EWMA Journal October 2010 by EWMA European Wound Management Association

WOUND CLOSURE, DEFINED AS TOTAL EPITHELIALISATION WITHOUT DISCHARGE, IS THE MOST IMPORTAN ENDPOINT RELATING TO ULCER HEALING. IT MUST BE CONFIRMED BY AN INDEPENDENT SOURCE (PHOTO RAPHY) AND THERE MUST BE SUFFICIENT FOLLOW-UP TO CONFIRM HEALING. WOUND AREA REDUCTION IS VALID ENDPOINT WITH REGARD TO WOUND HEALING BUT IT MUST BE CONFIRMED BY TRACING AND INCLUD A PREDEFINED RELEVANT CUT-OFF TO ENSURE THAT ‘REDUCTION RATE ERROR’ DOES Volume NOT OCCUR. THERE 10 Number 3 ENOUGH EVIDENCE TO SUPPORT THE USE OF A 50% REDUCTION IN WOUND SURFACE AREA OVER TIME AS October 2010 USEFUL OUTCOME, PROVIDED THAT THE INITIAL WOUND SIZE AND THE MEASUREMENT TECHNIQUE ARE TAKE Published by INTO CONSIDERATION. THE TIME INTERVAL USED IN SUCH ASSESSMENT WILL VARY DEPENDING ON THE WOUN European TYPE. ANY REDUCTION OF LESS THAN 50% CANNOT BE SUPPORTED BY THE CURRENT Wound LITERATURE; IN THE Management IS AN IMPORTAN INSTANCES, MORE OBJECTIVE MEASURES OF SIZE REDUCTION MUST BE USED. TIME TO HEAL Association OUTCOME. HOWEVER, THE STUDY PROTOCOL MUST CONSIDER THE SUBSTANTIAL METHODOLOGICAL DIFFICU TIES ENTAILED, PARTICULARLY CONFIRMATION OF THE EXACT DATE OF HEALING FOR EACH PATIENT DURIN THE SPECIFIED OBSERVATION PERIOD. TO DATE, THE ACCEPTED TIME INTERVAL FOR RESOURCE STUDIES IS ON YEAR. THERE IS AN URGENT NEED FOR A VALIDATED SCORING SYSTEM WITH REGARD TO WOUND CONDITIO WHEN USING CHANGES IN THE WOUND CONDITION AS AN OUTCOME PARAMETER, THEY MUST BE PREDEFINE AND MEASURED IN SUCH A WAY THAT THEY CAN BE VALIDATED INDEPENDENTLY, WHEREVER POSSIBLE (FO INSTANCE, BY PHOTOGRAPH). WHEN USING BIOLOGICAL MARKERS AS A PRIMARY OUTCOME, THEY SHOULD B CLEARLY PREDEFINED, AND A CLINICALLY RELEVANT UNIT OF CHANGE SHOULD BE SPECIFIED; RELIABLE AN VALID QUANTITATIVE ASSESSMENT METHODS SHOULD BE USED. WHEN USING WOUND INFECTION AS A PR MARY OUTCOME MARKER, IT SHOULD BE CLEARLY PREDEFINED. AT PRESENT, THIS COULD BE EITHER A BINAR MEASURE OF PRESENCE/ABSENCE OR A COMPOSITE SCORE FOCUSING ON CLINICAL SIGNS AND SYMPTOM REGARDLESS OF THE ASSESSMENT TOOL USED, WHEN USING PAIN AS AN OUTCOME MEASURE IT IS IMPORTAN TO PRE-DEFINE THE AMOUNT OF WOUND PAIN REDUCTION THAT IS CLINICALLY IMPORTANT. WHEN SURR GATE PARAMETERS SUCH AS SYMPTOMS AND SIGNS, OR COMPOSITE ENDPOINTS SUCH AS SCALES, ARE USED A PRIMARY ENDPOINTS, IT IS ESSENTIAL THAT BOTH THEIR BASIC DEFINITION AND WHAT IS CONSIDERED TO B A CLINICALLY RELEVANT DIFFERENCE ARE PREDEFINED. WHEN USED AS AN PRIMARY ENDPOINT, IT IS FAVOU ABLE FOR IT TO BE VERIFIED BY AN INDEPENDENT EVALUATOR. WHEN ASSESSING DRESSING PERFORMANC IN AN OBJECTIVE MANNER, WITH A FOCUS ON A SPECIFIC ASPECT OF SYMPTOM MANAGEMENT, A COMPAR TIVE STUDY MAY NOT BE NEEDED; THE RELEVANT DATA COULD BE BETTER ASSESSED USING A COHORT STUD WITH A STANDARDISED, REPRODUCIBLE AND VALIDATED PROTOCOL THAT INCLUDES RESOURCE UTILISATIO (WHEN APPROPRIATE). HRQOL ASSESSMENTS MUST BE BASED ON TOOLS WITH ESTABLISHED PSYCHOMETRIC THE TYPE OF ASSESSMENT MUST FIT WITH THE PURPOSE OF THE DATA COLLECTION: IF HRQOL DATA ARE T BE USED FOR HEALTH TECHNOLOGY ASSESSMENT REVIEWS, THEN GENERIC AND/OR UTILITY METHODS MUS BE INCLUDED. WHEN COST IS USED AS AN OUTCOME PARAMETER IN WOUND MANAGEMENT, IT IS ESSENTIA TO MEASURE ALL THE QUANTITIES OF RESOURCES USED AND THEN ADD THE VALUE OF THOSE RESOURCE ACCORDING TO A PREDEFINED PROTOCOL. IT IS RECOMMENDED THAT RESOURCE USE AND COST ARE SHOW SEPARATELY. WHEREVER RESOURCES HAVE ALTERNATIVE USES, DECISIONS ON THE ADOPTION OF NEW TEC NOLOGIES OR NEW PROCEDURES CANNOT BE MADE ON THE BASIS OF CLINICAL OUTCOMES ALONE. RATIONA CHOICE REQUIRES EVIDENCE OF THE COSTS AND BENEFITS OF ALTERNATIVES. IN ORDER TO MAXIMISE TH VALUE OF INVESTMENTS IN CLINICAL RESEARCH, STUDIES SHOULD BE DESIGNED TO ADDRESS THE RELATIV COST-EFFECTIVENESS OF ALTERNATIVES FROM THE OUTSET, AS WELL AS THEIR SAFETY AND EFFECTIVENES WOUND CLOSURE, DEFINED AS TOTAL EPITHELIALISATION WITHOUT DISCHARGE, IS THE MOST IMPORTAN ENDPOINT RELATING TO ULCER HEALING. IT MUST BE CONFIRMED BY AN INDEPENDENT SOURCE (PHOTO RAPHY) AND THERE MUST BE SUFFICIENT FOLLOW-UP TO CONFIRM HEALING. WOUND AREA REDUCTION IS VALID ENDPOINT WITH REGARD TO WOUND HEALING BUT IT MUST BE CONFIRMED BY TRACING AND INCLUD A PREDEFINED RELEVANT CUT-OFF TO ENSURE THAT ‘REDUCTION RATE ERROR’ DOES NOT OCCUR. THERE ENOUGH EVIDENCE TO SUPPORT THE USE OF A 50% REDUCTION IN WOUND SURFACE AREA OVER TIME AS USEFUL OUTCOME, PROVIDED THAT THE INITIAL WOUND SIZE AND THE MEASUREMENT TECHNIQUE ARE TAKE INTO CONSIDERATION. THE TIME INTERVAL USED IN SUCH ASSESSMENT WILL VARY DEPENDING ON THE WOUN TYPE. ANY REDUCTION OF LESS THAN 50% CANNOT BE SUPPORTED BY THE CURRENT LITERATURE; IN THE INSTANCES, MORE OBJECTIVE MEASURES OF SIZE REDUCTION MUST BE USED. TIME TO HEAL IS AN IMPORTAN OUTCOME. HOWEVER, THE STUDY PROTOCOL MUST CONSIDER THE SUBSTANTIAL METHODOLOGICAL DIFFICU TIES ENTAILED, PARTICULARLY CONFIRMATION OF THE EXACT DATE OF HEALING FOR EACH PATIENT DURIN THE SPECIFIED OBSERVATION PERIOD. TO DATE, THE ACCEPTED TIME INTERVAL FOR RESOURCE STUDIES IS ON YEAR. THERE IS AN URGENT NEED FOR A VALIDATED SCORING SYSTEM WITH REGARD TO WOUND CONDITIO WHEN USING CHANGES IN THE WOUND CONDITION AS AN OUTCOME PARAMETER, THEY MUST BE PREDEFINE AND MEASURED IN SUCH A WAY THAT THEY CAN BE VALIDATED INDEPENDENTLY, WHEREVER POSSIBLE (FO INSTANCE, BY PHOTOGRAPH). WHEN USING BIOLOGICAL MARKERS AS A PRIMARY OUTCOME, THEY SHOULD B

