May 2012

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Today’s ®

Contemporary Approaches to Wound Clinic Management

Managing

the Pain

Focus On: Methods & Modalities Wound Bioburden • Neuropathy

Also in This Issue: Business Briefs Clinician’s Report: NPWT

May 2012 www.todayswoundclinic.com

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THE SYMPOSIUM ON ADVANCED WOUND CARE

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TODAY’S WOUND CLINIC® (ISSN 1938-6311), is published by HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355.

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Subscriptions: TODAY’S WOUND CLINIC® annual rates for US subscriptions: $99.00 annual; single copies, $39.00.

Caroline Fife, MD, FAAFP, CWS, and Co-Editor of Today’s Wound Clinic

Dot Weir, RN, CWON, CWS, and Co-Editor of Today’s Wound Clinic

Christopher A. Morrison, MD, FACHM, CWS

Kathleen D. Schaum, MS

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Valerie Sullivan, PT, MS, CWS

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Today’s Wound Clinic® May 2012

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Table of Contents

Today’s ®

Volume 6, Number 4, May 2012

Volume 6, Number 4 www.todayswoundclinic.com

Feature Articles 12

D ecreasing Pain & Improving Quality of Life: Clinical Strategies

Clinical Editors and Founding Board Caroline E. Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS Founding Editorial Board Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS Managing Editor Joe Darrah jdarrah@hmpcommunications.com Web Editor Samantha Alleman salleman@hmpcommunications.com

Wound Bioburden: Providing

Infection Control While Managing Pain Effective infection control is necessary not just for sanitation and safety concerns, but to help patients manage pain effectively.

Dot Weir, RN, CWON, CWS; and Pamela G. Unger, BS, PT, CWS

Business Staff Executive Vice President Peter Norris pnorris@hmpcommunications.com VP/Group publisher Jeremy Bowden jbowden@hmpcommunications.com

28 E-Stimulation: An Effective Modality

Associate Publisher Kristen J. Membrino kmembrino@hmpcommunications.com

Facilitate Wound Healing Among those who utilize it, electrical stimulation is known to be a costeffective, therapeutically efficacious wound healing accelerator.

Pamela Scarborough, PT, DPT, MS, CDE,

CWS, CEEAA; and Luther C. Kloth PT,

MS, FAPTA, CWS, FACCWS to

Featured Departments

May 2012

Editorial Staff

for Chronic Wound Patients A comprehensive approach is needed in order to accurately assess pain and establish beneficial management strategies.

Kevin Y. Woo, PhD, RN, FAPWCA

20

SALES ASSOCIATE Sydney Slater sslater@hmpcommunications.com Classified advertising Associate Tara Fields tfields@hmpcommunications.com

Univers 57 Condensed

6 Business Briefs

Reimbursement for Outpatient

33

38

46

Biophysical Procedures and Equipment Kathleen D. Schaum, MS

83 General Warren Boulevard, Suite 100, Malvern, PA 19355

n Inside Look at Intellicure Inc., A The Woodlands, TX

Editorial Correspondence should be addressed to Managing Editor, Today’s Wound Clinic®, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-0500 /Fax: (610) 560-0502.

Clinician’s Report Negative Pressure Wound Therapy

TWC News Update FDA Issues Diabetes Drug Warning

Departments

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Industry Insider

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Editorial policy: TODAY’S WOUND CLINIC® seeks to provide practical, timely insight into clinical and operational issues inherent to the success of an outpatient wound center. Program Directors, Medical Directors, and Clinical Managers (including Nurse Practitioners and other professional wound care providers across multiple disciplines) will benefit from the interactive nature of feature articles and regular departments that address medical and practice management options and perspectives affecting fiscal and, most importantly, patient outcomes of wound clinics. Articles from knowledgeable, experienced practitioners are invited and will be subject to Editorial Board review.

Editorial Board Introduction Editor’s Note Ad Index

5/4/12 5:35 PM

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Please plan to visit our booth #1324 at WOCN

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Precious life – Progressive care 1547741 A 0112 © 2012 Federal law restricts this device to sale or rental by or on the order of a physician. Avance Dressing Kits distributed by Medela, Inc. Medela and Invia are registered trademarks of Medela Holding AG. Liberty is a trademark of Medela, Inc. Avance is a registered trademark of Molnlycke. Medela, Inc. 1101 Corporate Drive, McHenry, IL 60050, USA Phone: 1 877 735 1626 Fax: 1 815 307 8942 suction@medela.com www.medelasuction.com

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introduction

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any of us recently returned from SAWC Spring in Atlanta, and it definitely lived up to the expectations we all had! The educational and scientific sessions were outstanding, the convention venue was spacious, the Georgia Aquarium was beautiful, and the networking opportunities were plentiful! The meeting lived up to the honor that the state of Georgia bestowed by proclaiming the month of April “Chronic Wound Care Month.” Please remember to save the dates of May Dot Weir 2-5, 2013 (SAWC Spring in Denver) and Sept. 12-14, Co-Editor of TWC 2012, (SAWC Fall in Baltimore). This meeting will feature a wound center track, so it’s a perfect, smaller (but growing!) meeting that offers the same quality education and networking we all look forward to.

The issue of Today’s Wound Clinic that you’re reading focuses on an inescapable aspect of wound management — pain. Our patients present with pain at varying degrees and with varying tolerances, providing clinicians the challenge of objectively addressing pain within the limits of licensure, ethics, and conscience.

We know that many of our patients have pain that they arrive with, and we unfortunately conduct mandatory procedures that could add to their pain. My significant bias is that we must believe our patients’ pain is what they say it is until proven otherwise, and that we have an obligation to mitigate additional pain to the extent possible while providing some means of pain management for the patient between clinic visits — whether prescribed by the physicians in the clinic, arranged through the patient’s primary care provider, or made available through referral to formal pain management. From a procedural aspect, the use of topical or injectable anesthetics, depending on the degree of the procedure to be performed (eg, minor debridement versus major or tissue biopsy) is imperative. “Verbal” anesthetics such as “I’m almost done,” “It’s ok, it’s ok,” or “hang in there” are never effective and can undermine a patient’s trust as well as potentially cause them to not return for follow-up care due to the fear of pain. Developing a plan for pain management to be shared with patients during an initial visit can go a long way toward maintaining trust. Other helpful practices include outlining how pain will be managed, assuring that painful procedures will be in the patient’s control (and stopped if intolerable), and having the patient sign a pain “contract” to set realistic expectations and an understanding from the beginning.

To that end, we have some very informative articles in this issue covering diverse aspects of care and pain management. In “Decreasing Pain & Improving Quality of Life: Clinical Strategies for Chronic Wound Patients,” Kevin Y. Woo, PhD, RN, FAPWCA, discusses how to assess, measure, and monitor a patient’s pain in order to provide care accordingly. A collaborative article between myself and fellow TWC editorial board member Pamela G. Unger, BS, PT, CWS, and Joe McCulloch, PhD, PT, addresses wound bioburden and increasing colonization as a potential source of pain as well as topical modalities that reduce bioburden and potential for additional pain. Additionally, TWC editorial board member Pamela Scarborough, PT, DPT, MS, CDE, CWS, CEEAA, and colleague Luther C. Kloth PT, MS, FAPTA, CWS, FACCWS, feature an introspective look at electrical stimulation as a modality to facilitate wound healing. Our Clinician’s Report takes a peak at the ever-growing category of negative pressure wound therapy.

Wishing you all a wonderful spring and summer!

Dot Weir, RN, CWON, CWS, co-editor; dorothy.weir@hcahealthcare.com

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83 General Warren Boulevard, Suite 100, Malvern, PA 19355 © 2012, HMP Communications, LLC. All rights reserved. Reproduction in whole or in part prohibited. Opinions expressed by authors, contributors, and advertisers are their own and not necessarily those of HMP Communications, LLC, the editorial staff, or any member of the editorial advisory board. HMP Communications, LLC is not responsible for accuracy of dosages given in articles printed herein. The appearance of advertisements in this journal is not a warranty, endorsement or approval of the products or services advertised or of their effectiveness, quality or safety. HMP Communications, LLC disclaims responsibility for any injury to persons or property resulting from any ideas or products referred to in the articles or advertisements. Content may not be reproduced in any form without written permission. Reprints of articles are available. Contact HMP Communications, LLC for information.HMP Communications, LLC (HMP) is the authoritative source for comprehensive information and education serving healthcare professionals. HMP’s products include peer-reviewed and non-peer-reviewed medical journals, national trade shows and conferences, online programs and customized clinical programs. HMP is wholly owned subsidiary of HMP Communications Holdings LLC. Discover more about HMP’s products and services at www.hmpcommunications.com.

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businessbriefs

Reimbursement for Outpatient Biophysical Procedures and Equipment Kathleen D. Schaum, MS Information regarding coding, coverage, and payment is provided as a service to our readers.

Every effort has been made to ensure the accuracy of the information. HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment will be received.The responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

A

s discussed by Pamela Scarborough, PT, DPT, MS, CDE, CWS, CEEAA; and Luther Kloth, PT, MS, FAPTA, CWS, FACCWS in “EStimulation: An Effective Modality to Facilitate Wound Healing” on page 28, manufacturers have developed equipment to provide biophysical treatments in outpatient settings and by patients at home. Physicians who believe these treatments are necessary to manage chronic wounds and accompanying pain must understand affiliated coding, Medicare payment, and coverage guidelines (ie, indications, limitations, documentation requirements, etc.).

As we have discussed in this column, the “devil is in the details” when it comes to reimbursement for biophysical procedures and equipment. Providers should read pertinent Medicare National Coverage Determinations (NCDs), their Medicare contractor’s pertinent Local Coverage Determinations (LCDs), and the medical policies from the top 20 private payers in their wound care practice.

This column will provide a brief coding, Medicare payment (see tables 1 and 2), and coverage overview of the most commonly ordered biophysical technologies.

CAUTION: If you choose to use any of these biophysical technologies, you must thoroughly read the pertinent NCDs,

6

LCDs, and medical policies. Those specific policies may have differing coverage guidelines than provided in this overview.

BIOPHYSICAL TECHNOLOGIES USED IN OUTPATIENT SETTINGS 97024 Diathermy (ie, microwave) Medicare NCDs are written for diathermy and pulsed wave diathermy.

Indications for Diathermy and Pulsed Wave Diathermy: • Osteoarthritis, rheumatoid arthritis, or traumatic arthritis • Strain or sprain • Acute or chronic bursitis • Traumatic injury to muscle, ligament, or tendon resulting in functional loss • Joint dislocation or subluxation • Treatment for a post-surgical functional loss • Adhesive capsulitis • Joint contracture.

Limitations for Diathermy and Pulsed Wave Diathermy: • Asthma • Bronchitis • Any other pulmonary condition.

Utilization Guidelines for Diathermy and Pulsed Wave Diathermy: • Only 1 unit is covered per date of service, per discipline.

• If no objective and/or subjective improvements are noted after 6 treatments, a change in treatment plan (alternative strategies) should be implemented,or documentation should include the rationale for continued diathermy.

Documentation Guidelines: Documentation must clearly support the need for diathermy for more than 12 visits.

Documentation for each diathermy/ pulsed wave diathermy should include: • Rationale for use of modality

May 2012 Today’s Wound Clinic®

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• Area(s) being treated • Response of patient to treatment • Objective clinical findings/measurements to support the need for a deepheat treatment • Subjective findings to include pain ratings, pain location, activities that increase or decrease pain, effect on function, etc.

• Functional progress at reassessment and discharge. If there’s no progress, a reason and/or an alternative treatment strategy should be documented.

97026 Infrared Therapy Devices (to one or more areas) A Medicare National Non-Coverage Determination states the Centers for Medicare & Medicaid Services have determined the use of infrared therapy devices and any related accessories is not reasonable and necessary. Therefore, the use of infrared and/or near-infrared light and/or heat, including monochromatic infrared energy, is non-covered for the treatment, including the symptoms such as pain arising from diabetic and/or nondiabetic peripheral sensory neuropathy, wounds and/or ulcers of the skin, and/ or subcutaneous tissues.

If physicians order this treatment for their patients, they should inform the patients that the treatment is not covered

by Medicare and that the patient will be responsible for the cost of the treatment.

97028 Ultraviolet (to one or more areas) Most Medicare contractors address this technology in their LCDs. Indications: • Ultraviolet treatment is generally used for patients requiring the application of a drying heat.

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businessbriefs Table 1. Medicare Payment Rate for Biophysical Therapies

CPT®1 Code

2012 National Average Non-­Facility Medicare Allowable

2012 National Average Patient Coinsurance

97024

$6.47

$1.29

97026

$5.79

$1.16

97028

$7.15

$1.43

97032

$18.38

$3.68

97035

$12.25

$2.45

G0281

$13.27

$2.65

G0329

$9.87

$1.97

0183T

Carrier Priced

Carrier Priced

• A patient having an open wound;minimal erythema • Severe psoriasis, limiting range of motion Limitations: Most Medicare contractors do not cover this modality for pressure ulcers.

Utilization Guidelines: Only 1 unit is covered per date of service, per discipline.

Documentation Guidelines: • Rationale for use of modality • Area(s) being treated • Objective clinical findings/measurements to support the need for ultraviolet • Minimal erythema dosage • Response of patient to treatment.

97032 Electrical Stimulation (manual) (to one or more areas),each 15 minutes Most Medicare contractors address this technology in their LCDs. 97032 is a constant attendance electrical stimulation (ES) modality that requires direct (one-on-one) manual patient contact by a qualified professional/ auxiliary personnel.

Because the use of a constant, directcontact ES modality is less frequent, documentation should clearly describe the type of ES provided as well as the medical necessity of the constant contact to justify billing 97032 versus G0283 (only used if ES unit is placed on the patient by the provider and does not require the continued presence and direct,one-on-one contact by the provider once setup is completed). Devices delivering high-voltage stimulation may require one-on-one patient contact.

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ES that may require constant attendance and should be billed as 97032 when continuous presence by the qualified professional/ auxiliary personnel is required includes: • Direct motor point stimulation delivered via a probe • Instructing a patient in the use of a home transcutaneous electrical nerve stimulation (TENS) unit. Once a trial of TENS has been done in the clinic over 1-2 visits and the patient has had a favorable response, the patient can usually be taught to use a TENS unit for pain control in 1-2 visits. Consequently,it is inappropriate for a patient to continue treatment for pain with a TENS unit in the clinic setting.

Indications: • Documented dependent peripheral edema with an accompanying reduction in the ability to contract muscles • Documented reduction in the ability to contract muscles or in the strength of the muscle contraction • Documented condition that requires an educational program for self-stimulation of denervated muscles • Documented condition that requires muscle re-education involving a training program (ie, functional ES) • Treatment of disuse atrophy using a specific type of neuromuscular electrical stimulator.

Limitations: • Treatment of facial nerve paralysis, commonly known as Bell’s palsy • Treatment of motor function disorders such as multiple sclerosis • Treatment of strokes when it is de-

May 2012 Today’s Wound Clinic®

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termined there is no potential for restoration of function • When ES is the only intervention utilized for strengthening of a muscle with at least “fair-graded” strength.

Most muscle strengthening is more efficiently accomplished through a treatment program that includes active procedures such as therapeutic exercises and therapeutic activities.

Utilization Guidelines: • No more than 4 units per code, per day, per discipline • If no objective and/or subjective improvement in swelling and/or pain are noted after 6 visits, a change in treatment plan (alternative strategies) should be implemented or documentation should support need for continued use of this modality.

• For swelling and pain control, the efficacy of this modality should be met in 10-12 visits, at most.

Documentation Guidelines: • Type of ES used (Do not limit the description to “manual” or “attended.”)

• Area(s) being treated • If used for muscle weakness, objective rating of strength and functional deficits • If used for pain, include pain rating, location of pain, effect of pain on function • Must support the need for continued treatment for > 12 visits.

G0281 ES (unattended), to one or more areas, for chronic stage III and stage IV pressure ulcers, arterial ulcers, diabetic ulcers,and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care A Medicare NCD covers this technology.

Indications: • Chronic stage III and stage IV pressure ulcers • Arterial ulcers • Diabetic ulcers • Venous stasis ulcer.

Limitations: • Stage I or stage II wounds • As an initial treatment modality • Measurable signs of healing have not

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businessbriefs Table 2. Coding, Medicare Payment, and Patient Coinsurance for TENS Use at Home

HCPCS Code

Description

2012 National Average Medicare Payment Rate

2012 National Average Patient Coinsurance

E0720

Transcutaneous electrical nerve stimulation (TENS) device, 2 lead, localized stimulation

$394.82

$78.96

E0730

TENS device, 4 or more leads, for multiple nerve stimulation

$398.03

$79.61

E0731

Form-fitting conductive garment for delivery of TENS or neuromuscular electrical stimulation (with conductive fibers separated from the patient’s skin by layers of fabric)

$383.13

$76.63

A4557

Lead wires

$22.67

$4.53

A4557

Lead wires

$22.67

$4.53

been demonstrated within a 30-day period of treatment • Wounds that demonstrate a 100 percent epithelialized wound bed • Treatment used in an unsupervised setting, as this has not been found to be medically reasonable and necessary.

