non-attached, free floating and
In a consensus group from 2017, signs and symptoms
replicating. It goes into great density/ virulence and
were established:
becomes an acute infection. Antibiotics are effective for planktonic because they are replicating.
•
Failure of appropriate antibiotic treatment
•
Recalcitrance
themselves, to the dressing, or below the wound
to
appropriate
antimicrobial
treatment
Biofilm is when they attach; they can attach to •
Antibiotics do not function on non-replicating bacteria. Biofilm decreases myotic activity
surface. When they become attached, they can aggregate. Aggregation can enable communication known as quorum sensing.
•
When they begin to mature, they become more
•
Recurrence of delayed healing on cessation of antibiotic treatment Patients with local infection or biofilm infection
tolerant to most antimicrobial agents. The host
are often on a 10-week cycle, in which once the
defences’ efficacy becomes reduced due to the
antibiotic treatment has stopped, symptoms
protection of the extracellular matrix because the
come back rapidly
centre of a mature biofilm may be slightly hypoxic, and the myotic activity – replicating – has decreased.
•
Delayed
healing
despite
optimal
wound
management and health support
Therefore, antibiotics would not become effective. •
Describes when a patient has a healable wound
The body recognises that the biofilm is there, and
but delayed healing despite optimal treatment –
therefore it promotes a chronic inflammation.
diagnosis and targeted therapy
Evidence shows that it can be over 1000x more tolerant to antibiotics. Biofilms have primitive
•
Increased exudate/ moisture
circulatory systems that facilitate uptake of nutrients
(when) doing weekly assessments, an increase in
and removal of metabolic products. These nutrients
moisture is a negative indicator
can be from edema and fluids, hence why moisture
94
management is vital. This causes an increase of
•
Low-level chronic inflammation
exudate when there is a biofilm.
•
Low-level erythema
•
Patients
may
sometimes
be
prescribed
There can also be gene transfer of microbes within
antibiotics despite it being an inflammation
the biofilm, and this may be polymicrobial.
instead of an infection
Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation •
Poor granulation/friable/hyper granulation
•
Secondary signs of infection
Figure 10:
Figure 10 shows an updated version of biofilm based wound care. It upholds consistent instructions of the disruption of the biofilm and the prevention of recolonisation. With this scheme, the signs of persistent inflammation must be monitored. Presence of slough and necrosis may not necessarily be relevant to biofilm, as it may be a result of other things such as circulation (for necrosis) and moisture balance (for slough). Management of Biofilm: Common Ingredients •
Knowing aetiology
•
Standard of care for that aetiology
The International Wound Infection Institute (IWII)
•
Wound and periwound cleansing.
coined the term ‘wound hygiene’. It was expanded
•
Debridement of wound, edges and periwound
and explored on within the document, providing a
•
Once the wound is prepared then proactive
consensus of what wound hygiene entails. It involves
management to prevent microbial attachment
an anti-biofilm strategy: what to look out for, and how to handle the intensity of those interventions.
Consistency in the recommendations of biofilm: Outline of Wound Hygiene •
WBP – Wound Bed Preparation, since 1990s.
•
Time –since early 2000
1.
Cleanse the wound and periwound skin
•
BBWC - Biofilm based wound care
2.
Debridement
•
Step-down step-up paradigm – published 2017
3.
Refashion the wound edge
•
Wound Hygiene – published 2019
4.
Dress the wound
These documents provide a synthesis of the latest
The wound hygiene concept has continued to evolve;
research and evidence. They are also patient
it began with the wound itself and continued to
centered, and when adapted locally they can provide
expand. The wound healing framework includes
cultural sensitivity and awareness.
assessment, management of the wound via the four steps of wound hygiene, and monitoring to ensure
As they are reviewed and authored by clinicians
the cycle of healing continues.
for clinicians the majority are free for download or feature a low fee requirement to increase
The
accessibility. Additionally, they can be translated into
contamination,
many different languages.
spreading infection and systemic. Due to the usage
wound
infection
continuum
colonization,
consists
localised
of
infection,
of the term ‘critical colonization’ in 2008, localised has Using evidence-based practices in documents can
become asterisked.
be highly beneficial due to the issues presented by disparity in how people are managing wound
The continuum became updated in 2016 via rigorous
bed cleansing globally. As there is varied practice
methodology. Figure 11 displays this version, with
throughout the world, these documents detailing best
terminology about increasing microbial virulence in
practice and guidelines provide a helpful framework
green, and there is also a biofilm arrow included at
for people to be apply to their own clinical practices.
the top.