PATIENT OUTCOME

The EWMA Journal ISSN number: 1609-2759 Volume 10, No 3, October, 2010

EWMA Council

Electronic Supplement October 2010 www.ewma.org

Jan Apelqvist

Zena Moore

Marco Romanelli

President Elect

President

Immediate Past President

The Journal of the European Wound Management Association Published three times a year Editorial Board Carol Dealey, Editor Deborah Hofman, Editor Electronic Supplement Sue Bale Finn Gottrup Martin Koschnick Zena Moore Marco Romanelli Zbigniew Rybak José Verdú Soriano Rita Gaspar Videira Peter Vowden

Sue Bale

Patricia Price

Recorder

Paulo Alves

Secretary

Barbara E. den Boogert-Ruimschotel

EWMA Journal Editor

Carol Dealey

Corrado M. Durante

Luc Gryson

Dubravko Huljev

Gerrolt Jukema

Martin Koschnick

Severin Läuchli

Treasurer

EWMA web site www.ewma.org Editorial Office please contact: EWMA Secretariat Martensens Allé 8 1828 Frederiksberg C, Denmark. Tel: (+45) 7020 0305 Fax: (+45) 7020 0315 ewma@ewma.org

Eskild Winther Henneberg

Layout: Birgitte Clematide Printed by: Kailow Graphic A/S, Denmark Copies printed: 13,000 Prices: Distributed free of charge to members of the European Wound Management Association and members of co-operating associations. Individual subscription per issue: 7.50€ Libraries and institutions per issue: 25€ The next issue will be published in January 2011. Prospective material for publication must be with the editors as soon as possible and no later than 1 November 2010 The contents of articles and letters in EWMA Journal do not necessarily reflect the opinions of the Editors or the European WoundManagement Association. Copyright of all published material and illustrations is the property of the European Wound Management Association. However, provided prior written consent for their reproduction obtained from both the Author and EWMA via the Editorial Board of the Journal, and proper acknowledgement and printed, such permission will normally be readily granted. Requests to reproduce material should state where material is to be published, and, if it is abstracted, summarised, or abbreviated, then the proposed new text should be sent to the EWMA Journal Editor for final approval.

Sylvie Meaume

Maarten J. Lubbers

Rytis Rimdeika

Robert Strohal

CO-OPERATING ORGANISATIONS’ BOARD Reyes Carpintero-Pablos, AFISCeP.be Andrea Bellingeri, AISLeC Alessandro Scalise, AIUC Aníbal Justiniano, APTFeridas Gerald Zöch, AWA Luc Gryson, BFW Vladislav Hristov, BWA Els Jonckheere, CNC Milada Francu, CSLR Dubravko Huljev, CWA Hans Martin Seipp, DGfW Eskild Winther Henneberg, DSFS Anna Hjerppe, FWCS João Gouveia, GAIF J. Javier Soldevilla, GNEAUPP Editorial Board Members Sue Bale, UK Carol Dealey, UK (Editor) Finn Gottrup, Denmark Deborah Hofman, UK Martin Koschnik, Portugal Zena Moore, Ireland Marco Romanelli, Italy Zbigniew Rybak, Poland José Verdú Soriano, Spain Rita Gaspar Videira, Portugal Peter Vowden, UK

Christian Münter, ICW Ints Udris, LBAA Mark Collier, LUF Kestutis Maslauskas, LWMA Corinne Ward, MASC Hunyadi János, MST Suzana Nikolovska, MWMA Anne Wilson, NATVNS Marcus Gürgen, NIFS Louk van Doorn, NOVW Arkadiusz Jawień, PWMA Rodica Crutescu, ROWMA Hubert Vuagnat, SAfW Goran D. Lazovic, SAWMA Mária Hok, SEBINKO

Sylvie Meaume, SFFPC Christina Lindholm, SSIS Jozefa Koskova, SSOOR Guðbjörg Pálsdóttir, SUMS Saša Borović, SWHS Magnus Löndahl, SWHS Michael Clark, TVS Jasmina Begić-Rahić, URuBiH Barbara E. den Boogert-Ruimschotel, V&VN Skender Zatriqi, WMAK Georgina Gethin, WMAOI Sandi Luft, WMAS Bülent Erdogan, WMAT Leonid Rubanov, WMS (Belarus)

EWMA Journal Scientific Review Panel Paulo Jorge Pereira Alves, Portugal Caroline Amery, UK Michelle Briggs, UK Mark Collier, UK Bulent Erdogan, Turkey Madeleine Flanagan, UK Milada Franců, Czech Republic Peter Franks, UK Francisco P. García-Fernández, Spain Luc Gryson, Belgium Alison Hopkins, UK Gabriela Hösl, Austria