Utilization Guidelines: • When covered ulcers do not demonstrate measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care • Only 1 unit is covered per date of service, per discipline.

• Wounds must be evaluated periodically (no less than every 30 days) by the treating physician.

Documentation Guidelines: • Etiology and duration of wound • Type of prior treatments by a physician, non-physician, nurse, and/or therapist that failed, including the duration of the failed treatment • Stage of wound • Description of wound: length, width, depth, grid drawing, and/or photos • Amount, frequency, color, odor, type of exudate • Evidence of infection, undermining, or tunneling • Nutritional status • Comorbidities (eg, diabetes mellitus, peripheral vascular disease) • Pressure support surfaces in use • Patient’s functional level • Skilled plan of treatment, including specific frequency of the modality

•C hanging plan of treatment based on clinical judgment of the patent’s response or lack of response to treatment •F requent skilled observation and assessment of wound healing (at least weekly, but preferably with each treatment session).

G0329 Electromagnetic therapy, to one or more areas for chronic stage III and stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care as part of a therapy plan of care A Medicare NCD covers this therapy.

Indications: •C hronic stage III and stage IV pressure ulcers • Arterial ulcers • Diabetic ulcers • Venous stasis ulcers.

Limitations: • Stage I or stage II wounds •E S when used as an initial treatment modality •C ontinued treatment if measurable signs of healing have not been demonstrated within any 30-day period of treatment • Wounds that demonstrate a 100 percent epithelialized wound bed • A patient in the home setting, as unsupervised use by patients in the home has not been found to be medically reasonable and necessary.

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Utilization Guidelines: • When covered ulcers do not demonstrate measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care • Only 1 unit is covered per date of service, per discipline.

• Wounds must be evaluated periodically (no less than every 30 days) by the treating physician.

Documentation Guidelines: • Etiology and duration of wound • Type of prior treatments by a physician, non-physician, nurse, and/or therapist that failed, including the duration of the failed treatment • Stage of wound •D escription of wound: length, width, depth,grid drawing,and/or photographs • Amount, frequency, color, odor, type of exudate •E vidence of infection, undermining, or tunneling • Nutritional status •C omorbidities (eg, diabetes mellitus, peripheral vascular disease) • Pressure support surfaces in use • Patient’s functional level • S killed plan of treatment, including specific frequency of the modality •C hanging plan of treatment based on clinical judgment of the patent’s response or lack of response to treatment • Frequent skilled observation and assessment of wound healing (at least weekly, but preferably with each treatment session).

Today’s Wound Clinic® May 2012

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5/4/12 4:40 PM

businessbriefs 97035 Ultrasound (to one or more areas) Most Medicare contractors address this technology in their LCDs. Indications: • Limited joint motion that requires an increase in extensibility • Symptomatic soft-tissue calcification • Neuromas.

Limitations: • Asthma, bronchitis, or any other pulmonary condition • Conditions for which the ultrasound can be applied by the patient without the need for a therapist or other professional to administer, and/or for extended period of time • Wounds.

Utilization Guidelines: • No more than 2 units per code, per day, per discipline • Non-thermal ultrasound for wound healing may be indicated for nonnecrotic wound(s) only after documented standard wound care has been used for a minimum of 30 days with no measurable signs of healing.

• If no objective and/or subjective improvements are noted after 6 treatments, change in treatment plan (alternative strategies) should be implemented or documentation should support the need for continued use of this modality.

Documentation Guidelines: • Rationale for use of modality • Area(s) being treated • Frequency and intensity of ultrasound and time applied • Response of patient to treatment • Objective clinical findings, such as measurements of strength, range of motion, and functional deficits/limitations to support need for ultrasound • S ubjective findings to include pain ratings, pain location, effect on function • Functional progress at reassessment and/or discharge. If there’s no progress, a reason and/or alternative treatment strategy should be documented.

• Must support the need for continued treatment with this modality for > 12 visits.

NOTE: Some Medicare contractors do not cover this modality for wound care.

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BIOPHYSICAL TECHNOLOGIES AT HOME

Utilization Guidelines: • Pain must have been present for at least 3 months. Other appropriate treatment modalities must have been tried and failed. The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy.

• When used for the treatment of chronic, intractable pain, the TENS unit must be used by the patient on a trial basis for a minimum of 1 month (30 days), but not to exceed 2 months.

The trial period will be paid as a rental.

The trial period must be monitored by the physician to determine the effectiveness of the TENS unit in modulating the pain. The physician’s records must document a re-evaluation of the patient at the end of the trial period, must indicate how often the patient used the TENS unit, the typical duration of use each time, and the results.

• For coverage of a purchase, the physician must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time.

• The physician ordering the TENS unit must be the attending or consulting physician for the disease or condition resulting in this need.

Documentation Guidelines: • Location of the pain • Duration of time patient had pain • Presumed etiology of the pain • Treatment modalities that have been tried and failed.

Although few patients with chronic wounds would meet coverage criteria for use of a TENS unit at home, Table 2 shows HCPCS codes that durable medical equipment suppliers must use when they supply TENS units for patient use at home.Table 2 also shows the 2012 national average Medicare payment rate and the patient’s coinsurance responsibilities. n

TENS A Medicare NCD provides coverage guidelines for TENS. Indications: • Chronic, intractable pain • Acute post-operative pain.

Kathleen D. Schaum, MS, is president and founder of Kathleen D. Schaum & Associates, Inc., Lake Worth, FL. She can be reached by emailing: kathleendschaum@bellsouth.net or calling 561-964-2470.

0183T Low-frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care,per day Some Medicare contractors address this technology in their LCDs. Some cover it per the guidelines below. Others do not separately cover this technology and state that it is included in the payment for evaluation and management or other concurrent wound care services.

Indications: • Nonhealing wounds of > 1 month of conservative care with documented TCO2 of > 20, with evidence of inflammation, infection, or significant yellow slough, fibrin, or tissue exudates • Wounds, burns, and ulcers meeting Medicare coverage for debridement that are too painful for sharp or excisional debridement • Wounds, burns, and ulcers meeting Medicare coverage for debridement,but with documented contraindications to sharp or excisional debridement • Wounds, burns, and ulcers meeting Medicare coverage for debridement but with documented evidence of no signs of improvement after 30 days of standard wound care.

Utilization Guidelines: • No more than 3 times per week • Once epithelialized wound bed occurs, therapy should be discontinued • No ongoing use after 1 month unless specific conditions, such as improving wound measurement, drainage reduction, and increase in granulation tissue is noted.

Documentation Guidelines: • Reduction in pain, necrotic tissue, wound size • Improved and increased granulation tissue

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MIST Therapy penetrates into and below the wound bed ®

Accelerates Healing By: • Removing Barriers * Bacteria1

* Biofilm2

* Inflammation3

* MMP-93

• Stimulating Cells * Vasodilatation4 * Angiogenesis5 * Growth Factors6

* Collagen Deposition5

Most wound care therapies are limited to treating the wound surface.

MIST Therapy’s sound waves penetrate into and below the wound bed to accelerate healing by removing barriers and stimulating cells.

To learn more, call 866-307-MIST or visit www.misttherapy.com 1.

Serena T, et al. OWM 2009;55(1):22-30.

3.

Fabbi M et. Al. DLS 2011.

5.

Thawer HA, Houghton PE. J Wound Care. 2004;13(5):1–6.

2.

Akhil S, et al. SAWC 2012.

4.

Liedl DA, Kavros SJ. SAWC 2001.

6.

Lai JY, Pittelkow MR. Int J Dermatol. 2007;46(6):587-593.

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5/4/12 2:04 PM

Decreasing Pain & Improving Quality of Life:

Clinical Strategies for Chronic Wound Patients Kevin Y. Woo, PhD, RN, FAPWCA

P

ain is a common experience among those living with chronic wounds.

Pain impacts all aspects of everyday life, including physical activity, sleep, and social functioning. In the process, pain can erode one’s quality of life.2-4 Some patients continue to provide vivid descriptions of their painful experiences long after their ulcers are healed.5 While wound-associated pain often is caused by intrinsic wound pathology and exacerbated by local manipulation that is part of routine wound management, the intensity of pain is subjected to influences of many personal and social factors.The complexity of pain necessitates a systematized approach to obtain a thorough pain history, evaluate aggravating and alleviating factors, assess the wound and surrounding tissue, and monitor outcomes. Optimal pain management must be incorporated as an integral part of comprehensive wound care in order to improve quality of life. It is imperative to approach wound-associated pain by first identifying the triggers (related to wound pathologies or procedures) and

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by evaluating the number of neurobiopsychosocial factors that may affect the pain experience. A variety of approaches drawing on expertise from interprofessional teams is crucial to optimize pain management. Studies of patients living with various chronic wound types validate the pervasiveness of pain. Szor and Bourguignon6 reported in a study that as many as 88% of people with pressure ulcers express pressure ulcer pain at dressing change and that 84% experienced pain even while at rest. Of those with venous leg ulcers, the majority experienced moderate to severe levels of pain described as aching, stabbing, sharp, tender, and tiring.7 Pain has been documented to persist up to at least 3 months after wound closure.7,8 Contrary to the commonly held belief that most patients with diabetic foot ulcers do not experience pain due to loss of protective sensation, up to 50% of patients experience varying degrees of predominantly neuropathic painful symptoms, according to researchers.9

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Consequences of Wound Pain

To avoid pain, many patients feel forced to limit their activities of daily living (eg, bathing), social interaction, time with family, and work. Patients often describe wound-associated pain as all-encompassing and one of the most devastating aspects of living with chronic wounds.4 Upton et al1 have documented that pain is a significant predictor of acute and chronic stress in chronic wound patients. As part of the cascade of stress response, the overproduction of cortisol and catecholamines can have a significant impact, delaying wound healing due to alteration in the immune system.10 Woo and Sibbald11 followed 111 home care clients with either leg or foot ulcers prospectively for 4 weeks to determine the effectiveness of comprehensive wound assessment and management.

Wound-related pain was addressed by education, careful selection of wound dressings, application of topical analgesics

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managingpain

during dressing changes, and use of systemic analgesics. The average pain-intensity score was reduced from 6.3 at baseline to 2.8 at week 4 (P < .001). To examine the relationship between pain and wound healing, pain-intensity scores were compared among those who achieved wound closure by the end of data collection to those who did not. The mean pain intensity score was 1.67 for subjects who achieved wound closure as compared to an average score of 3.21 among those who did not achieve complete wound closure (P < .041). The result lends credence to the importance of pain management to promote wound healing.

Wound-Related Mechanisms

Pain can be present due to a number of factors.

Wound-related triggers. Underlying wound-related pathologies resulting in ischemic damages, prolonged inflammation, and nerve injuries are often the reason for background persistent pain. The presence of unexpected pain/tenderness along with other criteria is also indicative of infection in chronic wounds.17,18 Following re-

peated insult, excessive and prolonged inflammation can lead to spontaneous “wind-up” pain or exaggerated or prolonged painful responses to normally painful stimuli (hyperalgesia) and even non-painful stimuli (allodynia).20 Procedure-related triggers. Despite obvious therapeutic values and primary intentions to optimize wound healing, many wound-management procedures are painful. Most obvious, debridement using a sharp surgical instrument can cause a considerable amount of pain.23 Trauma at dressing removal has been documented to cause pain in several observational studies.4 Dressing materials often adhere to the fragile wound surface due to the gluelike nature of dehydrated or crusted exudate. Potential local trauma may evoke pain each time the dressing is removed. In addition, the granulation tissue and capillary loops may grow into the product matrix — especially gauze dressings and with the use of negative pressure wound therapies — potentiating the likelihood of trauma and bleeding with dressing removal. According to a review of dressings and topical agents

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for secondary intention healing of postsurgical wounds, patients experienced significantly more pain with gauze than with other types of dressings.24 Wound care providers practicing evidencebased care should avoid the use of gauze products in painful wounds. To ensure dressing securement, strong dressing adhesives or tapes are often used. However, repeated application and removal of adhesive tapes and dressings strip the stratum corneum from the skin epithelial cell surface, damaging the skin. In severe cases, contact irritant dermatitis results in local erythema, edema, and blistering of the wound margins.25 Wound cleansing is part of routine wound care that is likely to cause pain during dressing changes.26 The routine practice of using abrasive materials and gauze to scrub the wound surface should be discouraged. Clinicians must understand that pain can be caused by pressure-relieving equipment and treatment-related activities, such as repositioning, especially among patients who have significant contractures, increased muscle spasticity, and spasms. Some patients consider compression therapy

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managingpain Table 1. Patient-Oriented/Multifaceted Approach to Pain Management Strategy

Objectives

Pharmacological

• Topical: o Topical ibuprofen (dressing not available in the US) o Morphine o Topical lidocaine • Systemic: oN ociceptive pain: Acetylsalicylic acid, NSAIDs, acetaminophen for mild to moderate pain o Opioids for moderate to intense pain o Neuropathic pain: SNRIs, anticonvulsants

Local Wound Care

• Atraumatic dressing to prevent painful removal • Moisture-interactive dressing to avoid wound desiccation • Anti-inflammatory dressing materials (eg, collagen/oxidized regenerated cellulose) • Barrier to protect periwound skin • Topical or systemic antimicrobial dressings/agents for infections

Physical Therapies

• Hot/cold compress • Massage • Exercise • Electrical stimulation • Topical or hyperbaric oxygen therapy

Education

• Web-based learning • Face-to-face education: o Explain mechanism of pain o Dispel misconceptions about pain o Address concerns about addiction o Emphasize the availability of multiple strategies

Anxiety Reduction

• Relaxation • Distractions • Music therapy

Cognitive Therapy

• Cognitive behavior therapy • Problem-solving skills • Positive thinking

Therapeutic Alliance

• Communication techniques (eg, reflective listening) • Goal-setting • Align expectations • Demonstrate sympathy

Empowerment

• Allow individual to call “timeout” • Respect individual’s choices • Maximize autonomy: active participation • Functional focused therapy

• Imagery • Education • Support groups

© Woo 2011

treatment of venous stasis to be uncomfortable. Briggs and Closs27 indicate that only 56% of patients in their study were able to tolerate full compression bandaging, with pain being the most common reason for non-adherence.

Wound-Associated Pain

Pain is a complex biopsychosocial phenomenon. Melzack28 introduced the term “neuromatrix” to connote the intricate interactions among a number of modulating factors. Despite seemingly comparable levels of pain intensity, persons with pain experience varying degrees of physical limitations, emotional distress, and suffering. The in-

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tegrated wound-associated pain model in Figure 1 posits the multi-dimensionality of pain in response to wound- and procedurerelated triggers. Understanding that emotions, cognitive process, social environment, and attitudes can influence how people feel, the various separate dimensions are created merely for heuristic purpose.

For instance, nocebo effect or negative placebo effect delineates pain amplification by expectation of pain and heightened anxiety. 29, 30 The result is a vicious cycle of pain, stress/anxiety, and worsening of pain.

In a study of 96 patients with chronic wounds, Woo26 reported those who experienced high levels of anxiety also reported

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high levels of anticipatory pain, leading to high levels of pain at dressing change. Certain personalities may be more vulnerable to noxious stimuli in light of their propensity to experience anxiety and catastrophize their experience. Comprehensive wound pain management should incorporate an assessment of the person’s anxiety level, stress, expectation, and social environment.

Properly Assessing Pain

Pain assessments should be well documented to facilitate the continuity of patient care and to benchmark the effectiveness of management strategies.

Many methods of pain assessment have been developed, ranging from subjective self-reports to objective behavioral checklists. Remember that pain is a subjective experience. An individual’s self-report of pain is the most reliable method to evaluate pain.

Other assessment methodologies include physiological indicators, behavioral manifestations, functional assessments, and diagnostic tests. Categorical scales, numerical rating scales, pain thermometers, visual analogue scales, face scales, and verbal categorical scales are one-dimensional tools commonly used to quantify pain in terms of intensity, quality (characteristics), pain unpleasantness, and pain relief.31 To obtain a comprehensive assessment of pain, multidimensional measurements are available to evaluate the many facets of pain and its impact on daily functioning, mood, social functioning, and other aspects of quality of life.

The key questions to ask about pain can be remembered through the mnemonic PQRSTU.32,33 See below: • P — Provoking/Palliating Factors: What makes your pain worse?

What makes your pain better (eg, warm weather, walking, certain types of cleansing solutions or dressings)?

• Q — Quality of Pain: What does your pain feel like? Descriptors (eg, burning, electrical shocks, pricking, tingling pins) may help differentiate the two types of pain: nociceptive and neuropathic.