They may also be used to update policies and
The intervention strategy developed with changes to
procedures; accrediting the clinic with higher quality
reserve topical anti-microbials for when there is a local
references and data as the latest evidence is being
infection, as well as saving systemic antimicrobials.
implemented.
The term critical colonization had been removed, saving
systemic
antimicrobials
for
spreading/
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95
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation Figure 11:
Figure 12:
Figure 13: Evaluation of an infected wound.
systemic infection. This enables good stewardship of antiseptics and antimicrobials. The wound infection continuum became updated further in 2022 (Figure 12), again via rigorous methodology.
This
edition
features
signs
and
symptoms under the relevant terminology. Local Infection: Infection Contained within the Wound Bed Covert, also known as Secondary S&S infection: •
Delayed healing or increased size of wound
•
Unhealthy granulation tissue
•
Increased Exudate
•
Suspected Biofilm
Overt, Classic S&S infection:
Spreading Infection, the invasion of surrounding and deeper tissue by ineffective organisms:
•
Erythema within 2 cm
•
Purulent exudate
•
Increasing pain
•
Local warmth and oedema
•
Erythema becomes greater than 2 cm, as shown in Figure 13
•
Cellulitis
•
Lymphangitis
•
Enlargement of the wound and/or satellite ulcers
Covert is aligned with the biofilm and the secondary signs of infection such as delayed healing, increased
Treatment would not solely consist of therapeutic
wound size, and unhealthy granulation tissue.
cleansing and topical antimicrobials, but also includes systemic antibiotics.
Overt are the classic signs of infection, including increased pain, oedema, and there may be some exudate. It is important to note that this is still contained within the wound bed. Treatment is proactive as it involves therapeutic cleansing and consideration of topical antimicrobials.
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MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation Figure 14: Determining infection vs induration of a wound.
edges to prevent the microbes that are on the periwound surface returning to contaminate the wound. The intensity depends on the healing phase and condition the wound is in. The importance of wound cleansing: •
Decreased antibiotics prescribing
•
Alteration of wound environment
•
Disruption of biofilm
•
Improved efficacy of topical treatments
•
Prevention of escalating from local infection to spreading of infection (when conducted in early phases of wounding)
•
Maybe saving a limb or life
It is vital to ensure that when doing therapeutic irrigation that there are the correct pounds per square inch of 4-15 psi. With loose or necrotic tissues, a higher psi would be required, and it may be lowered once it is clean or healing. Therapeutic irrigation must be carried out with personal protection.7,8 Options for cleaning the periwound and skin: •
Portable water and wash cloths
•
Commercial wipes - often used in podiatry
A challenge presented in wound care is the confusion
department due to its smaller body surface
between infection and inflammation. Figure 14
•
Glove fingers
presents an inflamed wound that may be caused
•
Forceps
from contact with the dressing and a reaction, or it
-
often
used
for
scraping
off
hyperkeratotic tissue
may be the wound fluid that is now interacting with
•
Sponges
the skin in a negative way causing contact dermatitis.
•
Utilisations of cleaning agents – provides
By understanding the cause, the difference can be
synergistic effects that are highly beneficial6
made better. Tips for Practice When cleansing wounds, it is effective to adopt a thorough and comprehensive approach. It is possible
•
to remove non-viable tissue and clean it up to enable the dressings to directly contact the wound surface
the periwound •
and perform better. Once the biofilm and micro
Don’t contaminate the water. If using a bowl of warm water, do not put the cloth that touched
environment has been disrupted, the dressings have better access.