For contact information, see www.ewma.org

Zoltán Kökény, Hungary Susanne Lauth, Denmark Christian Münter, Germany Andrea Nelson, UK Pedro L. Pancorbo-Hidalgo, Spain Hugo Partsch, Austria Patricia Price, UK Rytis Rimdeika, Lithuania Salla Seppänen, Finland Carolyn Wyndham-White, Switzerland Gerald Zöch, Austria

Dear Readers

Science, Practice and Education 5 Rationale for compression in leg ulcers with mixed, arterial and venous aetiology Hugo Partsch

10 Pressure ulcers in Belgian hospitals: What do nurses know and how do they feel about prevention?

D. Beeckman, T. Defloor, L. Schoonhoven, K. Vanderwee

13 Nutritional Supplement is Associated with a Reduction in Healing Time and Improvement of Fat Free Body Mass in Patients with Diabetic Foot Ulcers P. Tatti, A.E. Barber, P. di Mauro, L. Masselli

21 Chronic wounds, non-healing wounds or a possible alternative? M. Briggs

25 Silver-impregnated dressings reduce wound closure time in marsupialized pilonidal sinus A. Koyuncu, H. Karadaˇ, A. Kurt, C. Aydin, O. Topcu

29 Venous leg ulcer patients with low ABPIs: How much pressure is safe and tolerable? J. Schuren, A. Vos, J.O. Allen,

36 Adherence to leg ulcer treatment: Changes associated with a nursing intervention for community care settings

A. Van Hecke, M. Grypdonck, H. Beele, K. Vanderwee, T. Defloor

Background Article 38 A Social Model for Lower Limb Care: The Lindsay Leg Club Model

t the EWMA Conference in May 2010, the EWMA Patient Outcome Group presented the document “Outcomes in controlled and comparative studies on non-healing wounds – Recommendations to improve quality of evidence in wound management” (Gottrup, Apelqvist, Price; 2010). This happened less than two years after the establishment of the EWMA Patient Outcome Group in October 2008. With this d ocument, the group aims to enter a constructive discussion with various relevant groups, in order to stimulate a general improvement in the quality of evidence in wound management. In this issue of the EWMA Journal, you will find a summary of the document presenting the recommendations and key messages discussed in the full document (available for download at www.ewma.org). EWMA has received numerous comments, feedback and congratulations from various interested groups. We have received strong support from clinicians as well as industry members for the underlying aim of the document. This creates a good basis for the implementation activities which have been initiated during summer 2010 and will continue in the years to come. Successful implementation requires an active strategy for involvement of all relevant groups, including clinicians, industry employees from the medical departments, reimbursement authorities and public health authorities on both a national and European level.

M. Clark

EBWM 42 Abstracts of recent Cochrane reviews S. Bell-Syer

EWMA 46 EWMA Journal and International Journals 48 The EWMA Patient Outcome Group F. Gottrup, J. Apelqvist, P. Price

56 Introducing the EWMA Master Course Z. Moore

58 The EWMA UCM L. Gryson, Z. Moore

60 EWMA 2010, Geneva S. Bale

64 Appreciations 65 EWMA Activities Update 66 The Cooperating Organisations Board Meeting M. Romanelli

68 Corporate Sponsor Contact Data

Organisations 70 Calendar 71 13th EPUAP Meeting in Birmingam, UK T. Young, A. Gefen

72 Report from the 13th annual meeting of DGfW K. Knobloch, M. Koschnick

The EWMA Patient Outcome Group will secure a thorough dissemination of the document through publication of summary translations in national journals, full document translations and presentations at relevant meetings; all in cooperation with the Cooperating Organisations of EWMA. However, the primary objective of the implementation plan is to secure an impact on a) the use of outcome in studies of non-healing wounds and b) the quality of evidence within wound management. Therefore further steps need to be taken to secure implementation of the recommendations. One of the main activities will be to request endorsement of the document from key institutions and to support active use of the recommendations in wound management studies. These activities will be followed closely. In relation to further improving this process, any feedback or initiatives from EWMA members or readers of the EWMA Journal, regarding the content, aim or implementation of the document, will be highly appreciated. In the future years, EWMA hopes to continue the work of the Patient Outcome Group by initiating new projects with the aim to meet some of the other challenges related to establishing evidence in wound management. Finn Gottrup, Jan Apelqvist and Patricia Price

74 Cooperation between WMAS and EWMA N. K. Leskovec

76 Wound Management Society officially registered in Belarus L. Rubanov, R. Rimdeika

Reference: Gottrup F, Apelqvist J, Price P: Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management, Journal of Wound Care 2010; 19: 237-268.

78 Cooperating Organisations Electronic Supplement October 2010: ewma.org / english / publications / ewma-journal / EWMA Journal 2010 vol 10 no 3 electronic-supplmnt.html

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Find out more about AQUACEL® Ag dressing. Visit: www.convatec.com *As demonstrated in vitro3 1. Jones S, Bowler PG, Walker M. Antimicrobial activity of silver-containing dressings is influenced by dressing conformability with a wound surface. WOUNDS. 2005;17(9):263-270. 2. Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber dressing. Wound Repair Regen. 2004;12(3):288-294. 3. Antimicrobial activity of silver-containing wound dressings using a shallow wound microbial model. WHRI3307 MA143. 2010 Data on File. ConvaTec. AQUACEL, Versiva, Versiva XC and Hydrofiber are registered trademarks of ConvaTec Inc. All other trademarks are the property of their respective owners. © 2010 ConvaTec Inc. AP-009364-MM [AM,EM]

Science, Practice and Education

Rationale for compression in leg ulcers with mixed arterial and venous aetiology ABSTRACT The term of “mixed ulcers” is used for cases in which there is a coincidence of arterial and venous pathology. A complete correction of the underlying pathophysiology by restoring both arterial inflow and venous return can rarely be achieved, so compression therapy will remain a cornerstone of management. A modified technique using inelastic material and reduced compression pressure of 20-30 mmHg is recommended in patients with an ankle brachial pressure index (ABPI) between 0.5 and 0.8. Such bandages are able to decrease oedema and thereby increase the nutritional skin blood flow. Specially designed intermittent pneumatic pressure pumps lead to an improvement of arterial flow mainly by releasing vasoactive mediators from the endothelial cells. Inelastic bandages were also shown to be very effective concerning an improvement of the venous pumping function, even when applied with low pressure. Key-words: leg ulcers, mixed ulcers, arterial occlusive disease, compression therapy Introduction Arterial ulcers may be defined as skin defects due to peripheral arterial occlusive disease (PAOD), which, in addition to arterial occlusions in the large arterial stems, also involves local skin areas. Although arterial ulcers are usually lumped together with arterial gangrene as one entity of “critical ischemia” these entities should be differentiated based on clinical criteria. Typically arterial ulcers are situated over bony prominences and on the lateral aspect of the leg and look punched out, presenting no skin changes in the surrounding skin. The different clinical features can mainly be explained by various anatomical levels of the arterial occlusive disease. Arteriolar occlusions in the skin area of the lateral lower leg in association with hypertension are typical features of Martorell´s hypertensive ischemic leg ulcers.