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managingpain Table 2. Analgesics: Mode of Action, Dosage, & Side Effects Medication

Mode of Action

Dosage

Side Effects

Acetaminophen

Affects nitric oxide cycle, antipyretic property

325–650 mg q 4 h up to a maximum of 4 g/d in healthy people

Do not exceed 4 g/d to avoid liver toxicity

Acetylsalicylic acid (ASA)

Inhibits the enzyme cyclooxygenase (COX)

325–650 mg q 4–6 h up to 4 g/d

Gastritis, gastrointestinal bleeding, acute renal failure, may interact with anticoagulants

Inhibit COX

Common NSAIDs: • Ibuprofen 200–400 mg q 4–6 h • Ketoprofen 25–50 mg q 6–8 h • Naproxen 250 mg q 6 h Common COX-2 NSAIDs: • Celecoxib 200–400 mg od • Rofecoxib 25–50 mg od • Meloxicam 7.5–15 mg od

Similar as ASA, fewer side effects with COX-2 NSAIDs

Non-Opioid

NSAIDs and COX-2 selective NSAIDs

Co-Analgesic (Adjuvant) Tricyclic antidepressant (TCA)

Inhibit serotonin and NE reuptake; block sodium channels

Common TCAs: Amitriptyline, doxepin, nortriptyline 10–25 mg q hs, titrate up to 150–200 mg/d

Dry mouth, drowsiness, orthostatic hypotension

Anticonvulsants

Most agents block sodium channels; unknown for gabapentin

Common anticonvulsants: Carbamazepine 100 mg od to maximum dose 1200 mg/d, gabapentin 100 mg TID titrate up to 3000 mg/d

Drowsiness, dizziness, fatigue

Morphine

Gold standard mu agonist

For patients who are opioid naive, start on morphine 2.5–10 mg po q 4 h with 10% of total daily dose (TDD) q 1 h as needed

Codeine

Weak mu agonist; 0.125 as potent as morphine; convert to active analgesic by enzyme CYP2D6

Codeine 100 mg = morphine 10 mg (~10:1)

Oxycodone (may be combined with ASA or acetaminophen)

Mu and kappa agonist; 2x as potent as morphine

Oxycodone 5 mg or Percocet 1 tab (5/325) = morphine 10 mg (1:2)

Hydromorphone

5–7.5x as potent as morphine

Hydromorphone 2 mg = morphine 10 mg (1:5)

Methadone

Mu and delta agonist; blocks NMDA; 10x more potent than morphine

Variable

Opioids (CR/SR)

Key: h=hour; d=day; q=every; od=daily; hs=evening; TID=three times per day; NSAID=nonsteroidal anti-inflammatory drug; NE=norepinephrine; po=by mouth

•R — Regions and Radiation: Where is the pain, and does the pain move anywhere (eg, in and around the wound, the wound region, unrelated)?

• S — Severity or Intensity: How much does it hurt on a scale of 0–10, with 0 representing “no pain” and 10 representing “pain as bad as

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it could possibly be”?

• T — Timing or History: When did the pain start? Is it present all the time? (A pain diary may help to map out the temporal pattern of pain, ie, the pain worsens at night.)

• U — Understanding: What is important to you for pain relief? How would you like to get better?

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Constipation, delirium, sedation, nausea, vomiting, urinary retention

© Woo 2011

As an alternative, studies have shown the observation of nonverbal indicators encompassing a wide range of vocalized signals and bodily movements may provide a means of assessing pain in patients (eg, neonates or cognitively impaired) who are not able to verbalize pain. Several tools are available, including: • Abbey Pain Scale Assessment of Dis-

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managingpain comfort in Dementia Protocol Checklist of Nonverbal Pain Indicators; • Discomfort Scale-Dementia of the Alzheimer’s Type; • Face, Legs, Activity, Cry, and Consolability Pain Assessment Tool; • Pain Assessment in Advanced Dementia Scale; and • Pain Assessment Scale for Seniors with Severe Dementia.

Despite the robust psychometric properties of these measurement tools, it is important to remember behaviors (eg, facial expression, body movements, crying) that signal pain may vary significantly among individuals, and there is no evidence that any single behavior or number of behaviors is more reliable to measure the presence or intensity of pain.31,34 Pain measurement tools may include word descriptors to qualify pain and allow clinicians to differentiate neuropathic from nociceptive pain. Nociceptive pain incurred by tissue damage stimulates pain receptors in the muscle, bone, joints, and ligaments (somatic pain) or in the viscera and peritoneum (visceral pain). Nociceptive pain is often described as sharp, dull, aching, throbbing, or gnawing. In contrast, neuropathic pain is caused by injury and sensitization of the peripheral or central nervous system. Neuropathic pain is mostly described as burning, electrical shocks, pricking, tingling pins, and increased sensitivity to touch. Specific assessment protocols are developed to evaluate neuropathic pain.35 In all, no single tool has been deemed universal and useful for all patients. The selection of a specific pain scale must take into account the patient’s age, language, educational level, sensory impairment, developmental stage, and cognitive status. Once chosen, the same measurement scale should be used for subsequent assessments for ongoing comparison. Changes in pain levels may indicate a need to reassess the choice and timing of analgesics and/or other interventions used in pain management.

Managing Wound Pain

A patient-oriented and multifaceted approach (see Table 1) is recommended for the management of wound-associ-

ated pain with the objectives to address pain relief, increase function, and restore overall quality of life. Pharmacotherapy continues to be the mainstay for pain management. Appropriate agents are selected based on severity and specific types of pain.The World Health Organization’s analgesic ladder36 proposes that treatment of mild (1-4 out of 10) to moderate (5-6 out of 10) nociceptive pain should begin with a non-opioid medication, such as acetaminophen and nonsteroidal antiinflammatory drugs.

For controlling more severe (7-10 out of 10) and refractory pain, opioid analgesics should be considered. Management of neuropathic pain or associated symptoms (eg, anxiety and depression) may include the possibility of adding adjuvant treatments. Three classes of medications are recommended as first-line treatments for neuropathic pain: antidepressants with both norepinephrine and serotonin reuptake inhibition (tricyclic antidepressants and selective serotonin and norepinephrine reuptake inhibitors), calcium channel α2δ ligands (gabapentin and pregabalin), and topical lidocaine (lidocaine patch 5%).20 In addition to the severity and pain types, selection of appropriate pharmaceuticals should always take into account the characteristics of the drug (onset, duration, available routes of administration, dosing intervals, side effects; see Table 2) and individual factors (age, coexisting diseases, and other over-the-counter or herbal medications).20

How to Use Analgesics

As a general rule, analgesics should be taken at regular intervals until pain is adequately relieved. Whenever possible, the oral route of medication administration is preferred. After a titration period with short-acting preparations (it takes five half-lives of an analgesic agent to reach a steady state) to estimate the required dosing for managing continuous stable pain, controlled-release medications should be considered to facilitate around-the-clock dosing, especially at night. Nonetheless, short-acting medications should be made available for occasional breakthrough pain. In some

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cases, it may be necessary to consider the use of two or more drugs from different classes. Their complementary mechanisms of action may provide greater pain relief with less toxicity and lower doses of each drug. For the elderly population, it’s advisable to “start low and go slow”37 in order to circumvent untoward adverse effects. (See common side effects of analgesics in Table 2.) Common side effects, such as constipation, nausea, confusion, and drowsiness, should be monitored and managed appropriately. However, if the pain is (anticipated to be) severe, conscious sedation, combining sedatives and potent narcotic analgesics, such as sublingual fentanyl or sufentanil (approximately 100 times more potent than morphine) and ketamine, can be used with success.20 In resistant cases, options may include general anesthesia, local neural blockade, spinal analgesia, or the use of mixed nitrous oxide and oxygen.

Topical agents play a critical role in alleviating wound-related pain. Slowrelease ibuprofen foam dressings (available in Canada and Europe) have demonstrated reduction in persistent wound pain between dressing changes and temporary pain on dressing removal.38 The topical use of NSAIDs, capsaicin, and lidocaine/prilocaine has demonstrated effectiveness for pain relief.3,12 However, the lack of pharmacokinetic data precludes the routine clinical use of these compounds at this time.

There are many advantages to using local rather than systemic treatment.

Any active agent is delivered directly to the affected area, bypassing the systemic circulation, and the dose needed for pain reduction is lower, minimizing the risk of side effects.

Reducing Procedural Pain

In addition to pharmacotherapy, careful selection of dressings with atraumatic and non-adherent interfaces, such as silicone, has been documented to limit skin damage/trauma with dressing removal and to minimize pain at dressing changes.40 Silicone coatings do not adhere to moist wound beds and have a

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managingpain low surface tension due to their unique structure, which consists of chains of hydrophobic polymers with alternate molecules of silicone and oxygen.

Numerous sealants, barriers, and protectants, such as wipes, sprays, gels, and liquid roll-ons, are designed to protect the periwound skin from trauma induced by adhesives.41 Wound cleansing should involve less-abrasive techniques, such as compressing and irrigating with normal saline or water. Topical antimicrobial dressings and related products should be considered when surface compartment critical colonization is indicated by increased pain.

Education is a key strategy to empower patients and individuals within their circle of care, and to improve wound-related pain control. Patients and individuals within their circle of care should be informed of various treatment options and be empowered to be active participants in care. Being an active participant involves taking part in the decision-making for the most appropriate treatment, monitoring response to treatment, and communicating concerns to healthcare providers.

Common misconceptions about pain management should be addressed.3 Fear of addiction and adverse effects has prevented patients from taking regular analgesics. In one pilot study,42 chronic wound patients described dressingchange pain as being more manageable after receiving educational information.

Pain-related education is a necessary step to effect change in pain management by debunking common misconceptions and myths that may obstruct effective pain management. Cognitive therapy that aims at altering anxiety by modifying attitudes, beliefs, and expectations by exploring the meaning and interpretation of pain concerns has been successful in the management of pain.26 This may involve distraction techniques, imagery, relaxation, or altering the significance of the pain to an individual. Patients can learn to envision pain as less threatening and unpleasant through positive imagery by imagining pain disappearing or by conjuring a mental picture of a place that evokes feelings and memories of

18

comfort, safety, and relaxation. In addition to pain, clinicians should pay attention to other sources of anxiety that may be associated with stalled wound healing, fear of amputation, body disfigurement, repulsive odor, social isolation, debility, and disruption of daily activities.3 Relaxation exercises can reduce anxietyrelated muscle tension adding to pain. n Kevin Woo is assistant professor in the Queen’s University School of Nursing; wound care consultant for West Park Health Centre, Toronto. He may be reached at kevin.woo@queensu.ca.

REFERENCES

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2. Krasner D. Carrying on despite the pain: living with painful venous ulcers. a Heideggerian hermeneutic analysis [dissertation].

Ann Arbor, MI: UMI; 1997.

3. Woo KY. Meeting the challenges of wound-associated pain: anticipatory pain, anxiety, stress, and wound healing. Ostomy Wound Manage. 2008;54(9):10–12.

4. Woo K, Sibbald G, Fogh K, et al. Assessment and management of persistent (chronic) and total wound pain. Int Wound J. 2008;5(2):205–215.

5. Flaherty E.The views of patients living with healed venous leg ulcers. Nurs Stand. 2005;19(45):78,80,82–83.

6. Szor JK, Bourguignon C. Description of pressure ulcer pain at rest and at dressing change. J Wound Ostomy Continence Nurs.

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7. Nemeth KA, Harrison MB, Graham ID, Burke S. Understanding venous leg ulcer pain: results of a longitudinal study. Ostomy Wound Manage. 2004;50(1):34–36.

8. Pieper B, Szczepaniak K, Templin T. Psychosocial adjustment, coping, and quality of life in persons with venous ulcers and a history of intravenous drug use. J Wound Ostomy Continence Nurs. 2000;27(4):227–237.

9. Evans AR, Pinzur MS. Health-related quality of life of patients with diabetes and foot ulcers. Foot Ankle Int. 2005;26(1):32–37.

10. Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress.

Lancet. 1995;346(8984):1194–1196.

11. Woo KY, Sibbald RG. The improvement of wound-associated pain and healing trajectory with a comprehensive foot and leg ulcer care model. J Wound Ostomy Continence Nurs.

2009;36(2):184–191.

12. Krasner D.The chronic wound pain experience: a conceptual model. Ostomy WoundManage. 1995;41(3):20–25.

13. Woo KY, Sibbald RG. Chronic wound pain: a conceptual model. Adv Skin Wound Care. 2008;21(4):175–190.

14. Bruce AJ, Bennett DD, Lohse CM, Rooke TW, Davis MD. Lipodermatosclerosis: review of cases evaluated at Mayo Clinic. J Am Acad Dermatol. 2002;46(2):187–192.

15. Aquino R, Johnnides C, Makaroun M, et al. Natural history of claudication: long-term serial follow-up study of 1244 claudicants. J Vasc Surg. 2001;34(6):962–970.

16. Grey JE, Harding KG, Enoch S.Venous and arterial leg ulcers.

BMJ. 2006;332(7537):347–350.

17. Cutting KF, White RJ. Criteria for identifying wound infection--revisited. Ostomy Wound Manage. 2005;51(1):28–34.

18. Moore Z, Cowman S. Effective wound management: identifying criteria for infection. Nurs Stand. 2007;21(24):68,70,72.

19. Gardner SE, Frantz RA, Doebbeling BN. The validity of the clinical signs and symptoms used to identify localized chronic

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wound infection. Wound Repair Regen. 2001;9(3):178–186.

20. Jovey RD, ed. Managing Pain: The Canadian Healthcare Professional’s Reference.Toronto, Ontario, Canada: Healthcare & Financial Publishing, Rogers Media; 2002.

21. Ji RR, Woolf CJ. Neuronal plasticity and signal transduction in nociceptive neurons: implications for the initiation and maintenance of pathological pain. Neurobiol Dis. 2001;8(1):1–10.

22. Woo KY, Coutts PM, Price P, Harding K, Sibbald RG. A randomized crossover investigation of pain at dressing change comparing 2 foam dressings. Adv Skin Wound Care.

2009;22(7):304–310.

23. Sibbald RG, Goodman L, Woo KY, et al. Special considerations in wound bed preparation 2011: an update©. Adv Skin Wound Care. 2011;24(9):415–436.

24.

Ubbink DT, Vermeulen H, Goossens A, Kelner RB, Schreuder SM, Lubbers MJ. Occlusive vs gauze dressings for local wound care in surgical patients: a randomized clinical trial. Arch Surg. 2008;143(10):950–955.

25. Thomas S. Atraumatic Dressings. Available at: www.worldwidewounds.com/2003/january/Thomas/AtraumaticDressings.html. Accessed February 7, 2008.

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27. Briggs M, Closs SJ. Patients’ perceptions of the impact of treatments and products on their experience of leg ulcer pain. J Wound Care. 2006;15(8):333–337.

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29. Colloca L, Benedetti F. Nocebo hyperalgesia: how anxiety is turned into pain. Curr Opin Anaesthesiol. 2007;20(5):435–439.

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31. http://www.iasp-pain.org 32. RNAO. Assessment of pain: questions to consider during assessment of pain (PQRST). Available at: http://pda.rnao. ca/content/assessment-pain-questions-consider-duringassessment-pain-pqrst. Accessed December 28, 2011.

33. Herr K, Coyne PJ, McCaffery M, Manworren R, Merkel S. Pain assessment in the patient unable to self-report: position statement with clinical practice recommendations. Pain Manag Nurs. 2011;12(4):230–250.

34. City of Hope Pain & Palliative Care Resource Center. Pain and symptom management. Available at: http://prc.coh.org/ pain_assessment.asp. Accessed December 28, 2011.

35. Arnstein P. Assessment of Nociceptive Versus Neuropathic Pain in Older Adults. Available at: http://consultgerirn.org/ uploads/File/trythis/try_this_sp1.pdf. Accessed December 28, 2011.

36. World Health Organization.WHO’s Pain Ladder. Available at: http://www.who.int/cancer/palliative/painladder/en/. Accessed December 28, 2011.

37. The AGS Foundation for Health in Aging. Medications for Persistent Pain. An Older Adult’s Guide to Safe Use of Pain Medications. Available at: http://www.healthinaging.org/ public_education/pain/know_your_pain_medications.pdf.

Accessed December 28, 2011.

38. Romanelli M, Dini V, Polignano R, Bonadeo P, Maggio G. Ibuprofen slow-release foam dressing reduces wound pain in painful exuding wounds: preliminary findings from an international real-life study. J Dermatolog Treat. 2009;20(1):19–26.

Briggs M, Nelson EA. Topical agents or dressings for 39. pain in venous leg ulcers. Cochrane Database Syst Rev. 2010;(4):CD001177.

40. Woo KY, Harding K, Price P, Sibbald G. Minimising woundrelated pain at dressing change: evidence-informed practice.

Int Wound J. 2008;5(2):144–157.

41. Woo KY, Sibbald RG. The ABCs of skin care for wound care clinicians: dermatitis and eczema. Adv Skin Wound Care.

2009;22(5):230–238.

42. Gibson MC, Keast D, Woodbury MG, et al. Educational intervention in the management of acute procedure-related wound pain: a pilot study. J Wound Care. 2004;13(5):187–190.