You can be soaking the wound while you clean
the skin back into the water •
You can apply pH neutral/ antiseptic skin cleanser on gloved hands, massaging it in and
Helpful Tips for Therapeutic Wound Cleansing
then washing with potable water •
The patient can shower but the limb should be
When deciding what to cleanse with, it ultimately
bagged first, and then cleaned. This allows for
depends on what is there available, as well as the
the limb to be protected from the contaminates
type of wound – such as healing or infected. Infected
and microbes from the upper body
wounds can use antiseptics as its design is for this purpose. Cleaning occurs with each dressing change,
In the event the patient has a very dry scaly leg, it may
and anywhere there has been a dressing. This area
be the case that the leg has dried up after removing
should be cleansed about 20 cm from the wound
the compression wrap.
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MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation A good method to handle dry scaly wounds is as
its full potential of healing by being cleansed.
follows: A common misconception is that there is a difference • •
Create a soak by pouring solution on the wound,
between mechanical cleansing and debridement.
this provides it with contact time
However, they are essentially the same thing; both
Using gloves and with a combination of a pH skin
methods achieve the same goal. The components
cleanser, massaging the wound helps soften the
illustrated here may also be sued to be applied to
skin
negative pressure wound therapy.
Prevention is highly important in wound care to
Figure 15: Types of wound exudate.
ensure the wound does not become worse. Wound cleansing should also be combined with protecting limb skin health. The Management of Hyperkeratosis of provides easy strategies for cleansing and providing emollients. Hyperkeratosis is essentially a breeding ground for microbes and the goal is to reduce this to
Serous
Seroanguineous
Sanguineous
Seropurulent
Fibrinous
Purulent
Haemopurulent
Haemorrhagic
prevent infection. Rinsing, cleaning, or scrubbing a wound: It is important to clean a wound, and if it is an infection it would need to be scrubbed. In order for this to happen the synergistic effect and combination of an agent and mechanical device would be needed. •
Sterile water and normal saline have limited ability to manage microbes. If this is the only resource available, it is important to combine
•
•
•
•
this with more aggressive mechanical action
Figure 15 displays the different types of exudate. In
Antiseptic solutions assist in making the cleaning
regard to the viscosity, understanding the viscosity/
more effective. They can kill and or disrupt the
consistency can influence the effectiveness of
bacteria in the wound
dressings.
Surfactants make the job easier and more effective due to the fact it breaks surface tension
It is also beneficial to inspect the old dressings and find
and makes removing debris more effective
out when it was last changed. A dressing saturated in
Using mechanical aids improves the goal of
a matter of hours will not last for three days. This can
the activity. Using gauze is acceptable but
help decide the frequency of wound dressing change,
multiple would need to be used to prevent cross
or the absorbency of the dressing. Moisture needs to
contamination
be balanced, and the type of fluid and dressing used
Therapeutic cleansing is rigorous cleansing of
will aid in wound assessment.
wounds and periwound to remove: Assessing the Wound Exudate • •
Excess exudate, debris, remnant dressing, nonviable tissue
•
Inspect the used dressing for any leakage
Improve assessment, as components of the
•
Determine the amount of wound exudate in
wound are defined more clearly •
Disrupt and remove microorganisms
•
Wound cleansing should be done with each
both wound and dressing •
Assess the colour, viscosity, and odour of wound exudate
dressing change When managing and treating infection, it is important During this process it is important to be aware of the
to be mindful about prescribing antibiotics due to
fact that some cultures do not advocate cleansing.
antimicrobial wounds. It is still necessary to carry out
Due to the importance of cleansing, it is imperative
wound preparation even when prescribing antibiotics.
to teach the patients why it is needed and to have
The five-step guide to wound healing suggests key
cultural sensitivity. This can be done by proving the
warning signs including:
evidence and conveying how the wound needs to have
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Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation •
A healable wound is not healing
delayed by external clinicians until the wound has
•
Changes to the patient’s overall health or
significantly worsened:
wellbeing (fever, etc.) •
Increased amounts of exudate, discoloration,
•
odour
Incorrect
diagnosis,
and
requirement
for
specialised clinics
•
Deterioration of wound edge or periwound skin
•
Requirement for advanced therapy
•
Hyper-granulation - discolouration of the wound
•
Growth factors
bed, granulation tissue, fragile wound bed tissue •
Biofilm should be suspected if a local infection
When wounds are not healing, or it is being
is
significantly delayed, clinicians can act as a facilitator
non-responsive
to
topical
antimicrobial
treatment
of advanced care, and work with other specialists to achieve the end goal. This may involve dieticians,
The classification system from the IWGDFU can be
podiatrists, and vascular surgeons. Sharing the
mirrored with the IWII classification system to portray
workload and collaborating will ensure the patient
consistent information and resources. This evidence
is provided with well-rounded specialised care for
shows how accurate resources and information are
optimal results. Moving towards a multidisciplinary
highly important to ensure clinicians follow a well-
clinic can provide high benefits for patients appearing
established routine.