Such patients with arterial and arteriolar ulceration require clear diagnosis concerning the precise position of the arterial occlusions using Duplex ultrasound and angiography based on which a re-opening procedure by intra-arterial catheter intervention or by vascular surgery may be considered. This clinical entity corresponds to a critical ischemia, which will not be discussed in this paper. The term “mixed ulcers” is used for cases in which there is a coincidence of arterial and venous pathology. In most cases these are venous ulcers with oedema and skin changes with a reduced arterial inflow. Arterial occlusive disease can be found in 1020 % of the population over 60. This explains the fact that also 10-20 % of venous ulcer- patients have PAOD. Most are asymptomatic before the development of tissue loss and only a small minority of patients with intermittent claudication will progress to arterial ulceration. If clinical symptoms of arterial occlusive disease are absent, a high index of suspicion is needed to detect such cases by instrumental methods. Doppler pressure measurements and non-invasive methods to detect blood flow in the distal leg or in the toes are mandatory to diagnose or to exclude accompanying PAOD. Severe cases presenting with predominant clinical symptoms of claudication or rest pain showing systolic ankle pressures of less than 60 mmHg, an ABPI less than 0.5 or a toe pressure of less than 30 mmHg need to be referred to a vascular specialist and should be managed like patients with critical ischemia. Risk factors for arterial occlusive disease include smoking, diabetes, age, gender, hyperlipidemia, arteriosclerosis (coronary disease, cerebrovascular disease), renal insufficiency, hyper viscosity or hypercoagulable states, nonambulatory status, hypertension, and associated vasculitis.

Hugo Partsch, M.D Professor of Dermatology Medical University Vienna Chair of the International Compression Club Hugo.Partsch@ meduniwien.ac.at Conflict of Interest: None

 EWMA Journal

2010 vol 10 no 3

Arterial and mixed ulcers are painful and often resistant to conventional therapy. Arterial revascularisation should be undertaken whenever possible. However, also conservative methods may heal the ulcers.1,2 Deep surgical excision (â&#x20AC;&#x153;shavingâ&#x20AC;?) and mesh-grafting may be successful and mixed cases also benefit from abolishment of venous reflux.3. Compression therapy in the presence of PAOD is a controversial topic. A recent international guideline4 recommended the use of mild to moderate inelastic compression with reduced pressure in patients with mixed ulcers and an ankle brachial pressure index between 0.5 and 0.8. Some positive arguments favouring compression will be discussed below. Fig.1: Vicious circle can be interrupted by reduction of oedema using compression which can be achieved with low pressure.

Aim and efficacy of compression therapy in mixed ulcers Important targets of compression therapy in patients with mixed leg ulcers are: 1. Reduction of oedema 2. Improvement of microcirculation 3. Increase of arterial inflow 4. Improvement of venous and lymphatic drainage. 1. Oedema reduction In patients with mixed ulceration oedema is not only caused by venous incompetence and inflammation as in purely venous cases, but, in addition, also by some specific features of the arterial component: Patients with PAOD often suffer from pain in the lying position due to the reduced arterial perfusion pressure and therefore tend to spend much of their time mainly in a sitting position. Immobile sitting enhances fluid extravasation into the tissue, which then will lead to a reduction of the density of blood capillaries nourishing a certain skin area. The oedema fluid keeps blood capillaries apart thereby enlarging the perfusion distances between capillaries and tissue cells and decreasing cellular nutrition. Ischemic pain due to a deficiency of oxygen will therefore increase. A defective veno-arteriolar reflex plays an additional role. In normal humans there is a physiological axon reflex closing a considerable part of the capillary filtration area by innervation of precapillary arteriolar sphincters whenever the venular pressure increases. This oedemaprotective mechanism is impaired in patients with PAOD so that large capillary surfaces are open to enhanced filtration. Compression is able to reduce fluid filtration into the tissue and to interrupt the vicious circle of pain-sittingoedema formation-ischemic reaction and pain (Fig. 1).

It has already been shown that a mild pressure of 15-20 mmHg is able to prevent oedema due to prolonged sitting5 and that inelastic material is more effective for oedema reduction than elastic material.6 2. Improvement of microcirculation Several methods have shown an improvement of the dermal microcirculation by compression. Capillary microscopy demonstrated an increase of the capillary density in the skin7 and recent experiments using Laser Doppler fluxmetry endorsed previous findings reported from purely venous disease8 that compression up to a pressure of 40 mmHg is able to increase skin blood flow. Pressure induced vasodilatation has been described as a physiological phenomenon which may be defective in neuropathic patients and in diabetics.9 Intermittent pressure waves were shown to reduce leucocyte adhesion and to activate the release of different antiinflammatory, anti-coagulatory and vasodilating mediators (nitric oxygen) from the endothelial cells.10 3. Increase of arterial inflow Using nuclear magnetic resonance flowmetry, Mayrovitz was able to show an increase of the pulsating arterial blood flow in the lower leg under multi-component bandages in healthy volunteers.11 These findings mirror the effects of compression on the microcirculation discussed above. In a recent study no negative influence of inelastic compression bandages on arterial inflow was shown in patients with mixed ulcers.12 However, extreme caution is necessary when compression is applied to legs with severe PAOD. Several reports

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Science, Practice and Education

Fig. 2: Pressure measured 12 cm above the inner ankle under a zink paste bandage applied without tension. The resting pressure in the lying position is 18 mm Hg, dorsiflexions produce pressure peaks up to 50 mm Hg creating a “massaging effect” to the leg. By standing up the pressure rises to 60 mm Hg. This completely inelastic bandage will be well tolerated in bed but at the same time is able to counteract gravity in the upright position.

have demonstrated skin necrosis as a complication of compression therapy, even with thromboprophylactic stockings.13 This may happen if sustained external compression pressure exceeds the intra-arterial perfusion pressure of nutritional skin arterioles. If the perfusion pressure behind an arterial occlusion is 50 mmHg or lower, it is obvious that sustained compression applied with the same or even higher pressure will block the arterial inflow leading to ischemia. Such adverse events may happen especially when using elastic textiles, which can sustain pressure for up to a week. In contrast inelastic material applied with mild pressure does not only lose pressure over time but also exerts much lower pressure in the supine than in the upright position (Fig 2). With every kind of bandage it is essential to check the skin carefully after a few days, especially after the first visit. The patient should be instructed to come back if pain and discomfort gets worse. Measurement of the systolic ankle pressure by a Doppler probe is a useful method of assessing the arterial perfusion pressure of the leg. Due to the variations of individual blood pressure measured in the arm the value of the systolic ankle pressure contains more practical information than the ABPI. Table I shows suggestions to adjust compression pressure to the individual arterial perfusion pressure at the ankle level.