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Wound Bioburden: providing infection control While Managing Pain Dot Weir, RN, CWON, CWS; and Pamela G. Unger, BS, PT, CWS

T

he battle against bacteria is one fought daily in the delivery of wound care, and the outpatient wound clinic is certainly no exception. In fact, this setting may even be of more concern due to the nature of caring for multiple patients in the same treatment rooms in a single day.The practice of paying exquisite detail to infection control is one where we must never let our guard down as clinicians.We need to be so habitual in such methods of safety as glove use and hand hygiene that they should occur without conscious thought. Chronic wounds being what they are, the mere presence of bacteria on the surface of an open wound is expected and frequently not an impediment for the eventual closure and ultimate healing of the wound.1 However, it is imperative that it be eliminated as much as possible, not just for sanitation and patient-safety concerns, but since proliferation of bacteria can lead to clinical infection and the complaint of pain is frequently an accompanying presenting factor.2 Therefore, an essential part of wound bed preparation is to control bacterial proliferation and to prevent colonization to the critical point of impacting wound healing. There

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are growing numbers of antimicrobial dressings available in all categories when bacterial proliferation is suspected or confirmed. Beyond dressings, there are measures and modalities that further enable us to continue the bacterial battle, including wound cleansing, ultrasoundassisted wound therapy (UAW), and ultraviolet energy (see sidebar on page 21). Some of these measures can also be implemented without causing further physical pain to the patient.

Focus On Hypochlorous Acid

Wounds should be cleansed before and after debridement as well as between dressing changes. The choice of solution to be used must be driven by the goal of care and the need to clean versus the need to disinfect. A clean, granulating wound may only require isotonic saline or other non-toxic solution or cleanser to remove residue from a previous treatment or dressing. In the presence of odor, abnormal color of exudate, or other signs of increasing colonization, use of an antimicrobial product to both cleanse and reduce surface bacterial burden will be beneficial.

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Recently, a cleansing-and-moistening solution known as hypochlorous acid (HOCI) has been made available for clinical practice and commercial use in the forms of single-patient bottles and sprays (eg, Vashe Wound Therapy,® PuriCore, Malvern, PA; Microcyn® Skin and Wound Cleanser, Oculus Innovative Sciences, Petaluma, CA; and NeutroPhase® Wound Cleanser, NovaBay Pharmaceuticals, Inc., San Francisco, CA). A naturally occurring small molecule generated by white blood cells in the human body, HOCI can also be produced by electrolysis using a generator and specific electrolyte fluid for point-of-use care in the clinic setting (eg, Vashe). The resulting HOCI solution is stable for 72 hours in an opaque container at room temperature and for 14 days when refrigerated.

An important attribute of the human body’s immune system is its ability to instigate a rapid attack against invading pathogens by releasing highly potent oxidized molecules such as HOCI. After engulfing invading pathogens, neutrophils releases an “oxidative burst” of HOCI that quickly destroys engulfed

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managingpain bacteria, viruses, or fungi. Produced by neutrophils, HOCI affects microbial cell permeability and kills microorganisms by binding to critical cell membrane components. This leads to the rupture of cell membranes and subsequent disintegration of microbial cells.

Indicated for use on diabetic ulcers, venous ulcers, stage I-IV pressure ulcers, and first- and second-degree burns, HOCI offers demonstrated efficacy in the treatment of chronic ulcers. In a pilot evaluation, Selkon et al observed ulcer pain was significantly reduced and 45% of ulcers healed in patients treated with HOCI.3 In vitro analysis of cell toxicity testing of keratinocytes and fibroblasts showed no negative effects.

The pH of HOCI is approximately 5.4, close to the natural protective pH of human skin.4 Clinically, HOCI has been found to reduce or eliminate odor on contact, soften dried exudate and callus, and break down surface debris and coagulum, making both easier to remove from the wound surface without trauma.

When considering the concept of pain in wound management, the impact of wound odor and exudate can have profound effects on quality of life.

Add to that the impact that a particularly malodorous wound/limb can have on the wound clinic and the potential reaction by staff and other patients, and the impact on the patient is that much more. Though not always mentioned and certainly not quantifiable, this impact on the patient’s life can unquestionably cause mental anguish or mental “pain.” Consequently, another clinical use of HOCI that one author’s clinic has found extremely effective is in its use as a soak on malodorous wounds, moist callus, legs, and fungating wounds for 10-15 minutes to dramatically reduce the odor.

Low-Frequency Ultrasound

Emerging technology using ultrasonic devices has shown impressive outcomes as an intervention for debridement and reducing bioburden in the wound bed. However, utilization of ultrasound is hardly a new concept to the healthcare industry. Use of ultrasound to treat

Ultraviolet Energy Wound Treatment Joe McCulloch, PhD, PT

Well before there was any understanding of the sun’s electromagnetic energy, early physicians such as Hippocrates (460-370 B.C.) and Galen (131-201 A.D.) prescribed sunlight as a treatment for a variety of ills.28 It has been in the last century, however, that the actions of the sun’s ultraviolet (UV) energy has been understood and artificial energy sources have been developed to harness the energy for specific therapeutic purposes.

Radiation from the sun is divided into three wavelength-specific groups. UVA radiation, with wavelengths between 320 and 400 nm, is primarily responsible for the production of mild erythema or tanning. UVB, with wavelengths between 290 and 320 nm, produces a more marked erythema or blistering. Generally, these two forms of UV have little utility in wound care, but may have benefits in the treatment of other dermatological conditions such as psoriasis.29 The third wavelength range (200-290 nm) corresponds to the UV energy known as UVC and has strong antibacterial properties. UV radiation at this frequency is generally absorbed in the ozone layer and, therefore, does not reach earth. Fortunately, the energy can be reproduced by therapeutic generators that provide great clinical benefit. Much evidence has been provided on the beneficial aspects of UVC in treating wound bioburden.30 Conner-Kerr et al observed a 99.9% kill rate when MRSA was exposed to five seconds of UVC radiation in vitro. A 100 % kill rate was seen when the exposure time increased to 45 seconds.31,32 Thai et al33 performed similar work in vivo, noting that with a single 180-second dose of UVC, MRSA could be eliminated from a lightly colonized wound. Penetration of UVC is superficial. For this reason, it should not be expected that use of this biophysical technology could completely clear a wound or infection. It instead has a role in reducing bioburden and aiding in wound bed preparation.

Anyone interested in using ultraviolet treatment should consult a physical therapist (PT) who has the technology. PTs are equipped to determine proper dosing and provide protection to other photosensitive tissues that could be harmed by inadvertent exposure to UV light.

medical disorders appeared in Germany in the late 1930s and in the US in the late 1940s.5 Therapeutic ultrasound delivers energy through mechanical vibrations in the form of sound waves at frequencies that are above the threshold of human hearing (>20 kHz). Historically, ultrasound is commonly associated with diagnostic imaging, which involves the use of high-frequency ultrasound waves with minimal physiological effects. In addition, high-frequency therapeutic ultrasound (in the range of 1-3 mHz) has been used in physical therapy, physical medicine, and rehabilitation and sports medicine for many years for the treatment of soft-tissue injuries and wounds.6 In recent years, low-frequency ultrasound has been employed to impact tissues in the chronic wound bed. Different frequencies (Hz) are used therapeutically to treat and assess soft tissues.

Despite ultrasound technology’s

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long-held presence in healthcare, lowfrequency ultrasound (20-40 kHz) is a fairly recent addition to the wound care armamentarium. It includes several devices manufactured by various companies that provide different methods of delivering energy to the wound for bactericidal effects and, in some cases, immediate debridement of necrotic tissue. It is also thought to facilitate the wound healing processes.7,8 This modality provides two largely non-thermal effects — cavitation and acoustic streaming. The cavitation phenomenon may be described as the creation of miniscule gas bubbles in tissue fluid and the expansion and contraction in the size of these bubbles in tandem with the variation in the ultrasound field pressure levels. These bubbles implode at certain amplitudes of the sound waves, resulting in the formation of tiny shock waves. These locally generated shock waves, in turn, liquefy

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Figure 1. Wound before use of ultrasoundassisted wound therapy.

Figure 2. Wound after use of ultrasoundassisted wound therapy.

Figure 3. The Ultrasound Generator, part of the MIST Therapy System® by Celleration Inc., Eden Prairie, MN, produces energy needed to create sound waves that are delivered to the wound bed.

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necrotic tissue, other wound debris, and associated biofilm with no negative impact on viable soft tissue or structures.9, 10 Research has shown that such implosion-related shock waves destroy bacterial cell walls.11, 12 Using low-frequency, UAW treatment devices, the built-in lavage system may provide further reduction of cell debris and bacteria to more effectively cleanse the wound site.

The acoustic streaming phenomenon may be described as “temporary disturbances in the cell membranes of the chronic wounds.” Biochemical changes, which in general are beneficial, may arise from such agitations. Included in the biochemical effects are increased cell membrane permeability, increased protein synthesis, mast cell degranulation, increased growth factor production, and enhanced nitric oxide synthetase-mediated cellular mechanisms.13-19 Ultrasound wound management can be described and delivered in various ways. UAW, also referred to as contact, thermal ultrasound, is currently available in the US as three devices (Qoustic Wound Therapy System,™ Arobella Medical, LLC, Minnetonka, MN; Sonic One,® Misonix Ultrasound Surgical Devices, Farmingdale, NY; and Sonoca 180, Söring Medical Technology, North Richland Hills, TX). UAW has been utilized as a wound debridement and cleansing technique for years in the United Kingdom, Russia, and Germany. This technique offers many advantages (see figures 1 and 2): • UAW procedures can be as immediate as sharp or surgical debridement, generally requiring only topical anesthesia; • UAW is selective for nonviable or necrotic tissue, but can be effectively used for excisional debridement; • UAW is bactericidal at the surface and penetrates surrounding tissues; • UAW can be performed in a variety of settings by trained personnel; • UAW procedures allow therapy at the bedside and can be utilized at the time of surgery to provide adjunctive therapy procedures.

UAW utilizes low-frequency pulsed ultrasound directed to the wound sur-

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face and surrounding tissues via an ultrasound probe. Wound irrigation fluid is directed through an opening in the probe’s tip to administer the fluid directly to the wound surface to topically treat the wound base and to serve as a coupling medium, coolant, wound lavage, or flush. In addition to separating dead tissue from the wound bed, UAW features positive wound-healing properties including increased local tissue perfusion via vasodilation and resolution of vasospasm (thermal effect); fibrinolytic division and debridement of denatured proteins; and decreased bacterial load and stimulation of fibroblasts, macrophages, and endothelial cells.

UAW also provides thermal and nonthermal therapeutic effects related to the energy created by the ultrasound wave on the targeted tissue. The body absorbs a percentage of the ultrasound, generating heat and thermal energy as the ultrasound travels through body tissue. The degree of absorption depends on the nature of the tissue, the extent of blood flow, and the frequency of the sound wave. Thermal effects include increased blood flow, reduction in muscle spasm, increased extensibility of collagen fibrils, and a proinflammatory response.20, 21 Ultrasonic treatment has been proven to eradicate surface and adjacent tissue colonization of bacteria; therefore, individuals with a history of frequent cellulitis caused by multiple resistant bacteria may benefit from the reduced need for systemic antibiotics. Collaborative work done by Pierson and Niezgoda22 has emphasized the benefits of UAW treatment: Staff at Brooke Army Medical Center, Fort Sam Houston, TX, isolated 25 highly antibiotic-resistant Acinetobacter ssp. (primarily A. baumannii) from wounded Iraq soldiers. Using a previously described protocol for an in-vitro model, the bacterial suspension was set to a 0.5 McFarland standard before being serially diluted to approximately 100,000 CFU/mL. Initial colony counts were taken prior to sonocation and test solutions were treated with sonocation at 60% output in 10-second bursts, followed by 50-second cool-down periods

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managingpain until a total of 120 seconds of sonocation was achieved. Aliquots were then taken and plated after each 20 seconds of sonocation. Bacterial death was measured by both colony counts after 24 hours of growth and acridine orange staining using a standard protocol. After UAW treatment, a significant log decrease in bacterial load was noted, with less than 5% viable bacteria identified after 120-second treatment.

Low-Frequency Ultrasound

Non-contact, low-frequency ultrasound (NLFU) (MIST Therapy® System, Celleration Inc., Eden Prairie, MN), see Figure 3, utilizes acoustic/ sound energy to atomize saline and deliver ultrasound energy by way of a continuous mist to the wound bed and surrounding tissue, without direct contact with the wound bed.

The sequence of events begins with electrical energy being converted to a mechanical displacement. The oscillation of the tip creates an acoustic pressure wave and atomizes the sterile saline. The saline mist supports the efficient transfer of energy and promotes coupling of energy into the wound bed. This cascade of events creates a biological response including, but not limited to, a reduction of bacteria, eradication of biofilm, down regulation of inflammatory cytokines, and cellular stimulation.

There is some common terminology used when referring to ultrasound therapy: Frequency is defined as the number of vibrations per second. The frequency of the non-contact, non-thermal ultrasound energy is 40 kHz.That translates to 40,000 vibrations per second.

The wavelength is the distance between two equivalent points on the waveform.

NLFU wavelength is 3.75 cm.

The velocity is the speed with which the wave travels through the medium.

Sound energy travels 1500 m/sec in water as compared to 350 m/sec in air.

The NLFU intensity measures in the therapeutic range of 0.1-0.7 W/cm.2 The uniqueness of the device is the non-contact and painless delivery of ul-

Figure 4. Venous Leg Ulcer Baseline and at the conclusion of 12 treatments: 3 times per week for 4 weeks.

Present for > 6 months. Failed to improve in the previous 30 days with compression bandage and standard of care. 12 MIST Therapy® treatments.

Escandon J, University of Miami, 2012

trasound energy, with an FDA indication to promote wound healing. A recently published meta-analysis23 addresses the clinical effectiveness of NLFU. This analysis included eight peer-reviewed studies with heterogeneous populations that were found to be consistent in both the treatment and control groups. The data was pooled to review the effects of NLFU on wound size, volume, pain, and healing time.

Summary of findings: • 85.2% area reduction in 7 weeks;

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• 79.7% volume reduction in 12 weeks; • 42% healed at 12 weeks (mean time to heal of 8.2 weeks); • 79% pain reduction.

The pain reduction data found during the meta-analysis provides the basis for an interesting discussion. Pain associated with chronic wounds and wound care therapies is a continual clinical challenge in patient care.We have few interventions aside from medications to address pain.

While the NLFU device is not cleared by

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managingpain the FDA as a pain-reduction therapy, there have been clinical observations in which patients with painful, chronic lower-extremity wounds reported a reduction in wound pain shortly after ultrasound therapy was initiated. Samies et al24 did a retrospective chart review and analysis of reported pain scores from records of 15 consecutive patients (eight women and seven men ages 28-88) with painful, nonhealing, lower extremity wounds treated for 2-4 weeks with NLFU. The mean pain scores decreased from 8.07 (± 1.91) pre-treatment to 1.67 (±1.76) post-treatment (P = 0.0003). No patients reported worsening pain after treatment commenced.

Promoting Wound Closure

Bacteria and chronic inflammation certainly provide the background for increased pain. Generally, bacteria/infections are clinically treated with antimicrobial scrubs and dressings and/or oral antibiotics. It has become increasingly evident that the problem within the chronic and acutely chronic wound is inflammation, bacteria, and biofilm. Serena25 looked at the impact of NLFU bacteria in a multicenter trial that assessed 11 patients living with Stage III pressure ulcers showing no clinical signs of acute infection.

The pre-treatment bacteria loads were >105 CFU/g tissue. There were 13 different types of bacteria cultured from pre-treatment punch biopsies. Each subject received six NLFU treatments for 2 weeks before being biopsied again. There was >93% reduction in the bacteria postNLFU treatments. Also noted was a 26% reduction in wound size in 2 weeks.

An open-label pilot study conducted at the University of Miami of 10 refractory venous ulcers of large size to determine the effect of non-contact ultrasound on wound closure, bacterial counts and expression of inflammatory cytokines.

Researchers compared the baseline and end-of-treatment assessments and found a significant reduction in wound area, 45% (P = 0.0039) over the 4-week treatment period (see Figure 4). They also found a decline in individual and total bacterial counts; however, these differences were

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not significant. For all patients, there was also a trend toward reduced inflammatory cytokine expression compared to baseline levels; however, this reduction did not reach statistical significance.