with non healing wounds.
Why are wounds therapeutically cleansed?
As the healing trajectory becomes closer, more gentle methods can be adopted, and the need for sharp
•
To disrupt the biofilm
•
To cleanse excess exudate from the wound
•
To prepare the wound bed for cultures and/or
This biofilm suppression process, as established by
the wound dressing
Stephen Percival (2022), provides a process of how
•
To assist in wound assessment
to remove biofilms, similar to the existing concept
•
Removing debris, foreign bodies, remnant
therefore showing the great consistency between
dressing, and loose non-viable tissue
resources to enable high quality care over different
To decrease the bioburden
clinics.
•
selective reduce.
The ‘Step Down Step Up’ biofilm based wound care
It is important to note that sharp debridement
strategy places importance on the requirement to be
alone cannot solely achieve biofilm suppression.
less tolerant of non-healing wounds.
Cleansing is still necessary, as well as a repetition of debridement- depending on the depth of the biofilm
It is important to understand what the diagnosis is. If
below the surface level.9
this is unclear it is necessary to carry out a referral or use a clinicians that can provide this diagnosis.
Antimicrobial
Aggressive debridement and empirical treatment, as
Antimicrobial is an umbrella term used for antibiotics,
well as a standard of care should be implemented. In
antiseptics, and disinfectants.
doing so, the first week should enable an improved quality of living for the patient, such as decreased
•
Antibiotics
are
selective
agents
against
exudate and decreased odour. Whilst wound healing
replicating bacteria to kill or reduce them. It can
may not necessarily occur yet, a healing trajectory
be administered systemically or topically. With
should be established within the first month.
biofilms, there is a decreased activity of this, hence why they are not effective
With an expected healing timeline formed, the choice
•
Antiseptics are chemical agents that can be
to step them down to standard care could be made,
applied topically to a skin or wound. The new
or potentially step them up for more advanced
generation of antiseptics have low cytotoxicity
therapy options, as shown in the graph. With early
and selectivity. They are designed to inhibit and
intervention, this process is made possible.
kill the multiplication of microorganisms •
Disinfectants are not used on human wounds as
In cases where a wound does not benefit from this
they are toxic to human cells. However, they are
process or early intervention, it must be reassessed.
used to surfaces prior to putting equipment on
This also involves cases in which the diagnosis was
top. They are relatively non-selective agents with
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99
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation multiple sites of actions that kill a wide range of
•
Semi-controlled environment
microorganisms •
Wound cleansing in a residential facility
Dressing Types, Indicators and Application: • • •
Medicated: such as honey, silver, antiseptic, and
Option for a shower would require same instructions as acute care settings
iodine
•
Assess risk factors
Non-medicated: work via actions, such as
•
Share or individual shower area
microbe binding, sequestering, osmotic or hypertonic which include rinsing, moisture
•
Wound cleansing in the home environment
donating, or absorbing if it is wet •
Passive: drying with gauze or non-adherent
•
Assess risk factors
•
Negative Pressure Wound Therapy (NPWT):
•
Health status
such as dressing, without cannister, disposable,
•
Repeated infections
instillation, and incision
•
Capability of doing the task independently
•
Cellular and tissue-based products: matrix and
or requires assisted care
scaffolding and growth factors Wound cleansing considerations:
•
Cleanliness of the home
•
Potable water
•
Equipment available and condition
•
Same instructions as previous environments
•
If cleaning wound and periwound once
•
Patient’s health related factors
•
Wound characteristics
shower completed options are in the
•
Availability of products/ equipment
shower or using a container
•
Complexity of the wound dressing procedure
•
Environment of where the wound dressing
Showers are encouraged for patients, however if
procedure will occur – such as unpredictable
there are repeated infections it is advised to keep the
home settings, or the controlled clean hospital
wound covered, irrespective of if it gets wet, as this
setting
can be changed after the shower.