Table I: Adjusting the compression pressure to the arterial perfusion pressure. (Ankle pressure measured by a Doppler probe, compression pressure measured at the distal lower leg, in lying position) Arterial perfusion pressure (= ankle pressure) < 60 mmHg ABPI <0,5 50-100 mmHg ABPI 0,5-0,8 > 100 mmHg ABPI >0,8

Kind of compression (compression pressure) Intermittent pneumatic compression (IPC), no sustained compression IPC, modified compression (inelastic material with reduced pressure), 20-30 mmHg Compression pressure adjusted to the severity of oedema and leg dimension (>30 mmHg)

In cases where media sclerosis or arterial calcification occur, especially in diabetics or in patients with kidney disease, but also in patients with a large ankle circumference and massive skin fibrosis, it may happen that the distal arteries of the lower leg cannot be compressed even by a cuff pressure exceeding 200 mmHg. In such cases other instrumental methods are needed to assess arterial inflow. Sustained compression needs to be clearly differentiated from intermittent pressure therapy, which has been shown very efficient in increasing arterial blood flow even in patients with severe arterial ischemia.14 Especially designed pumps have been developed for this important indication. It may be speculated that inelastic compression material producing high pressure peaks during ankle movement could also work in a similar fashion (“massaging effect”, Fig. 2). Myogenic relaxation of the arterial wall, release of vasoactive substances from the endothelial cells 

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21st Conference of the European Wound Management Association gual: Bilin French sh & e ltané Engli simu ais n o i t ç c Tradu lais et Fran Ang

EWMA 2011

and reduction of the arterio-venous pressure gradient has been discussed as possible mechanisms explaining such effects. 4. Improvement of venous and lymphatic drainage Venous insufficiency is the primary and dominating feature in most patients with mixed ulceration. Several effects of compression on venous and lymphatic drainage have been reported. Compression is able to reduce venous reflux, increase venous pumping function, reduce ambulatory venous hypertension and improve lymphatic drainage.15 Several experiments showed that inelastic compression material, applied with the same pressure, is superior to elastic material exerting a more pronounced massaging effect on the veins. Recently it was demonstrated that inelastic bandages being applied with a low resting pressure of around 20 mmHg are very effective in increasing the ejection fraction of the calf pump in patients with venous insufficiency.16 Future studies are needed to define a pressure range for tailored compression devices, which will optimally reduce oedema, increase arterial flow during exercise and improve venous pumping function without detrimental effects in patients with mixed ulceration. References 1. Marston WA, Davies SW, Armstrong B, Farber MA, Mendes RC, Fulton JJ, Keagy BA. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg. 2006 Jul;44(1):108-114 2. Humphreys ML, Stewart AH, Gohel MS, Taylor M, Whyman MR, Poskitt KR. Management of mixed arterial and venous leg ulcers. Br J Surg. 2007 Sep;94(9):1104-7. 3. Obermayer A, Göstl K, Partsch H, Benesch T. Venous reflux surgery promotes venous leg ulcer healing despite reduced ankle brachial pressure index. Int Angiol. 2008 Jun;27(3):239-46. 4. World Union of Wound Healing Societies (WUWHS). Principles of best practice: Compression in venous leg ulcers. A consensus document. London: MEP Ltd, 2008 5. Partsch H, Winiger J, Lun B. Compression stockings reduce occupational swelling. J Derm Surg. 2004;30: 737-43 6. Van Geest AJ, Veraart JC, Nelemans P, Neumann HA. The effect of medical elastic compression stockings with different slope values on oedema. Measurements underneath three different types of stockings. Dermatol Surg. 2000 26:244-7 7. Bollinger A, Fagrell B. Capillary microscopy. Hofgreve & Huber, Bern, 1990 8. Abu-Own A, Shami SK, Chittenden SJ, Farrah J, Scurr JH, Smith PD. Microangiopathy of the skin and the effect of leg compression in patients with chronic venous insufficiency. J Vasc Surg 1994;19: 1074-1083

25 -27 MAY 2011 · BRUSSELS · BELGIUM

9. Fromy B, Sigaudo-Roussel D, Gaubert-Dahan ML, Rousseau P, Abraham P, Benzoni D, Berrut G, Saumet JL. Aging-associated sensory neuropathy alters pressureinduced vasodilation in humans. J Invest Dermatol. 2010 Mar;130(3):849-55. 10. Chen AH, Frangos SG, Kilaru S, Sumpio BE. Intermittent pneumatic compression devices – physiological mechanisms of action. Eur J Vasc Endovasc Surg 2001; 21(5):383-392. 11. Mayrovitz HN Compression-induced pulsatile blood flow changes in human legs. Clin Physiol 1998,18:117-24 12. Top S, Arveschoug AK, Fogh K. Do short-stretch bandages affect distal blood pressure in patients with mixed aetiology leg ulcers? J Wound Care. 2009 Oct;18(10):439-42. 13. Perrin M Skin necrosis as a complication of compression in the treatment of venous disease and in prevention of venous thromboembolism. Phlebolymphology2008;15:27-30 www.phlebolymphology.org 14. Kalodiki E, Giannoukas AD Intermittent pneumatic compression (IPC) in the treatment of peripheral arterial occlusive disease (PAOD)--A useful tool or just another device? Eur J Vasc Endovasc Surg. 2007 Mar;33(3):309-10.. 15. Partsch H, Flour M, Smith PC , Benigni JP, Cornu-Thénard A, Delis K, Gniadecka M, Mariani F, Mosti G, Neumann HAM, Rabe E, Schuren J, Uhl JF. International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP. Int Angiol. 2008 Jun;27(3):193-219. 16. Mosti G, Partsch H. Is low compression pressure able to improve venous pumping function in patients with venous insufficiency? Phlebology 2010;25:145-50