Interestingly, there was a correlation between healing and change in cytokine expression that showed statistical significance for TNF-α (P = 0.0395), IL-1a (P = 0.0351), IL-6 (P = 0.0508), IL-8 (P = 0.0990).26 The wound team at Boston University Medical Center conducted a randomized, controlled pilot study on 12 patients living with nonhealing diabetic foot ulcers. The aim of this study was to evaluate the relationship between dose and duration of treatment by evaluating clinical changes and investigating systemic inflammatory response by quantifying cytokine activity. The patients were randomly assigned to one of three groups (NLFU 3 times per week, NLFU 1 time per week, standard of care. Group 1 showed significant wound reduction at weeks 3, 4, and 5 compared to baseline, with the greatest percent area wound reduction (PAR) 86% (P<0.05). Groups 2 and 3 showed 25% PAR and 39% PAR, respectively, but there are no statistical differences between group 2 and group 3 over time. Biochemical and histological analysis indicated a trend of reduction of proinflammatory cytokines (IL-6, IL8, IL-1β, TNF-α, and GM-CSF), matrix metalproteinase-9 (MMP-9), and macrophages in response to LFNC-US that is consistent with wound reduction when compared to control group subjects.27

NLFU Therapy

Currently, a research team at Northwestern University is assessing the impact of NLFU therapy on biofilm.The aim of this preliminary study is to evaluate the efficacy of NLFU in the treatment of biofilm-infected wounds using the wellestablished, in vivo, rabbit ear wound biofilm model.

The experiment included both a daily treatment group and one every other day.

NLFU wounds from both treatments resulted in significant improvements in epithelial gap and granulation gap, as well

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as an increase in total granulation area.

Viable bacterial counts were measured for both treatment groups relative to untreated wounds and resulted in significant improvements in wound bacterial burden relative to untreated wounds.

Controversy still exists regarding the significance of bacteria in nonhealing wounds. While healing occurs despite the presence of microorganisms, it is possible the density of microorganisms, how bacteria exist, or the presence of specific pathogens is critical to determine whether or not a wound will heal.

High microbial burden leads to the presence of neutrophils in the wound, which perpetuates an inflammatory environment with release of cytotoxic enzymes, free oxygen radicals, and matrix metalloproteinases (MMPs). Excessive MMPs degrade the extracellular matrix, may inhibit cell migration, and prevent wound closure. As a result, bacterial proliferation and colonization may retard wound healing. NLFU therapy is thought to promote healing in chronic wounds by removing bacteria and cleansing and debriding devitalized tissue, fibrin, and exudates. NLFU is also uniquely positioned to accelerate healing because of its ability to reach cells below the wound surface. This study, conducted in pigs, demonstrated NLFU’s ability to penetrate below the surface of both intact and wounded skin.

Nile red dye was added to the saline solution of the NLFU and a sham device.The dye, a standard solution used in similar experiments because of its strong lipophilic properties and strong fluorescence, was mixed into the saline canister of the NLFU and sham device to achieve a final concentration of 0.01%.

When fully analyzed, the concentration of dye penetration was at 3.0-3.5 mm on wounded skin and 2.0-2.5 mm on intact skin as compared to 0.35-0.50 mm on wounded skin and 0.05-0.07 mm on intact skin with a sham device.23 Given the most recent developments in research projects assessing the mechanism within the wound, one should give thought to the following: The NLFU device delivers a low-pressure, high fre-

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managingpain quency saline spray. One would hypothesize that the positive effects from the device are not due to shearing or mechanical forces. Instead, it may be that the ultrasonic frequency of the delivery system is disrupting the structure of the biofilm formed by the wound bacteria.

This may then allow the host to overcome an otherwise difficult wound infection. Another potential, or additional, mechanism may be that NLFU is stimulating the host wound-healing response, restoring balance within the wound bed to a point that it is able to overcome the biofilm, bacteria, and/or inflammation present within the wound. n Dot Weir is co-editor of Today’s Wound Clinic. Pamela G. Unger is vice president of medical affairs and clinical education at Celleration, Inc. REFERENCES

1. Martin LK. Wound microbiology and the use of antibacterial agents. In: Falabella AF, Kirsner RS, eds.

Wound Healing. Boca Raton, FL: Taylor & Francis Group; 2005:83–101.

2. Gardner, SE, Frantz, RA, Doebbeling, BN.The validity of the clinical signs and symptoms used to identify localized chronic wound infection. Wound Rep Reg. 2001; 9:178–186.

3. Selkorn FJ, Cherry GW, Wilson JM, Hughes MA. et al. Evaluation of hypochlorous acid washes in the treatment of chronic venous ulcers. Journal of Wound Care. 2006;15(1).

4. Wang L, Bassiri M, Najafi R, et al. Hypochlorous acid as a potential wound care agent. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burn Wounds. 2007.

5. Buchtala V. The present state of ultrasonic therapy. Br J Phys Med. 1952;15:3-6.

6. S peed CA. Therapeutic ultrasound in soft tissue lesions. Rheumatology. 2001; 40(12):1331-6.

7. Altland OD, Dalecki D, Suchkova VN, Francis CW. Low-intensity ultrasound increases endothelial cell nitric oxide synthase activity and nitric oxide synthesis. J Thromb Haemost. 2004;2:637-43.

8. Suchkova VN, Baggs RB, Sahni SK, Francis CW. Ultrasound improves tissue perfusion in ischemic tissue through a nitric oxide dependent mechanism. Thromb Haemost. 2002; 88:865-70.

9. Ballard K, Charles H. Ultrasound therapy. Nursing Times. 2001; 97(24):58-9.

10. Speed CA. Therapeutic ultrasound in soft tissue lesions. Rheumatology. 2001; 40(12):1331-6.

11. Schoenbach SF, Song IC. Ultrasonic debridement: a new approach in the treatment of burn wounds.

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19. Suchkova VN, Baggs RB, Sahni SK, Francis CW. Ultrasound improves tissue perfusion in ischemic tissue through a nitric oxide dependent mechanism.

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25. Serena T, Lee SK, Lam K, Attar P, Meneses P, Ennis W. The impact of noncontact, nonthermal, low-frequency ultrasound on bacterial counts in experimental and chronic wounds. Ostomy Wound Manage. 2009; 55(1):22-30.

26. Escandon J, et al. A prospective pilot study of ultrasound therapy’s effectiveness in refractory venous leg ulcers. Int Wound J. 2012;doi:10.1111/j.174248X.2011.00921.x.

27. Fabbi M, et. al. Clinical effects and underlying molecular mechanisms of noncontact low-frequency ultrasound on diabetic foot ulcers. DLS. 2011.

28. Stillwell G. Ultraviolet therapy. In: Krusen F, ed.

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29. Fischer E., Solomon S. Physiologic effects of ultraviolet radiation. In: Licht S, ed. Therapeutic Electricity and Ultraviolet Radiation. Baltimore: Waverly Press, 1959: 273-275.

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Stanisic M, Provo B, Larson D, Kloth L.Wound debridement with 25 kHz ultrasound. Advances in Skin and Wound Care. 2005; 18:9, 484-490.

Breuing KH, Bayer L, Neuwalder J, Arch M, Orgill DP. Early experience using low frequency ultrasound in chronic wounds. Ann Plast Surg. 2005;55:183-7.

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Driver VR, Yao M, Miller CJ. Noncontact lowfrequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Wound Repair and Regeneration. 2011;19 (4):475–480.

Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multi-center study. MIST Ultrasound Diabetic Study Group. Ostomy Wound Manage. 2005;51(8):24-39.

24. Gehling ML, Samies JH. Unanticipated palliative benefit of noncontact, low-intensity, low-frequency therapeutic ultrasound on lower extremity chronic wound pain. Ostomy Wound Manage.

Sibbald GR, Williamson D, Orsted HL, et al. Preparing the wound bed – debridement, bacterial balance and moisture balance. Ostomy Wound Manage. 2000; 46: 14-35.

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2007;53(3):44-50.

Today’s Wound Clinic®

May 2012

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The symposium on

adv an ced wound care

SAWC FALL

ÂŽ

AAWC

The official meeting site of the Association for the Advancement of Wound Care

2012

September 12â&#x20AC;&#x201C;14 B altimore Convention Center B altimore,

Maryland

The Premier Meeting For Wound Clinic Professionals

O

ver the last quarter century, the S ymposium on Advanced Wound Care (S AWC) has become internationally known as the premier educational program for clinicians who specialize in wound care.

The recent emergence of S AWC Fall ensures that no one will miss out on the high quality, up-to-date education that clinicians have come to expect from the S AWC S pring conference. There has been a tremendous response from attendees and exhibitors to S AWC Fall over the past three years and we expect to provide another outstanding conference with S AWC Fall 2012 in Baltimore.

Register now for incredible super saving rates and possible MVP benefits!

In addition to tracks on translating science to practice and advanced treatment of difficult wounds, SA WC Fall offers a dedicated track for those who practice at wound care clinics. O verall, S AWC Fall offers up to 16 contact hours for clinicians, 41 new clinical sessions and hosts a major exhibition of the latest products and innovations in wound care.

We look forward to seeing you at SA WC Fall 2012 in B altimore!

R obert Kirsner, MD, PhD V ice Chairman and S tiefel Laboratories P rofessor D epartment of D ermatology and Cutaneous S urgery U niversity of Miami Miller S chool of Medicine Miami, FL

D ot Weir, RN , CWON , CWS Clinical Coordinator, Wound Care O sceola R egional Medical Center Kissimmee, FL

For more information about this meeting, visit www.sawcfall.com or call 800-237-7285, ext. 233.

SAWC_FALL_2012_2-PAGE_TWC2.indd 2

Che ck u s out on:

4/13/12 12:53 PM

Provo cative Se ssion s Y ou Won’t Find A t O ther Wound Care Con feren ce s

E ndorsed by the

• D o Wound Clinics Benefit P atients?

• Inflammatory U lcers And U nusual Wounds: H ow D o I D iagnose And Manage Them?

• E merging Treatments For D iabetic Foot U lcers • Applying The S cience Behind O ffloading The Foot • H BO T: R emoving The Mythology • H ow To N avigate Wound Care Clinic And O ffice P olitics • To S tretch O r N ot To S tretch: The S cience O f Compression Therapy For V enous And Lymphatic D iseases • Keys To Facilitating P ost-Amputation R ehabilitation • Getting P aid: The Finances O f Wound Care • R eality Check: What Y ou S hould Know About P alliative Wound Care

Who Should

A ttend

This conference is designed for physicians, researchers, podiatrists, nurses, physical therapists and dietitians involved in wound healing or wound care issues. S AWC Fall provides attendees who study and treat wounds with state-of-the-art reviews of clinical problems and research information.

L earning

O bje ctive s

After attending this conference, participants should be able to do the following: • Appraise the evidence base of commonly used wound management strategies • E xplore the realities of delivering healthcare beyond clinical issues such as wound clinic office politics and the finances of wound care • P rovide optimal healthcare delivery through improved understanding of sites of service and payment schema • Illustrate key factors that may delay or inhibit wound healing • E xamine proven and emerging scientific rationale behind wound care principles and how to translate them to clinical practice • D iscuss the latest advances in current and emerging diagnostic and healing techniques, and review ongoing or recently completed trials involving wound therapies • R ecognize the mechanisms behind the development of unusual wounds • Assess current and emerging healing techniques in wound care • Investigate critical elements associated with proper management of unusual and pediatric wounds, and review ongoing or recently completed clinical trials involving wound therapies

Acc reditation In formation In support of improving patient care, N orth America Center for Continuing Medical E ducation, LLC (N ACCME ), is accredited by the Accreditation Council for Continuing Medical E ducation (ACCME ), the Accreditation Council for P harmacy E ducation (ACPE ), and the American N urses Credentialing Center (AN CC) to provide continuing education for the healthcare team.

Physicians: N orth American Center for Continuing Medical E ducation, LLC (N ACCME ), designates this live activity for a maximum of 16 AMA PRA Category 1 Credits™. P hysicians should claim only the credit commensurate with the extent of their participation in the activity.

N urses: This continuing nursing education activity awards 16.0 contact hours.

P rovider approved by the California Board of R egistered N ursing, P rovider N umber 13255 for 16.0 contact hours.

Podiatrists: N orth American Center for Continuing Medical E ducation, LLC (N ACCME ), is approved by the Council on P odiatric Medical E ducation as a sponsor of continuing education in podiatric medicine. This program is approved for 16 contact hours.

Dietitians: N orth American Center for Continuing Medical Education, LLC (N ACCME), is a Continuing Professional Education (CPE ) Accredited Provider with the Commission on D ietetic R egistration (CDR ). R egistered dietitians (RD s) and dietetic technicians, registered (D TR s) will receive 16 continuing professional education units for completion of this program.

CDR Accredited P rovider #HM 001 Level 3 S ynthesis Level Physical T herapists: N orth American Center for Continuing Medical E ducation, LLC (N ACCME ), will apply for pre-approved accreditation in Florida, Louisiana, N evada, O hio, and Texas which require pre-approval. N ACCME will apply for pre-approval in California for targeted sessions. If you practice in another state, please consult your P T board.

For questions regarding this educational activity, please call 609-371-1137.

H ardware/Software R equirements: All educational activities are accessible via a P C (Windows 2000/XP / V ista/7) or Mac (Mac OS 10.x or later) computer with current versions of the following browsers: Internet E xplorer, Mozilla Firefox, Google Chrome or S afari.

Windows Media P layer or compatible alternative, sound card, and speakers are required for streamed audio. The latest version of the Adobe Flash P layer is suggested (please download here) for video programs. A PD F reader is required for print publications. P lease direct technical questions to webmaster@naccme.com.

R equirements for Credit: To be eligible for documentation of credit for each session attended, participants must participate in the full activity and complete the online general survey and the online evaluation form for each session by O ctober 14, 2012.

Complete the forms at www.myexpocredits.com/ naccme; once done, participants may immediately print documentation of credit.

Privacy Policy: N ACCME protects the privacy of personal and other information regarding participants, educational partners, and joint sponsors. N ACCME and our joint sponsors will not release personally identifiable information to a third party without the individual’s consent, except such information as is required for reporting purposes to the appropriate accrediting agency.

N ACCME maintains physical, electronic and procedural safeguards that comply with federal regulations to guard your nonpublic personal information.

Copyright © 2012 by N orth American Center for Continuing Medical Education, LLC. All rights reserved. N o part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from N orth American Center for Continuing Medical Education.

ADA Statement: N orth American Center for Continuing Medical Education complies with the legal requirements of the Americans with D isabilities Act and the rules and regulations thereof. If any participant in this educational activity is in need of accommodations, please call 609-371-1137.

IN FORMATION CONTAINED HEREIN IS SUBJE CT TO CHANGE WITHOUT NOTI CE .

Che ck u s out on: For more information and a full list of sessions, please visit www.sawcfall.com

SAWC_FALL_2012_2-PAGE_TWC2.indd 3

4/13/12 12:53 PM

E-Stimulation:

An Effective Modality to Facilitate Wound Healing Pamela Scarborough, PT, DPT, MS, CDE, CWS, CEEAA; and Luther C. Kloth PT, MS, FAPTA, CWS, FACCWS

E

very action in the body, from the cellular level to the level of gross motor function, begins as an electrical impulse. Exogenously applied electrical energy is something any wound care clinician should consider using to augment what is already a function of natural healing. When it comes to chronic wounds, electrical stimulation (ES), one of several biophysical technologies, is known by those healthcare providers who employ its use to be one of the most cost effective, therapeutically efficacious tissue repair and wound healing accelerators in the industry today.1 By restoring the natural electrical potentials necessary for cellular activities that have become

28

stalled, ES re-establishes and intensifies healing processes.2,3 There has been substantial research regarding the effects of ES on the cellular and physiological mechanisms that enhance wound closure and healing.4 This article does not attempt to describe the evidence in detail; rather, the authors summarize the overall effects of ES on chronic wounds in an effort to familiarize clinicians with this underused efficacious treatment modality.

Types of Electrical Current

There are three types of electrical current that assist in wound closure and healing: direct current (DC), alternating current, and pulsed current (PC).

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The majority of clinical trials using ES currents for wound healing have used PC delivered in either monophasic- or biphasic-pulsed waveforms, whereby current is delivered to the wound via a number of pulses per second (pps).

There are three variations of PC that have been reported to augment chronic wound closure and healing. They are: • high-voltage monophasic-pulsed current, frequently referred to as hivolt pulsed current (HVPC); • low-voltage monophasic-pulsed current; and • low-voltage biphasic-pulsed current (LVBPC).

LVBPC is employed in transcutaneous electrical nerve stimulation (TENS)

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managingpain Table1: Enhanced Cellular Motility/Electrotaxis in DC and PC Electric Fields4 Phase of Healing

Biological Effects

Cells

Cells Enhanced Motility to:

Inflammatory

Phagocytosis and autolysis

Macrophage Neutrophil Neutrophil Activated neutrophil

DC (+) DC (+) PC (+) DC (-­)

Proliferative

Fibroplasia

Fibroblast Fibroblast Keratinocytes

PC (-­) DC (-­) DC (-­)

Remodeling

Wound contraction Epithelialization

Myofibroblast Epidermal

PC (-­) DC (-­)

Adapted from Kloth L. Endogenous and Exogenous Electrical Fields for Wound Healing. In: McCulloch JM, Kloth LC, eds. Wound Healing: Evidence-Based Management. 4th ed.