•
Local policies and procedures
•
Wound cleansing in an acute hospital inpatient
thought should be evident in practice to ensure
setting:
cleanliness is achieved.
When wound cleansing in a home setting, care and
•
If
having
a
shower
(based
on
risk
Choices of Aseptic Technique
•
Cover the wounds during general hygiene.
Aseptic technique is based on:
•
After general hygiene patient removed
assessment)
•
from shower area if in shared shower
•
Sequencing
arrangement, remove the dressings and
•
Environmental control
cleanse the wound and periwound.
•
Hand hygiene
If single shower and minimal risk factors
•
Maintenance of aseptic fields
after general hygiene remove dressing
•
Equipment requirements
in the shower and cleanse (complete the
•
PPE
dressing application elsewhere) •
Use clean or disposable cloths to pat dry the area
•
Wound cleansing in a clinic or GP •
Option to remove their bandages/ dressings at home and cleanse prior to coming in (check risk factors and home environment)
•
Same principles for cleaning the wound and periwound, cover wound in shower
•
Either bring in the old dressing, take a photo or describe how the old dressing looked
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Wound Masterclass - Vol 2 - December 2023
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation Figure 16: Value-based healthcare.
The Standard Aseptic Technique
impact over an inexpensive option will prove itself to be the better option. This is due to the way in which
The concept of standardizing care for wounds in
an inexpensive option can add up, as opposed to the
different environments and patients has many
lower frequent costs of better value options.
challenges and is not seen to be suitable for clinicians wanting to hold a patient centric approach in their
Wound Hygiene and Health Economics
clinics. There are many risk factors, for example if the patient is severely immunocompromised, greater
When the recommended antiseptics and treatment
precautions are necessary. Similarly, in a home
programs are used, then the antibiotic antimicrobial
environment or controlled environment, there are
usage is reduced, as well as the length of treatment
different precautions and factors to consider. This
therefore providing more wound free days. This
also includes access to resources and equipment
results to an overall reduced price of therapy.
such as complex stainless-steel trolleys or dressing
Evidence in trials, product evaluation and case studies
trays. Following a patient centred approach would
all indicate that wound bed preparation provides
enable consistent quality of wound care depending
good health economics.10
on the circumstance, over standardizing and creating a rigid approach that will not be beneficial nor
Wound Bed Preparation for What You Can and Can’t
optimise results.
See.
Value Based Healthcare
Figure 17 is an augmented assessment using a fluorescent device. This helps to improve cleansing. In
When looking at the costs of wound care, it is very
a study showing the benefits of improved cleansing,
important to see the value in the option. Figure 32
there was:
portrays option B being cheaper, but causing to be more cost ineffective as it causes more later issues.
•
33% decrease in antimicrobial prescriptions
The value outweighs the initial cost point of the
•
49% decrease in prescription of antimicrobial
option.
dressings •
The frequency may also shift which option is cost effective. A high value product that can have a better
23% increase in wound healing rates within 12 weeks
•
2% decrease in amputation rate
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101
MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation This evidence shows the drastic benefits of
Figure 18: Immunofluorescence aiding in evaluation of a wound.
improving cleansing and conducting wound bed preparation in one year. Key Points To conclude, it is important to note that: •
Every wound dressing procedure matters
•
What you do or don’t do may affect the outcome of wound healing in the short term or long term
•
Assessment and diagnosis are key to providing appropriate and targeted therapy
Invest in healing by investing the time to: •
Provide aseptic technique or subscribe to the local wound infection and prevention protocols
•
Thorough
assessment
of
the
wound
and
wound/
periwound •
Therapeutic
periwound
cleansing/ debriding and cleansing •
Appropriate
wound
dressing
based
wound
goals
on
and
selection patient
preferences •
Monitoring
progress
and
making
appropriate referrals
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Wound Masterclass - Vol 2 - December 2023
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