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2010 vol 10 no 3

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Managing pressure ulcers

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Whenever a patients’ weight isn’t distributed evenly over the Hill-Rom’s intelligent sensing technologies focus on reacting largest possible area, discomfort increases and skin damage to the depth of immersion correlated to the specific patient becomes more likely – that’s what we all know. When a patient morphology and body position. The result is optimized pressure sinks too deep into a pressure redistributing surface he might redistribution with real time and automatic pressure adjustment be inactivated, or even bottom out. But how to determine the - regardless of the patient’s size, shape, weight or position. right level of immersion and envelopment? Hill-Rom’s concept of I-mmersionTM Therapy helps to balance these requirements, More than just products enabling you to achieve a Safe Skin environment. But we do more than that. With Assist 2.0, Hill-Rom provides a three-step quality process, offering a wealth of knowledge Since the days of Air Fluidised therapy, Hill-Rom’s philosophy and experience to help indentify and solve challenges within has always been to deliver the lowest required surface pressures your facility. With Hill-Rom Safe Skin e-learning programme, to prevent compression of vulnerable tissues. Unique pressure learning about a particular topic will be possible in a variety control technologies in all Hill-Rom® dynamic surfaces ensure of ways, using a variety of means – any time, any place. adequate immersion at all times – without impacting on patient’s mobility, and without creating peak pressures in It is the right combination of people, process and technology alternating modes. Together with our advanced micro climate which enhances outcomes for patients and their caregivers. management option, this provides a holistic solution which You got the right people, and we provide the right technologies supports you managing your patients’ risk of skin damage. and tools. Together we can establish the processes you need. Thus, Hill-Rom’s I-mmersion Therapy is in alignment with the recommendations expressed in the NPUAP/EPUAP Consensus Guidelines published in 2009. TM

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Science, Practice and Education

Pressure ulcers in Belgian hospitals:

What do nurses know and how do they feel about prevention?

Dimitri Beeckman PhD candidate 1) PhD candidate, Nursing Science, Department of Public Health, Faculty of Medicine and Health Sciences, Ghent University, Gent, Belgium 2) Research Staff, Department of Bachelor in Nursing, University College Arteveldehogeschool Ghent, Gent, Belgium Tom Defloor, RN, PhD Lisette Schoonhoven, RN, PhD Katrien Vanderwee, RN, PhD Corresponding author: D. Beeckman, dimitri.beeckman@ugent.be Conflict of interest: none

BACKGROUND Pressure ulcers are internationally recognised as a patient safety problem and are an indicator of quality of care.1,2 A 2008 study indicated a prevalence of pressure ulcers of 12.1 % in Belgian hospitals (Category I-IV)3: Only 10.8 % of the patients at-risk received fully adequate prevention in bed as well as when seated.3 Evidence-based guidelines for pressure ulcer prevention have been developed and promoted by programmes and campaigns of authoritative organizations. However, non-adherence to pressure ulcer guidelines is reported frequently.4 Negative attitudes and lack of knowledge may act as barriers to using guidelines in clinical practice.5,6 AIM This study aims to (1) study the knowledge and attitudes of nurses about pressure ulcer prevention in Belgian hospitals and (2) explore the correlation between knowledge and attitudes, and the application of fully adequate prevention. METHODS A cross-sectional multi-centre study was performed in a random sample of 14 Belgian hospitals, representing 207 wards. Out of that group, 94 wards were randomly selected (2105 patients). The uniform methodology of the European Pressure Ulcer Advisory Panel (2007) was used to collect the data. The data collection instrument included five categories of data: general data, patient data, risk assessment, skin observation, and prevention. Five nurses from each participating ward completed the extensively validated Pressure Ulcer Knowledge Assessment Tool (PUKAT) and the Attitude towards Pressure Ulcers instrument (APUp).7,8 The PUKAT includes 26 multiple choice questions on etiology, classification, nutrition, risk

assessment, and preventive methods to reduce the magnitude / duration of pressure and shear.7 A mean score of > 60 % was considered to be satisfactory in this study. The APUp includes 13 items and reflects five subscale domains: 1) personal competency to prevent pressure ulcers; 2) priority of pressure ulcer prevention; 3) impact of pressure ulcers; 4) responsibility in pressure ulcer prevention; 5) confidence in the effectiveness of prevention.8 A mean score of > 75 % was considered to be satisfactory in this study. In total, 553 nurses participated. Independent sample t-tests were used to detect differences between knowledge and attitude scores. A logistic regression analysis was performed to evaluate the effect of knowledge and attitudes on the application of preventive measures. Statistical analyses were performed using SPSS® 15. An  level of 0.05 was used for all statistical tests. The study was conducted between April and May 2008.

RESULTS An overall prevalence (Category I-IV) of 13.5 % (284/2105) was found. Non-blanchable erythema (Category I) was observed in 5.6 % (117/2105) of the patients. Approximately 30 % (625/2105) of the patients were at-risk (Braden < 17 and /or exhibited the presence of a pressure ulcer). Only 13.9 % (87/625) of the patients at-risk received fully adequate prevention in bed and when seated, while 6.2 % only received adequate preventive care when seated in an armchair. The mean knowledge and attitude scores were 49.7 % (SD=11.2 %) and 71.3 % (SD=15.7 %), respectively. An overall correlation was found between knowledge and attitudes towards pressure ulcer

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2010 vol 10 no 3

prevention (r=0.41, p< 0.001). The application of fully adequate prevention on a nursing ward was significantly correlated with the attitudes of the nurses (OR= 3.07, p=0.05). No independent correlation was found between knowledge and the application of fully adequate prevention (OR=0.75, p=0.71).

CONCLUSIONS The overall adequacy of pressure ulcer prevention in Belgian hospitals was poor and knowledge in nurses was inadequate. Apart from that, only half of the nurses showed satisfactory attitude scores. Attitudes of nurses’ towards pressure ulcers were significantly correlated with the application of fully adequate prevention. Knowledge was not significantly correlated with the application of fully adequate prevention. Strategies to improve both knowledge and attitudes towards pressure ulcer prevention should be developed and evaluated. m References: 1. Baharestani M, Black J, Carville K, Clark M, Cuddigan J, Dealey C, Defloor T, Harding K, Lahmann N, Lubbers M, Lyder C, Ohura T, Orsted H, Reger S, Romanelli M, Sanada H. Dilemmas in measuring and using pressure ulcer prevalence and incidence: an international consensus. J Wound Care. 2009; 6(2): 97-104. 2. Gunningberg L, Stotts N. Tracking quality over time: what do pressure ulcer data show? Int J Qual Health Care. 2008; 20(4): 246-253. 3. Defloor T, Bouzegta N, Beeckman D, Vanderwee K, Gobert M, Van Durme T. Pressure ulcer prevalence in Belgian Hospitals in 2008. Brussels, Federal public service: Health, Food chain safety and environement. pp. 120. 4. Panagiotopoulou K, Kerr S. Pressure area care: an exploration of Greek nurses’ knowledge and practice. J Adv Nurs. 2002; 40(3):285-296. 5. van Gaal B, Schoonhoven L, Vloet L, Mintjes J, Borm G, Koopmans R, van Achterberg T. The effect of the SAFE or SORRY? programme on patient safety knowledge of nurses in hospitals and nursing homes: A cluster randomised trial. Int J Nurs Stud. 2010; doi:10.1016/j.ijnurstu.2010.02.001 6. Grol R, Wensing M. What drives change? Barriers to and incentives for achieving evidence-based practice. Med J Aust. 2004; 180(6 Suppl.): 57-60. 7. Beeckman D, Vanderwee K, Demarré L, Paquay L, Van Hecke A, Defloor T. Pressure ulcer prevention: development and psychometric validation of a knowledge assessment instrument. Int J Nurs Stud. 2010a; 47(4): 399-410.