Philadelphia, PA: FA Davis Company; 2010:450-513.

devices, primarily for pain control.4 At present, HVPC is the current most supported by the evidence for wound healing and is most frequently used for this purpose in the US. HVPC devices provide choices for polarity and pulsed frequency, which are known to affect cell behavior in and near the wound bed.4

ES Action on Cells and Tissue

Chronic wounds become stalled somewhere between the inflammatory and proliferative phases, often requiring assistance to restore the wound to the beginning of the inflammatory phase (so as to proceed through the proliferative phase and on to the maturation phase). Functioning cells are required for granulation tissue formation, wound closure, and subsequent healing through the maturation phase. Neutrophils and macrophages clean the wound and help decrease bioburden to prevent infection. Fibroblasts are the “workhorse” cells that build granulation tissue, and keratinocytes resurface the wounds.

Early in vitro studies4-8 suggested cells involved in wound healing have their own inherent charge, and thus would be attracted to a treatment electrode having opposite polarity. More recent research has shown the motility of cells involved in wound healing can be enhanced by exogenously applied electrical fields; however, cell migration is not influenced in the same way that a charged particle (ion) is affected by

Table 2: Effects of ES on Wound Closure & Healing Fields Electrical stimulation has multiple effects applicable to wound closure and healing.

Research has demonstrated that application of ES energy: • Upregulates

insulin receptors on fibroblasts (Significance: If insulin is available to bind additional receptors, fibroblasts will significantly increase both protein and DNA synthesis.)4 • Results in upregulation of TGF-­β4,10 • Increases angiogenesis11 • Decreases bacterial burden12,13 • Increases survival of grafts and flaps (in animal models)4 • Increases blood flow4,14 • Increases wound tensile strength15,16

Table 3: Wound Types That May Benefit From ES Application There have been many clinical studies demonstrating the efficacy of ES energy to facilitate chronic wound closure and healing. Many, if not most, wound etiologies benefit from the application of ES energy. The types of wounds that have demonstrated improvement using ES include:

1. Pressure ulcers3,4,17-­19 2. Venous insufficiency leg ulcers20-22 3. Arterial insufficiency ulcers4,21,22 4. Diabetic neuropathic foot ulcers23,24 5. Dehisced surgical wounds4 6. Failing flaps and grafts4

electrical forces (Table 1).4,9 (For a sample of devices that deliver HVPC applicable for wound healing, visit www.todayswoundclinic.com beginning May 9. Note: This is a small sample and is not intended to be comprehensive regarding the devices available for sale and use.) Tables 2 and 3 describe the effects of ES on wound closure and healing, and the types of

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wounds that may benefit from ES application, respectively.

Using ES For Wound Closure4

Although several factors appear to affect cell movement in the wound bed using electrical currents, the choice of the polarity of the wound treatment electrode should be based on reports from clinical outcomes and best practice.

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managingpain E-­Stimulation: Case Presentations 1) 67-­year old male with 10-year history of diabetes. Presents with L-heel pressure ulcer due to immobility after hospital stay and transmetatarsal amputation L-­foot (transmet wound not closing). Previous femoral popliteal bypass. ABI: .53. Goal: Prevent future amputations of L-­foot, fitting of shoe for L-­foot for functional home and community ambulation. Outcome: Complete closure heel and transmetatarsal site in 6 weeks using ES. Fitted with custom insert and shoes. Returns home from facility after rehabilitation.

Patient prone

Patient supine

Slow-healing amputation incision same foot

ES Stocking Delivery

2) 89-­year-old female with 25-year history of diabetes. AKA L-­leg, previous amputation of 2nd, 3rd, and 5th toes R-­foot.

Goal: Keep R-­foot/leg for functional bed/wheelchair/shower-­chair/commode transfers. ABI: .46. Wound closed 8 weeks with ES stocking delivery method.

(P. Scarborough)

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managingpain When using ES, the clinician introduces the current into or near the wound by setting the parameters on the device to facilitate the outcomes desired. Many ES device manufacturers preset some of these parameters to simplify treatment application. The following suggestions relate to parameter selection: Settings: • Pulse frequency: 100 pps.

• Pulse duration: 20-100 µsec (usually fixed by the manufacturer).

• Polarity: A positive or negative polarity is introduced into the wound bed and is chosen by the clinician depending on wound healing phase and desired effects. In general, starting with negative polarity is recommended when the goal is to enhance granulation tissue formation in the wound bed and when re-epithelialization is desired. Positive polarity is chosen to enhance antimicrobial effects.

• Additional suggestions for polarity introduced into the bed of a noninfected wound: oN egative: Begin with negative polarity as long as the wound shows improvement as evidenced by continued granulation tissue deposition, decrease in wound size, and decrease in exudate. o Positive: If the wound stalls or regresses, change to positive polarity and continue as long as the wound shows improvement. o Negative: Change back to negative polarity if there is no healing progress. Maintain negative polarity for 7-14 treatments, as long as healing progress continues.

• Treatment duration and frequency: 45-60 minutes, 5-7 days per week or at least 3 days per week if possible. Treat until wound closes.4

Contraindications, Precautions

There are several methods for introducing exogenous ES currents into

the ulcer area, including: • Direct or monopolar arrangement: The treatment electrode is placed directly into or over the wound; the non-treatment (dispersive) electrode is placed on intact skin.

• Indirect bipolar arrangement: Two electrodes straddle the wound area on intact skin.

• Stocking or glove electrode garment applied to the affected limb.

Although ES is appropriate for many wound etiologies, there are considerations that need to be made. For patients with intact sensation, the initial electrical current can be startling.

Therefore, the clinician should alert the patient when starting the device and increase the intensity gradually, monitoring the patient’s response until the desired intensity is reached. There have been reports of skin irritation under the non-treatment electrode. This irritation may occur when using a device with a continuous DC component. Skin irritation usually does not occur with PC. If skin irritation does occur, it is usually a transitory issue.4 Contraindications for ES include the presence of basal or squamous cell carcinoma in the wound or periwound tissues, or melanoma, as ES may increase cancer cell activity. Untreated osteomyelitis should not be treated with ES, as the wound may close while the infection is present. ES should not be placed over the pericardial area, carotid sinus, phrenic nerve, parasympathetic nerves, or ganglia; muscles of the larynx (an exception is VitalStim,® Therapy System, Empi, St. Paul, MN; used by speech-language pathologists for dysphagia); or any type of external or implanted electronic pacemaker device.4 ES should not be placed directly over the pregnant uterus, as the effects on the fetus are unknown.

Studies have examined wound-related pain being modulated by ES currents including TENS, HVPC and interferential currents.25,26 By primarily using the visual analogue scale, several investigators demonstrated a statistical improvement in wound-related pain

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reported by patients in these studies.25 In addition, patients who have had ES used on their wounds frequently describe their wound pain as being a decrease from an anecdotal perspective. In 2000, the Paralyzed Veterans of America published a clinical practice guideline, Pressure Ulcer Prevention and Treatment Following Spinal Cord Injury,18 which stated that ES qualified as a stand-alone intervention and was no longer classified as an adjunctive therapy. In addition, this energy has been recognized by the National Pressure Ulcer Advisory Panel as an adjunctive therapy for the treatment of recalcitrant category/stage III and IV pressure ulcers.17 n

Editor’s Note: For coding, coverage, and payment information, please see Business Briefs on page 6.

Pamela Scarborough is director of public policy and education at American Medical Technologies. Luther C. Kloth is emeritus professor of the physical therapy department at Marquette University and co-editor/author of Wound Healing: Evidence-Based Management, 4th ed., published by F.A. Davis Company, Philadelphia, 2010.

TWC Online Exclusive:

Examples of ES Devices that complement this article can be found online beginning May 9.

Visit:

www.todayswoundclinic.com.

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managingpain REFERENCES 1.

Baranoski S, Ayello EA. In Wound Care Essentials: Practice Principles; pp 200-201.

2. Kloth L, McCulloch J. Promotion of wound healing with electrical stimulation. Adv Wound Care. 1996;9(5):42-54.

3. Franek A, Kostur R, Polak A,Taradaj J. Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized controlled clinical study. Ostomy Wound Manage. 2012; 58(3):30-44.

4. Kloth L. Endogenous and Exogenous Electrical Fields for Wound Healing.

In: McCulloch JM, Kloth LC, eds.

Wound Healing: Evidence-Based Management. 4th ed. Philadelphia, PA: FA Davis Company; 2010:450-513.

5. Dineur, E. Note sur la sensibilities des leukocytes a l’electricité. Bull Seances Soc Belge Microscopic (Bruxelles) 1891; 18:113.

6. Fukushima, Gruler KH. Studies of galvanotaxis of leukocytes. Med J Osaka Univ. 1953; 4:195.

7. Monguio, J. Uber die polare wirkung des galvanischen stromes auf leukozyten. Z Biol. 1933; 93:553–556.

8. Orida N, Feldman JD. Directional protrusive pseudopodial activity and motility in macrophages induced by extracellular electric fields. Cell Motil. 1982; 2:243–255.

11. Greenberg J, et al. The effect of electrical stimulation (RPES) on wound healing and angiogenesis in seconddegree burns. Abstract No. 44. In Program and Abstracts of the 13th Annual Symposium on Advanced Wound Care, Dallas, TX, April 1–4, 2000.

12. Merriman HL, Hegyi CA, AlbrightOverton CR, et al. A comparison of four electrical stimulation types of Staphylococcus aureus growth in vitro.

Rehabil Res Develop. 2004;41(2):139146.

13. Daeschlein G,Assadian O, Kloth LC, et al. Antibacterial activity of positive and negative polarity low-voltage pulsed current (LVPC) on six typical grampositive and gram-negative bacterial pathogens of chronic wounds. Wound Rep Regen. 2007; 15:399-409.

14. Goldman R. Electrotherapy promotes healing and microcirculation of infrapopliteal ischemic wounds: a prospective pilot study. Advances in Skin and Wound Care. 2004;17.

Mehmandoust FG, Torkaman G, 15.

Firoozabadi M, Talebi G. Anodal and cathodal pulsed electrical stimulation on skin wound healing in guinea pigs.

J Rehabil Res Dev. 2007; 44(4):611-8.

16.

Brown M, Gogia P. Effects of high voltage stimulation on cutaneous wound healing in rabbits. Phys Ther.

1987;662-667.

MA. 9.

Robinson

KR, Messerli Left/right, up/down: The role of endogenous electrical fields as directional signals in development, repair, and invasion. Bioessays. 2003; 25:759–766.

17. Biophysical Agents in Pressure Ulcer Management, National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel. Prevention and treatment of pressure ulcers: clinical practice guideline.Washington, DC: National Pressure Ulcer Advisory Panel; 90-91, 2009.

10. Falanga V, Bourguignon GY, Bourguignon LYW. Electrical stimulation increases the expression of fibroblast receptors for transforming growth factor-beta. J Invest Dermatol.

1987;88:488-492.

18. Garber SL, et al. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health care professionals. Consortium for Spinal Cord Medicine Clinical Practice Guidelines. Washing-

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ton, DC: Paralyzed Veterans of America, 2000.

19. Houghton PE, Campbell KE, Fraser CH, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil. 2010;91(5):669-78.

20. J ünger M, Arnold A, Zuder D, Stahl HW, Heising S. Local therapy and treatment costs of chronic, venous leg ulcers with electrical stimulation (Dermapulse): a prospective, placebo controlled, double blind trial. Wound Repair Regen. 2008 Jul-Aug;16(4):480-7.

21. American Society of Plastic Surgeons (ASPS). Chronic Wounds of the Lower extremity. 2007. http://guideline.gov.

Accessed April 15, 2012.

22. Houghton PE, Kincaid CB, Lovell M, Campbell KE, et al. Effect of electrical stimulation on chronic leg ulcer size and appearance. Phys Ther.

2003;83(1):17-23. http://ptjournal. apta.org. Accessed April 15, 2012.

23. Baker LL, Chambers R, DeMuth SK, et al. Effects of electrical stimulation on wound healing in patients with diabetic ulcers. Diabetes Care. 1997; 20:405–412.

24. Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial. Arch Phys Med Rehabil. 2001 Jun;82(6):721-5.

25. Jankovc A, Binic I. Frequency rhythmic electrical modulation system in the treatment of chronic painful leg ulcers. Arch Dermatol Res. 2008;300(7):377-83.

26. Blum K, DiNubile NA,Tekten T, et al.

H-wave, a nonpharmacologic alternative for the treatment of patients with chronic soft tissue inflammation and neuropathic pain: a preliminary statistical outcome study. Adv Ther. 2006; 23(3):446-455. www.todayswoundclinic.com

5/4/12 3:31 PM

industryinsider An Inside Look at Intellicure Inc.

T

his month, we interview Caroline Fife, MD, FAAFP, CWS, chief medical officer.

Today’s Wound Clinic (TWC): How long have you been in wound care, and how did you enter this area of healthcare?

Caroline Fife (CF): I’ve spent nearly a quarter century in the full-time practice of wound care,beginning with my fellowship in undersea and hyperbaric medicine at Duke in 1988.

While at Duke, I spent time with Claude Burton, who Caroline Fife, MD, developed the “Duke FAAFP, CWS Chief Medical Officer, Boot” for venous leg Intellicure Inc. ulcers. His clinic was the inspiration for the wound center I began at University ofTexas Health Science Center in 1990. It was the first wound center in Houston and continues to serve the many institutions within Texas Medical Center.

When the Medicare guidelines for physician documentation were published, it seemed obvious that the system was so complicated that no doctor could consistently determine the correct level of service for a patient visit. I began working on a computer system to calculate the physician level of service,later joining forces with DavidWalker, who had already computerized hyperbaric documentation requirements.

In 1997, the Memorial Hermann Wound Center went“live”online with the first generation of what became Intellicure, making us the first wound center in the US to have an electronic platform. David and I later developed and validated a method for facility billing via “acuity scoring.”The electronic health record (EHR) internally audits the chart based on the nurse’s docu-

mentation and calculates the facility charge at the same time it is calculating the physician charge, so clinicians and institutions can be confident their documentation will support the charges they generate.

TWC: What are your highest-selling products or services?

CF: Intellicure 5.1. Our certified electronic health record (EHR) is popular because we ensure documentation compliance and medical record security. The ability of Intellicure to internally audit the record and calculate physician- and facility-level of service is a necessity for confident and compliant charge processing. Physicians are more likely to capture their HITECH adoption money since we offer the most options for meaningful use reporting, allowing providers to demonstrate up to 25 core and five menu-set objectives to qualify for incentive payment.

Once the electronic documents representing the clinical chart are generated, they are locked against subsequent alteration, stored, and secured just as you would have stored and secured paper documents (a requirement according to the Health Information Management Systems Society [HIMSS]).

LCD (Local Coverage Determination) Defender. This software product ensures expensive procedures, such as bioengineered skin,contain the elements needed for compliant documentation. Our unique internal calculations for debridement automatically select the correct paired codes based on wound size and percent debrided. We also ensure the physician’s and the facility’s documentation for debridement correlate.

These unique safeguards protect facilities and physicians from potential repayments due to poor documentation should they

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undergo an audit by a Recovery Audit Contractor (RAC). The increasing scrutiny of wound centers by RACs is making LCD Defender popular.

Medical Quality Assurance (MQA). Clinics can contract for medical review of all initial consultations for a defined period of time. MQA fills a need for further wound care training after physicians have completed introductory courses.

TWC: Describe your day-to-day role.

CF: When I’m not practicing clinical medicine,I support the ongoing design and development of the Intellicure EHR so that it continues to be the best clinical documentation system. A major focus of my work is the incorporation of clinical practice guidelines to help standardize wound care. I work with our development team to expand our interactive quality-reporting features that allow stakeholders to find missed opportunities for improvement.

TWC: Why are you passionate about the work of your company?

CF: In 2005, Intellicure provided the data to CMS officials that demonstrated their proposed plan to reimburse wound centers by wound size would not result in a fair distribution of charges.

We created, validated, and published an alternative billing structure, which we termed “acuity scoring,” (a measure of staff work) that is now the most common method of wound center billing.

We are passionate about improving quality of care with our decision-support tools, thus decreasing total cost of care. We can measure patient outcomes with our interactive reports and benchmarking services.

Because of its internal charge auditing, Intellicure is the ideal documentation system for future accountable care organizations.

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industryinsider TWC: How would you describe the overall mission of your company?

CF: To harness information technology to improve healthcare. This means ensuring patients have the best possible outcomes by making decision support available at the point of care and tracking physician compliance with practice guidelines.

Our goal is to optimize physician and facility revenue while improving value by decreasing waste. We also seek to advance the frontiers of knowledge with comparative-effectiveness studies based on real-world data.

Our mission is to assist providers in harnessing technology to optimize patient care. Our goals are to provide the tools needed to deliver evidence-based care, ease concerns regarding billing and coding, facilitate clinical research, and make life easier. Intellicure was developed by clinicians, for clinicians. Every software feature, clinical document, and management report was built to answer a burden or meet a real need while running a wound care and hyperbaric center.

TWC: What’s most rewarding about providing for your industry?