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8. Beeckman D, Defloor T, Demarré L, Van Hecke A, Vanderwee K. Pressure ulcers: development and psychometric evaluation of the Attitude towards Pressure ulcer Prevention instrument (APuP). Int J Nurs Stud. 2010b; doi:10.1016/j. ijnurstu.2010.04.004.

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Science, Practice and Education

Nutritional Supplement is Associated with a Reduction in Healing Time and Improvement of Fat Free Body Mass in Patients with Diabetic Foot Ulcers Abstract Background & Aim: Patients with diabetes are at high risk of developing foot ulcers (DFU). The medical literature is replete with claims of improved wound healing in DFU using a variety of strategies. However, randomized controlled trials are often difficult to accomplish in DFU, as there are often multiple variables to control, making valid comparisons virtually impossible. In the current study, recurrent DFU in the same patients with identical wound and medical care were studied before and after the addition of an oral nutritional supplement, thus eliminating the variables of site of ulcer, relative pressure on the wound, co-morbid diseases and wound care methods. Methods: Twelve patients with recurrent DFU were included in this retrospective analysis. Initially, all participants underwent a general physical examination and complete blood count. Patients’ serum was tested for glucose, glycosylated haemoglobin A1c (HbA1c), electrolytes, creatinine, and protein electrophoresis. Body composition was analyzed using bioelectrical impedance analysis. After documented recurrence of ulcers, each patient received a mixture of -hydroxy- -methylbutyrate, glutamine and arginine*, a nutritional supplement clinically shown to support wound healing and build lean body mass. Optimization of medical management and standard wound care practices were employed in all patients. Results: There were no differences in blood counts and serum chemistries and HbA1c levels before and after supplementation. Ulcer duration was significantly decreased after supplementation (from 246.00 + 62.00 to 80.70 +11.30 days, p<0.001). Body cell mass index also showed improvement in supplemented individuals (from 9.6 +0.25 to 8.883+ 0.28, p <0.001).

Conclusions: The reduction in ulcer duration and improvements in fat-free mass associated with supplementation of the combination of -hydroxy- -methylbutyrate, glutamine and arginine reported herein suggest its potential clinical usefulness in treatment of diabetic foot ulcers.

Introduction Of the 150 million people in the world with diabetes, at least 15%-25% are expected to develop one or more foot ulcers in their lifetime.1,2 Approximately 40% of DFU are attributable to the loss of sensation or neuropathic. The treatment of diabetic neuropathic foot ulcers lacks a clear cut, effective treatment that is universally accepted. Randomized controlled trials in patients with DFU are difficult to conduct because of the wide variety of factors associated with the ulcer, including different aetiology, size, depth, position, conformation, infection, relative pressure, therapeutic interventions, degree of glycaemic control, and nutritional status. While the aetiology is certainly multi-factorial, it is true that nutritional disturbances have a role in causing, aggravating and maintaining the lesion. Within the past 12 months, we introduced a proprietary blend of arginine, glutamine and -hydroxy-methybutyrate (Arg-Glu-HMB) to patients with DFU in our practice. To determine the role of this supplement, we examined its effect in patients with recurring DFU. Applying two differential treatments, sequentially in the same individual, with the same ulcer treatment and to an ulcer in the same place reduces the biological variability that may represent a confounder in many retrospective studies. We evaluated whether adding this amino acid blend to the wound care regimen of patients with a recurrent DFU would improve the healing process; therefore, the objective of this study was to compare the time to re-epithelial-

Patrizio Tatti, M.D. Chief of Endocrinology and Diabetes Unit, ASL RMH, Rome, Italy

Annabel E. Barber, M.D. Professor of Surgery, University of Nevada School of Medicine, USA Patrizia di Mauro Leonardo Masselli Endocrinology and Diabetes Unit, ASL RMH, Rome, Italy Corresponding author: Patrizio Tatti, info@patriziotatti.it Conflict of interest: none



* (Abound®, Abbott Laboratories,Chicago, IL, USA)

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2010 vol 10 no 3

Science, Practice and Education Table 1. Patient Characteristics Initial and Recurrent Ulcers

Age

Sex

50 69 72 61 59 58 62 64 64 44 72 73

M F M M M M M M M M M M

Previous Ulcer Treated without Arg-Glu-HMB HbA1c Location Duration Outcome (%) (days) 9.7 1st toe 150 Surgery 10 Ankle 700 Partially healed 11 Forefoot 650 Surgery 9 Forefoot 180 Partially healed 9 Forefoot 210 Partially healed 7.7 Forefoot 120 Healed 9.9 Forefoot 240 Healed 9 Forefoot 120 Partially healed 9 Forefoot 120 Healed 11 1st toe 152 Healed 11 Forefoot 180 Surgery 9.4 5th toe 90 Partially healed

isation without further discharge as well as changes in glycosylated haemoglobin A1C (HbA1c) and fat-free body mass between treatment periods.

Materials and Methods In the first half of 2009, a blend of arginine, glutamine and HMB became available in our practice and was extended to all the cases of neuropathic DFU. Among this group of patients, 12 had a relapsing condition: seven patients with recurring wounds in the same area and with exactly the same characteristics, and five patients previously treated with surgical resection of the affected area and who presented with a new lesion in a different location on the foot, but with the same characteristics as their previous wound. The relevant data are in Table 1. Prior to initial treatment in both periods, all patients underwent a general physical examination and a routine check for blood glucose, HbA1c, serum creatinine, complete blood count, protein electrophoresis, electrolytes, and overnight (12 h) urinary protein excretion. All patients monitored their blood glucose levels regularly. At the patient’s first visit, the ulcer was photographed and measured. Body composition was also measured using bioelectrical impedance analysis** using the method described by Dittmar.3 In addition, medications were adjusted to improve diabetes management and hypertension as needed. Curettage was performed if deemed appropriate by the physician. Wounds were cultured and infected wounds were treated with appropriate antibiotics. A follow up visit was scheduled within a week; at that time, the treatment was further adjusted, if indicated. In addition, the patients were referred to the dietician who determined energy needs based on age and activity level. For the overweight or obese patients, a slightly hypo-caloric diet, with 20% reduction of total intake was prescribed with the support of a highly nutritional