CF: We help clinicians take better care of patients. We believe making decision support available at the point of care and providing clinicians with report cards on quality measures will improve patient outcomes and reduce cost. Through MQA we ensure specific patients who might have rare or particularly challenging problems get oversight from more experienced practitioners.

With our internal chart billing functions and auditing services, we ensure practitioners are reimbursed fairly for the work they provide and are protected against subsequent recoupment.With the US Wound Registry, we can advance the frontier of medical science to determine which modalities offer the most benefits in the treatment of the challenging patients we care for.

Thus, the way in which Intellicure has harnessed technology can improve the lives of patients and the clinicians who care for them.

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TWC: How is your company unique?

CF: We’re run by clinicians, for clinicians.

Our corporate officers have actually run wound centers and cared for patients.

We have changed dressings, performed documentation, and used management reports. Each aspect of Intellicure is designed to maximize staff efficiency. For example, Intellicure EHR functions like a paper chart that moves seamlessly from field to field, not as a series of forms you must repeatedly “submit.” Intellicure is unique because we designed our documentation type commands. The use of these menus helps drive our unique interactive reporting features.

Compliance: We insist that we support compliance with billing and coding rules.

There are some “features” we don’t allow because they breach standards for medical records or billing compliance. Intellicure is designed from the perspective of the advanced practitioner and meets those medical and legal requirements, locking and securing signed documents against subsequent alteration.We follow HIMSS standards for all our medical record documentation and storage policies.

Commitment: Through our support of the US Wound Registry, a nonprofit foundation that houses de-identified EHR data, we provide benchmarking services and validation of quality measures, just as we previously validated facility billing with our acuity-scoring tool.

TWC: How do you ensure proper training on products and services?

CF:We provide a training program designed to assist clinicians at each step of EHR adoption and implementation.We begin weeks prior to “go-live” with your clinic manager coming to our office for three days of intensive orientation.This is followed by three days of onsite training with all staff. After “go-live,” charts are audited remotely for completeness and trainers provide feedback to clinicians for eight weeks regarding their documentation quality and to answer any questions.

Educational videos covering documentation issues, quality measures, meaningful use, and other topics are available on the popular “member’s portal.”

May 2012 Today’s Wound Clinic®

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TWC: What are your future goals?

CF: Our suite of software is set up to meet the needs of growing wound care clinics. We continue to diversify our services to assist clinicians with durable medical equipment ordering, billing compliance, and medical quality assurance, including quality measures and registry reporting upon which future reimbursement will be based.

TWC: How are you approaching challenges in wound care?

CF: Outpatient “fee for service,” as we know it, is going to end soon. Payment for wound care and other areas will be linked to performance. We are leading the way in helping to navigate this change. Because Intellicure’s programming internally audits the chart, it accurately calculates charges and determines resource utilization. We have incorporated evidence-based decision support logic within our EHR for all major wound diagnoses to drive quality of care. Our reporting capabilities enable stakeholders to find missed opportunities in delivering quality care and to understand physician and staff quality metrics.We are engaged in the development and testing of wound care quality measures upon which future reimbursement models will be based, and we offer the only wound care specific EHR that is a CMS-recognized registry for the physician quality reporting system upon which a percentage of Medicare payments will be based.

TWC: What’s new in 2012?

CF: RevenueTrak™: Improve the bottom line of your healthcare practice with the new, automated revenue cycle management software. Our claims-scrubbing features with continuously updating rules engine will help save money.

WoundSnap™: Our new, secure photograph transport system allows pictures to be transported from your smartphone camera to the patient chart.This feature is EHR integrated and HIPAA compliant.

TWC: How can clinicians contact you?

CF: Call our sales team at 800-6037896 or email sales@intellicure.com. n

www.todayswoundclinic.com

5/4/12 3:11 PM

NAVIGATING YOUR BUSINESS INTO SAFE WATERS

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Intellicure

*surescripts network accessed through the use of DrFirst Rcopia

Intellicure_0512.indd 1

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Potential Payment May Now Be Available for Every Application As of January 1, 2012, the Centers for Medicare and Medicaid Services (CMS) is eliminating the physician 90-day global surgical period for skin and dermal substitute procedures.

For more information, please visit the News page on the Healthpoint Biotherapeutics website at www.healthpointbio.com/news.

Call our Reimbursement Navigation Hotline at 1-877-805-5005 for more information.

Š2012 Healthpoint Biotherapeutics Healthpoint is a registered trademark of Healthpoint, Ltd. TM1302-0112

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clinician’sreport Negative Pressure Wound Therapy Univers 57 Condensed

Devon Medical Products • King of Prussia, PA Founded: 2005 • www.devonmedicalproducts.com info@devonmedicalproducts.com • (866) 446-0092 1) H ow many different NPWT products does your company produce? We currently produce one NPWT product, the extriCARE™ 2400 Negative Pressure Wound Therapy Device.

2) W hat is your most popular NPWT product? The extriCARE 2400 NPWT Device.

3) W hat is the suction pressure of your machine or the range of pressure the machine achieves? Between 60 and 140 mmHg in intervals of 20 mmHg. 4) I s the pressure pre-set? It has a factory default of 120 mmHg. an this be changed? Yes, it can be set at 60, 80, 100, 5) C 120, or 140 mmHg. 6) Is there an intermittent feature? Yes. 7) I s there a cutoff that stops suction if the canister is full? Yes. 8) I s there a one-way valve to prevent fluid from coming back through the tubing toward the patient? No. 9) H ow long does the battery last? 24 hours in “continuous” mode.

10) How much does the machine weigh? 8.6 ounces.

11) What is the interface with the wound? PU film bandages.

12) H ow often do you recommend changing the dressing? Every 2-3 days. an you “Y” wounds together? If so, how many? Yes, 13) C typically we don’t recommend any more than 2 sites be-

38

ing wound together. Note: The pressure burden with 2 wound sites Y-connected together will be heavier than 1 site alone. This means the intended treatment pressure at each of the Y-connected wound sites will be much lower than the screen display pressure.

14) H ow do you handle undermining? The undermining wound should be packed using material such as gauze before applying the extriCARE 2400 NPWT Device.

15) H ow often do you handle fistulas? The extriCARE 2400 NPWT Device is contraindicated for non-enteric and unexplored fistulas. However, enteric fistulas can be treated using the system with special attention from the attending clinicians.

16) H ow do you handle exposed tendon or bone? Precautionary measures should be taken if any tendon or bones are exposed. Additionally, sharp bone edges require special attention by being covered and smoothed wherever possible.

17) D o you have any special recommendations for high bioburden or infection? High bioburden or infection should be treated with antibiotics or equivalent measures before initiating the NPWT therapy. Infected wounds treated using the extriCARE 2400 NPWT Device should be monitored closely, and bandages should be changed more frequently. Additionally, to reduce the risk of transmission of infectious agents, universal precautions should be taken when handling or working with therapeutic parts or equipment. ow is your device billed? (Is the machine rented?

18) H How are supplies obtained?) The extriCARE 2400 NPWT Device is sold directly to the facility or DME. Inventory is held in King of Prussia, PA.

May 2012 Today’s Wound Clinic®

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www.todayswoundclinic.com

5/4/12 3:03 PM

Visit Us in Booth #1715 Innovation in Medical Products Engineering

Educating with Ideas Tomorrow The Latest in Negative Pressure Wound Treatment WOCNfor Society’s 44 Annual Conference ®

Introducing the extriCARETM 2400 NPWT System

th

Wound, Ostomy and Continence Nurses Society™

CHARLOTTE, NORTH CAROLINA • JUNE 9-13, 2012

Product Features: •

Easy & Quick Application: Wound preparation time is approximately 15 minutes.

•

Lightweight & Portable: Pump only weighs 8.6 ounces. Carrying pouch included, promoting an active wound healing lifestyle.

•

Anatomically Fitted Bandages: Create tighter seals for various parts of the body.

•

Rechargeable Battery: 24 hours of continuous battery life. Battery is rechargeable.

Evacuation Tube extriCARE 2400TM Pump Tube Clamp

Pump & Pressure Control

Collection Canister

Anatomically Fitted Bandage

Devon Medical Products, a global medical device designer, manufacturer, and distributor of compression therapy pumps and other wound related products, has released an innovative new NPWT device.

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clinician’sreport Kinetic Concepts Inc. (KCI) • San Antonio, Texas Founded: 1976 • www.kci1.com media@kci1.com • (800) 275-4524 1) How many different NPWT products does your company produce? KCI manufactures and sells six NPWT products: ActiV.A.C.® Therapy System, InfoV.A.C.® Therapy System, V.A.C. Instill® Wound Therapy, V.A.C.® Freedom Therapy System, V.A.C.Via™ Therapy System, and, most recently, V.A.C.Ulta™ Therapy System.

Other KCI devices within its Negative Pressure Technology portfolio include the Prevena™ Incision Management System and the ABThera™ Open Abdomen Negative Pressure Therapy System. For a list of published clinical evidence for our products, visit www.kci1.com/kci1/ clinicalevidence.

2) What is your most popular NPWT product? The ActiV.A.C. Therapy System.

3) What is the suction pressure of your machine or the range of pressure the machine achieves? The pressure provided by the ActiV.A.C. Therapy System is preset to -125 mmHg. This default setting is within the V.A.C. Therapy Clinical Guidelines’ recommended range for most wounds. The user-selectable negative pressure range is between -25 and -200 mmHg, with the pressure-setting selection being left to physician discretion.

4) Is the pressure pre-set? The pressure provided by the ActiV.A.C. Therapy System is preset to -125 mmHg and continuous therapy.

5) Can this be changed? Yes, the level of therapeutic negative pressure for all KCI NPWT units can be changed by using the control panel on the therapy unit. Settings are adjustable based on individual patient clinical needs and circumstances.

6) Is there an intermittent feature? Yes, all KCI NPWT units, including the ActiV.A.C. Therapy System, offer continuous and intermittent negative pressure therapy applications.

7) Is there a cutoff that stops suction if the canister is full? All of our NPWT units contain electronic sensors that stop the pump when the canister is full.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? No, however, there are safety features that mitigate retrograde flow toward the patient. Our proprietary SensaT.R.A.C.™ Tubing used in conjunction with V.A.C. Therapy has 40

clamps at both the patient and canister side to prevent this fluid transfer. Additionally, canisters are available with a gel pack that helps to solidify wound exudate.

9) How long does the battery last? The ActiV.A.C. Therapy System’s battery lasts for 14 hours, on average, when fully charged.

10) How much does the machine weigh? (How portable is it?) The ActiV.A.C. Therapy System is fully portable and only weighs 2.4 lbs when the 300 ml canister is empty. The recently launched V.A.C.Via Therapy System is specifically designed for mobility and weighs only 0.7 lbs with a 250 ml canister.

11) What is the interface with the wound? KCI offers a variety of wound dressings: V.A.C. GranuFoam™ Dressing, V.A.C. GranuFoam Silver® Dressing, V.A.C. WhiteFoam Dressing, V.A.C. Simplace™ Dressing, and V.A.C. GranuFoam Bridge Dressing. Additional V.A.C. GranuFoam Specialty Dressings are also available.

The V.A.C. GranuFoam Dressing is placed directly at the wound site to facilitate negative pressure application. The unique pore structure of V.A.C. GranuFoam Dressings helps promote healing and tissue granulation.

Each tiny pore is intended to deliver mechanisms critical to wound healing. The V.A.C. GranuFoam Dressing adapts to the contours of deep and irregularly shaped wounds, helps provide uniform distribution of negative pressure at the wound site, helps facilitate exudate and removal of infectious material through a hydrophobic pore structure, compresses to less than half its size under negative pressure to help draw wound edges together, and induces macrostrain and microstrain.

12) How often do you recommend changing the dressing? Current device labeling recommends the following: a) Wounds being treated with V.A.C. Therapy should be monitored on a regular basis. b) In a monitored, non-infected wound, V.A.C. Dressings should be changed every 48-72 hours, but no fewer than 3 times per week, with frequency adjusted by the clinician as appropriate. c) Infected wounds must be monitored often and very closely. For these wounds, the dressing change intervals should be based on a continuing evaluation of wound condition and the patient’s clinical presentation, rather than a fixed schedule. d) Dressings may need to be changed more often than 48-72 hours.

May 2012 Today’s Wound Clinic®

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clinician’sreport 13) Can you “Y” wounds together? If so, how many? Yes, the ActiV.A.C. Therapy System can be used to “Y” 2 wounds together if they are of the same etiology. By applying a Y-connector to the canister tubing, 1 V.A.C. Therapy unit may be used to simultaneously treat multiple wounds on the same patient.

14) H ow do you handle undermining? KCI V.A.C. WhiteFoam Dressing may be placed in undermined areas with good foam-to-tissue contact. When using the V.A.C. WhiteFoam Dressing, the minimum pressure setting is -125 mmHg. 15) H ow often do you handle fistulas? V.A.C. Therapy is contraindicated for use with non-enteric and unexplored fistulas. If considering the use of V.A.C. Therapy involving enteric fistula, it’s recommended to seek support from an expert clinician. V.A.C. Therapy is not recommended or designed for fistula effluent management or containment, but as an aid to wound healing in and around the fistula.

16) H ow do you handle exposed tendon or bone? Tendons, ligaments, and nerves should be protected to avoid direct contact with V.A.C. Dressings and can be covered with natural tissue or meshed, non-adherent

porous material or bioengineered tissue to help minimize risk of desiccation or injury. Bone may be protected with a single layer of a non-adherent interface.

17) D o you have any special recommendations for high bioburden or infection? V.A.C. Therapy is contraindicated for untreated osteomyelitis. If clinicians decide to use V.A.C. Therapy for other infected wounds, they must be monitored often and very closely, and dressings may need to be changed more often than 48-72 hours in order to assess the wound and patient condition. The dressing change intervals should be based on a continuing evaluation of wound condition and the patient’s clinical presentation, rather than a fixed schedule.

18) How is your device billed? (Is the machine rented?

How are supplies obtained?) The ActiV.A.C. Therapy System and V.A.C. Freedom Therapy Systems are rented and typically billed to the patient’s insurance, depending on eligibility and coverage. Dressings are available for purchase and supplies are replenished, as needed, based on clinical evaluation by healthcare professionals.

For proper use of KCI NPWT products, please refer to the V.A.C.Therapy Clinical Guidelines, A Reference Source for Clinicians, and device labeling.

Medela Inc. • McHenry, IL • Founded: 1961 www.medela.com • suction@medela.com • (877) 694-6842 1) How many different NPWT products does your company produce? We offer a complete NPWT portfolio, including pumps, wound care kits, and accessories.

11) What is the interface with the wound? Wound contact layer, foam, or gauze.

2) W hat is your most popular NPWT product? Invia Liberty.

12) How often do you recommend changing the dressing?

We recommend 2-3 times weekly.

3) What is the suction pressure of your machine or the range of pressure the machine achieves? 60 mmHg-200 mmHg.

13) Can you “Y” wounds together? If so, how many? Yes, at least 4 or at clinician discretion.

4) Is the pressure pre-set? Yes.

14) How do you handle undermining? 15F Channel drain is specifically designed for this purpose.

5) Can this be changed? Yes. 6) Is there an intermittent feature? Yes. 7) Is there a cutoff that stops suction if the canister is full?

There’s an initial warning 30 min prior, with auto shutoff.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? Yes.

How often do you handle fistulas? Enteric and ex15) plored fistulas may be managed with the 15F Channel drain specifically designed for this purpose.

16) How do you handle exposed tendon or bone? With precaution and covering all fragile structures with wound contact layer.

9) H ow long does the battery last? Up to 14 hours.

17) D o you have any special recommendations for high bioburden or infection? Our customary kits

10) H ow much does the machine weigh? 2.2 lbs.

contain antimicrobial gauze specifically designed for this purpose.

www.todayswoundclinic.com

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May 2012 41

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clinician’sreport 18) How is your device billed? (Is the machine rented? How are supplies obtained?) The devices may be obtained through rental or purchase. Both devices and kits are reimbursed through Medicare Part B and commercial payers.

Smith & Nephew • St. Petersburg, FL Founded: 1856 • www.myrenasys.com www.possiblewithpico.com • (800) 876-1261 1) How many different NPWT products does your company produce? We produce more than 25 NPWT products, including the pocket-sized PICO™ system, a singleuse NPWT system; the RENASYS™ GO and RENASYS EZ Plus devices; RENASYS-F Foam and RENASYS-G Gauze Dressing kits; RENASYS-AB Abdominal Dressing Kit; RENASYS High Output Kit; RENASYS Channel Drain Kit; 800 mL, 300 mL, and 250 mL canisters; Transparent Films, Y-connectors; and other NPWT accessories. The RENASYS EZ Plus and RENASYS GO are available with RENASYS Soft Port, which enables NPWT to be delivered directly at the wound site without sacrificing patient comfort or safety and reducing the need for bridging.

2) What is your most popular NPWT product? In the home care market, the RENASYS GO device is our most popular product. It is effective and user-friendly. The pump is lightweight (2.4 lbs), quiet, and can be used with either a 300 mL or 800 mL canister, enhancing mobility for home care and acute care use. The acute care market favors RENASYS EZ Plus for its robust, easy-to-use solution for high-volume output wounds with the flexibility to treat a variety of acute and chronic wounds. Our recently introduced PICO system is also gaining in popularity, due to its canister-free small size and overall simplicity.

3) What is the suction pressure of your machine or the range of pressure that the machine achieves? RENASYS GO: 40 mmHg-200 mmHg; RENASYS EZ PLUS: 40 mmHg-200 mmHg; PICO: operates at continuous negative pressure of nominally 80 mmHg.

4) Is the pressure pre-set? Not on the RENASYS EZ Plus or the RENASYS GO. The pressure is pre-set on the PICO system, and it operates at continuous negative pressure of nominally 80 mmHg. 5) Can it be changed? The pressure setting on the RENASYS devices can be changed. With both pumps, the pressure can be set at different levels. The device resumes at the same level of pressure as was set when

42

it was last turned off or set to “standby.” The pressure cannot be changed on the PICO system.

6) Is there an intermittent feature? The RENASYS devices have an intermittent feature. The PICO system does not.

7) Is there a cutoff that stops suction if the canister is full?

The RENASYS canisters are protected by a filter. An audible alarm will sound and a visual light flashes when the canister is full, but the devices do not turn off. The PICO system is canister-free.

8) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? The RENASYS and PICO systems have a filter that prevents fluid from coming back through the tubing toward the patient.

9) How long does the battery last? RENASYS GO: 20 hours; RENASYS EZ Plus: 40 hours. The PICO system runs on 2 AA batteries that can be changed if required but should not be necessary. It is indicated for use up to 7 days, at which time the system is disposable.

10) How much does the machine weigh? (How portable is it?) RENASYS GO is 2.4 lbs and comes with a shoulder strap and carry bag. RENASYS EZ Plus is 7.4 lbs and can be mounted on an IV pole and bed rail attachments.

PICO is less than 4.2 oz and is small enough to easily fit in a pocket.

11) What is the interface with the wound? For the RENASYS systems, the wound interfaces with foam or gauze devices. The PICO system employs a revolutionary dressing technology that manages exudate, eliminates the need for canisters, and interfaces with the wound.

12) How often do you recommend changing the dressing? We recommend changing foam dressings every 48 hours and changing AMD gauze dressings every 48-72 hours. The PICO system may be left in place for up to 7 days, depending on the level of exudate.

May 2012 Today’s Wound Clinic®

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www.todayswoundclinic.com

5/4/12 3:06 PM

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2012 brings many new reimbursement and payment policy changes for wound care, HBOT departments and physicians. Even if you have attended a Wound Clinic Business meeting in previous years, you won’t want to miss this entirely new 2012 program, which highlights all the changes you must implement.

• Investigate your REVENUE CYCLE TEAM’S knowledge of the ideal operational processes by following a patient through initial access/registration, assessment with management documentation requirements, charge capture and diagnosis and, finally, claim submission and payment. Then further your team’s knowledge of why and how to conduct internal audits pertaining to wound care and HBOT. • Which REVENUE CYCLE TEAM MEMBERS should attend? Medical directors, physicians and podiatrists, non-physician practitioners, program directors, clinical managers, therapists, billing directors, charge description master directors, HIM directors, coders, office managers, corporate compliance officers, revenue integrity auditors, and hospital executives.

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WCB_HouseAd.indd 1

3/22/12 4:41 PM

clinician’sreport 13) Can you “Y” wounds together? If so, how many? We recommend Y-connecting a maximum of 2 wounds with the RENASYS devices. PICO dressings do not Y-connect.

14) How do you handle undermining? The RENASYS Foam and Gauze kits are both indicated for undermining. We also recommend use of the channel drain kit with moistened AMD gauze or the RENASYS-G Kit for its ability to conform to these types of wounds. The PICO system can be used to handle undermining in wounds with the addition of either a foam or a gauze filler.

15) H ow do you handle fistulas? We offer the RENASYS High Output Kit, which includes a large 28fr round irrigation aspiration drain. This kit is indicated for explored fistulas.

16) How do you handle exposed tendon or bone? For the RENASYS systems, we offer a non-adherent gauze in our gauze kits and recommend the use of a non-adher-

ent layer to use with the foam interface to protect exposed tendon or bone while it is under NPWT. 17) Do you have any special recommendations for high bioburden or infection? We recommend the use of Smith & Nephew ACTICOAT Flex as a wound contact layer for wounds with a high bioburden or infection.

ACTICOAT Flex is compatible for use with NPWT with gauze or foam interface materials. ACTICOAT may also be used with PICO. 18) How is your device billed? (Is the machine rented?

How are supplies obtained?) Our RENASYS pumps are rented. Dressing kits, canisters, and other services are supplied through our partners: Universal Hospital Services, which supports acute care and long-term care, and Apria Healthcare, which supports home care. Our partners perform third-party billing, and all biomed operation on the pumps to ensure quality pumps are delivered.

The PICO system is available off-the-shelf, direct from Smith & Nephew.

Spiracur Inc. • Sunnyvale, CA • Founded: 2007 www.spiracur.com • info@spiracur.com • (877) 774-7228 mmHg, and 75 mmHg pressure settings.

1) What is the name of your featured product? SNaP® Wound Care System.

2) Does your product operate without electricity or batteries? Yes, the SNaP System uses a proprietary spring mechanism to generate consistent, even levels of pressure.

3) Does your product operate silently? Yes, it requires no noisy motors, electronics, or batteries to interfere with daily living.

4) Is your product portable? Yes, it is a pocket-sized device that can be worn discreetly under clothing.

5) How much does your product weigh? 2.2 oz.

6) Does your product include an advanced wound dressing? Yes, it has a proprietary hydrocolloid dressing which may reduce periwound maceration.

7) Does your contact layer have antimicrobial properties?

Yes, the SNaP System provides a choice of blue foam or antimicrobial gauze. The gauze contains 0.2% polyhexamethylene biguanide.

8) What levels of negative pressure does your product deliver? The SNaP System is available in 125 mmHg, 100

44

9) Is there a cutoff that stops suction if the canister is full?

Yes. 10) Is there a one-way valve to prevent fluid from coming back through the tubing toward the patient? Yes. 11) Can you “Y” wounds together? If so, how many? Yes, 2.

12) How often do you recommend changing the dressing?

The SNaP System requires 2 dressing changes per week.

13) Is your system quicker to apply than a powered NPWT device? Yes, the SNaP System takes about half the time to apply than a powered NPWT device.

14) Have you conducted any clinical studies with your product? Yes, we have completed a 132-patient comparative, randomized-controlled study demonstrating non-inferiority to powered NPWT in wound healing outcomes. In addition, patient survey data found improved quality of life in areas such as overall mobility, social interaction, and sleep.

15) I s your product available off-the-shelf? Yes, the off-the-shelf availability eliminates the rental procurement process.

May 2012 Today’s Wound Clinic®

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®

www.todayswoundclinic.com

5/4/12 3:05 PM

Say hello to SNaP.

®

My partner in healing.

The SNaP® Wound Care System combines the portability of advanced wound dressings with the proven efficacy of negative pressure therapy in a discreet design that won’t get noticed.  Small,

silent, lightweight design disappears under clothes

 Demonstrated

non-inferiority in wound healing outcomes for patients completing at least 4 weeks of therapy1

 The

SNaP ® System interferes significantly less with overall activity, sleep and social interactions than the V.A.C.® System1

www.spiracur.com

Active healing that’s out of sight.

Spiracur Inc. 1180 Bordeaux Drive Sunnyvale, CA 94089 Toll Free 1.877.774.7228 1. Armstrong, D. G., W. A. Marston, et al. “Comparison of Negative Pressure Wound Therapy with the SNaP® Wound Care System vs. V.A.C.® Therapy System for the Treatment of Chronic Lower Extremity Ulcers: A Multicenter Randomized Controlled Trial.” Wound Rep Reg 2011; 19; 173-180.

Spiracur, SNaP and SNaP & Design are registered trademarks of Spiracur Inc. The SNaP® Wound Care System is protected by one or more U.S.patents, with other U.S. and certain foreign patents pending. ©2012 Spiracur Inc. All rights reserved.

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TWCnewsupdate Spiracur Launches NPWT Website Spiracur Inc., Sunnyvale,CA,recently released an enhanced website featuring patient-friendly animation to help demonstrate the benefits of its SNaP® Wound Care System for treatment of chronic and acute wounds.

According to company officials, the site is navigation-friendly and presents information about Spiracur’s negative pressure wound therapy (NPWT) solution through training videos, personal patient success stories, clinical data, application guidelines for patients and caregivers, and an animation short movie.

“We’re excited to launch our newly designed website featuring an easyflow format and the latest in animation technology,” said Linda LaMagna, vice president of global marketing and strategic planning at Spiracur. “The website enables patients and clinicians alike to easily find information they’re looking for with regard to the SNaP System and wound healing solutions. It is our primary goal to make a positive difference in a patient’s quality of life throughout the wound healing process.”

The four-minute animated short tells the story of Charlie, a 71-year-old war veteran who lives with diabetes. n

SAWC Spotlight: ConvaTec Donates $10K To AAWC Wellness Walk Officials at ConvaTec,a global developer and marketer of medical technologies for community and hospital care based in Skillman, NJ, have announced a $10,000 donation to the Association for the Advancement of Wound Care’s (AAWC) “GlobalVolunteers” program through the SAWC Walk for Wellness that took place at the 25th Annual Symposium on Advanced Wound Care and Wound Healing Society (SAWC/WHS) in Atlanta April 19-22.

Conference participants were provided with pedometers that counted each step they took during the conference to raise money for AAWC.They were also encouraged to engage in physical activity while connecting with other wound care professionals. At the end of each day, participants logged the number of steps they walked and could monitor their personal standing.

According to officials, the Walk for Wellness helped raise awareness of the AAWC volunteer program and the need for ongoing education and training programs to promote access to proper wound treatment for the underserved in developing countries and North America.

“For the second year in a row, ConvaTec is supporting the important work of the AAWC GlobalVolunteers through the efforts of so many clinicians and nurses who joined in the SAWCWalk for Wellness fundraising effort,” said Terry Treadwell, MD, FACS, AAWC past president. “These funds will help us to continue to provide professional education programs in the areas of the world where they are most needed.”

AAWC GlobalVolunteers is an initiative supported by the volunteer leadership of AAWC members, in partnership with Health

Volunteers Overseas, that seeks to bring the science of wound care to the underserved in developing countries and North America.

“We are very pleased that so many of the men and women who attended SAWC/WHS participated in theWalk forWellness again this year to help raise money to support the AAWC Global Alliance,” said Brad Barton, president of ConvaTec US.“The AAWC Global Volunteers program plays a vital role in expanding access to education and training for local healthcare professionals.

We are honored to be able to support their work once again this year.” n

Wound Care Center Names New Medical Director John Glenn, MD, has been appointed medical director of the Bayhealth Wound Care Center, Dover, DE. Glenn is board certified in thoracic and vascular surgery and has nearly four decades of medical experience,according to Bayhealth Wound Care Center officials.

Glenn also serves with Eden Hill Medical Surgical Group and is medical director of the ICU at Bayhealth–Kent General Hospital, both of which are also located in Dover.

In his new position,Glenn will oversee the wound care center. n

IN THE KNOW: A recent Gallup poll has found that 29% of American adults are willing to travel outside the US to receive medical treatment.

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TWCnewsupdate Wound Healing Center Earns National Recognition Carondelet St. Mary’s Wound Healing Center, Tucson, AZ, is being recognized by the National Healing Corp.

(NHC) for maximizing its resources to meet the growing needs of its community.

Part of a nationwide network of researchers and specialists reporting patient outcomes to the NHC, now Healogics Inc., reportedly the nation’s largest provider of managed and outsourced wound healing centers, St. Mary’s offers advanced treatments including hyperbarics, negative pressure wound

therapy, bio-engineered skin substitutes, biological and biosynthetic dressings, and growth-factor therapies, officials said.

“Our patients have benefited from the extensive data and information available to the wound healing center physicians and nurses,” said Jennifer Biggs, RN, senior director of nursing at St. Mary’s.

Headquartered in Jacksonville, FL, the NHC manages more than 500 wound care centers in more than 10 percent of the hospitals in the US. n

PRESCRIPTION POINTER: FDA Issues Warning for Diabetics FDA officials are alerting healthcare professionals of a possible risk when using blood pressure medications containing aliskiren with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients living with diabetes or renal impairment.

According to the FDA, these drug combinations should not be used in patients with diabetes.Additionally, the FDA urges clinicians to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (ie, where glomerular filtration rate is < 60 mL/min). Labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial,“Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints,” officials said. Clinicians are advised to review drug safety information at www. fda.gov/drugs/drugsafety/ucm300889.htm. Healthcare professionals are also encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda. gov/medwatch/report.htm n

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Carolina Wound Center Earns Another Award Scotland Wound Healing Center, Laurinburg, NC, has been named the winner of the Front Runners Award by Healogics Inc. (Jacksonville, FL), formerly National Healing Corp. It’s the second consecutive year that Scotland has earned the honor, which recognizes proactive initiatives in healthcare.

Dana Peiko, area vice president with Healogics, recently presented staff at Scotland with a plaque to commemorate the award. In 2010, the center was recognized as the New Center of the Year by the National Healing Corp., giving the facility an award from the organization in each of the three years that it’s been providing care.

“This is a testament to the excellent care you provide here, and we at Healogics congratulate you on receiving this honor,” Peiko said during the award ceremony.

Likely candidates for treatment at Scotland Wound Healing Center are those suffering from diabetic or pressure ulcers, infections, compromised skin grafts and flaps, and wounds that haven’t healed within 30 days, according to officials. Brian Parkes, MD, medical director, said, “The community has been very supportive of the center. Some patients, upon completing treatment, have shared their success story with us and become a part of Scotland Health Care System’s ‘Believer’ marketing campaign.” n

IN THE KNOW: According to the Pew Research Center, only 15% of Americans believe the nation’s healthcare system is the “best in the world.”

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Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling.

Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure.

Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf.

DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers.

Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice.

How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8 References: 1. Veves A, Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295. 2. Data on file, Organogenesis Inc. 3. Apligraf® [package insert]. Canton, MA: Organogenesis Inc; 2010.

Please see complete prescribing information at www.Apligraf.com © 2011 Organogenesis Inc. All rights reserved. Printed in U.S.A. 01/11 Apligraf is a registered trademark of Novartis.

Advertiser’s Index Celleration ���������������������������������������������������������������������������������������������������������������������������������������������������������� 11 Devon Medical Products ������������������������������������������������������������������������������������������������������������������������������������ 39 Eloquest Healthcare ������������������������������������������������������������������������������������������������������������������������������������������� 15 Healthpoint Biotherapeutics ������������������������������������������������������������������������������������������������������������������������������� 37 Intellicure Inc. ���������������������������������������������������������������������������������������������������������������������������������������������������� 35 KCI........................................................................................................................................................................ 7 Medela Inc ������������������������������������������������������������������������������������������������������������������������������������������������������������ 3 Net Health Systems ������������������������������������������������������������������������������������������������������������������������������������ Cover 3 Organogenesis Inc. ������������������������������������������������������������������������������������������������������������������������������48, Cover 4 Organogenesis_PI_0211.indd 1

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PuriCore �������������������������������������������������������������������������������������������������������������������������������������������������������������� 19 Sechrist Industries Inc. �������������������������������������������������������������������������������������������������������������������������������Cover 2 Spiracur ��������������������������������������������������������������������������������������������������������������������������������������������������������������� 45 Well Care Strategies �������������������������������������������������������������������������������������������������������������������������������������������� 5

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New Ideas for Your Paper.

Don’t leave the complexities of wound care management to chance . Whether preparing for a Joint Commission visit, ordering patient supplies, or reporting on this month’s financials, the WoundExpert software makes it all possible. And, as a Certified system, the integrated clinical, financial, and regulatory tools allow you to track outcomes and enhance patient care.

WoundExpert.com © 2012 Net Health Systems, Inc. WoundExpert is a Registered Trademark of Net Health Systems, Inc.

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After 4 weeks of failed conventional therapy— Rethink the Wound. Think Apligraf®.

Healing Wounds.

Healing Lives.

Act now for fast and complete healing of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).1-3 • Choose the ONLY bioengineered, bilayered, living cell–based product3 • Apligraf is the ONLY treatment indicated for both DFUs and VLUs3 • FDA approval for DFUs as early as 3 weeks3 • FDA approval for VLUs as early as 4 weeks3 • Frequent reassessment and reapplication of Apligraf as needed can significantly improve the speed of healing and incidence of complete wound closure in DFUs and VLUs1-3

For information on support programs and tools available from Organogenesis Inc., call 1.888.HEAL.2.DAY (1.888.432.5232—Option 3) Please see accompanying essential prescribing information, or visit www.Apligraf.com for complete prescribing information

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