New or Recurrent Ulcer Treated with Arg-Glu-HMB HbA1c Location Duration (%) (days) 10 2nd - 3rd toe 90 9.8 Ankle 68 10.2 Heel 60 11 Forefoot 90 9.9 Forefoot 90 8.1 Forefoot 60 8.8 Forefoot 40 8.7 Forefoot 90 9.1 Forefoot 68 10.6 1st - 2nd toe 90 11.9 Heel 60 8.9 5th toe 56

formula. The recommended protein content of the diet was at least 20%. The patients’ diet prescriptions remained the same for the previous ulcer event. The patients were followed up weekly until their wounds closed. For the treatment of recurring DFU, the formula was started at the subsequent visit. Thus the only difference between the treatment periods was the addition of HMB, glutamine and arginine supplementation. Pertinent medical data were recorded from the patients’ electronic records and included laboratory values and results of body composition analysis. The time when patients first observed the presence of wounds was used to calculate the time of the first medical evidence of the disease. In three of the patients, the ulcer had not healed and the affected area was surgically removed. This situation did not occur in the second phase involving supplementation.

Results The supplements were well tolerated in all patients. There was no worsening of overall medical conditions observed in any of those who received supplementation. Table 1 displays patient demographics. Body Cell Mass significantly increased with supplementation. The mean mass associated with the initial episode was 8.83 kg/m2 + 0.28 as compared to 9.6 + 0.25 after supplementation (paired t test, p<0.05). The major study results are presented in Table 2. Prior to instigating supplementation with HMB, glutamine and arginine, only four of the previous ulcers healed; three ulcers were terminated with the removal of the damaged toe, mostly due to supervening infections. The remaining wounds were partially healed and further treatments were 

** (Akern BIA101, Florence, Italy)

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Science, Practice and Education Table 2. Duration of Ulcers Variable Age (Years) HbA1c (previous episode of ulceration)1 Duration (previous episode of ulceration) HbA1c (second episode of ulceration) Duration (second episode of ulceration)1 1

Mean + SE 62.6+2.55 9.6+ .29 246+62 9.67+.57 80.7+11.27

Range 44-73 7.7-11 90-700 11-9.67 40-180

data logarithmically transformed

abandoned. In these subjects, the time to healing was defined as the time in which the treatment was interrupted after marked improvement, and the patient was advised to maintain good glycaemic control and appropriate foot care practice. In Table 2, the previous time to healing as defined before was in average 247 days, compared to approximately 83 days after supplementation. After logarithmic transformation was performed, the difference between treatment periods was highly statistically significant (P < 0.001). We also recalculated this same parameter after removing patients with partially healed ulcers and the difference remained significant at the nominal value of p = 0.014. However, we did not find a correlation between time to heal and HbA1c at the time of the first ulcer (r = 0.497, p=NS). However, there was a highly significant correlation during supplementation with HMB, arginine and glutamine in recurring ulcers (r = 0.9, p=.045).

Discussion Non-healing wounds have devastating effects on an individual’s quality of life. Patients with chronic wounds report physical discomfort, pain, swelling and exudate which can be malodorous. These factors can impact employment, limit mobility, cause sleeping problems, and lead to anxiety, depression and social isolation.4 Nutritional interventions have previously been shown to be beneficial in the management of DFU.2 Randomized clinical studies are difficult to conduct in most wounds, but are especially difficult in DFU due to the intrinsic variability of the wound, glycaemic control, presence of infection, and other afflictions. HbA1c is considered the gold standard in evaluating glycaemic control in a diabetic patient, but may be variably influenced by both fasting and postprandial blood glucose levels, and each has a different pathophysiological meaning. Glucose variability also affects wounds’ ability to heal. By using the same subjects we could at least eliminate some of these variables. In this study, the use of the formula restored the HbA1c impact on the treatment, thus removing the interfering effect of malnutrition/accentuated catabolism. It should be considered however that this study also has some

limitations. First the sample is small and thus the results must be confirmed with a larger sample. Another weakness is the fact that we used a previous historical set of data which may have introduced a level of uncertainty on the timing of appearance of the ulcer. It must be recognized however that this problem also applies to the most sophisticated randomized studies, since it is obviously impossible to deal with an ulcer as we deal with a drug, with a washout period and a precise start time. One argument in favour of this study is the biological plausibility that adds in non-numeric fashion to the significance. We also hope that these results will be repeated and the repeatability is another non-numerical support of the statistical results. In the main we think that on a scale of 1a to 5 this observation can be ranked 3b. (www.essentialevidenceplus.com/product/ebm_loe.cfm?show=oxford) In the current study, we observed a significant reduction in healing time when patients with recurring DFU were provided with the blend of HMB, arginine and glutamine (p<.001). Another relevant observation is that the correlation coefficient between the prevailing HbA1c and the time to healing: while the correlation was substantially absent during the first ulcer (p=NS), the relationship between HbA1c and time to healing was highly significant in during the second event, after supplementation (p=.045). In our opinion this divergence can be interpreted to demonstrate that the blend itself was able to solve a “second factor”, interfering with the ulcer, and thus the HbA1c level remains the prevailing factor interfering with the time to healing. This is entirely consistent with the role of the blend that is able to act as an anabolic stimulus in people notoriously living in a catabolic state, characteristic of ongoing diabetic decompensation and the consequent neoglycogenesis that leads to a reduction of the lean body mass. Additionally, not to be overlooked is the fact that most diabetic patients have a very low level of the anabolic hormone testosterone, though this was not measured in this study. Nutritional supplementation with the combination of HMB and specific amino acids can be used safely in a variety of patient types. A meta-analysis has demonstrated the safety of the use of this supplement in patients with 

EWMA Journal

2010 vol 10 no 3

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Science, Practice and Education

cancer-cachexia, AIDS-related wasting, trauma, and older adults with experimental wounds.6-9 In that study, the use of this supplement was associated with improvements in red blood cell count, haematocrit, and lymphocyte count, and emotional profile. Important in this report is a notable change in physicians’ and patients’ expectations in what are traditionally viewed as wounds that are difficult to heal, if at all. Wounds that were non-healing showed marked improvement with the use of this supplement. It may be stated that these wounds, with meticulous local care and optimization of nutrition, would have healed, regardless of the use of the blend. Contrary to that, while some of the non-healing wounds presented here may have eventually healed in a longer period, the expediency of the healing process is apparent and offers several benefits. The decreased time of healing is incalculable, with respect to a patient’s ability to resume his or her activities of daily living. Reports of improvements in quality of life associated with wound healing therapies, including those involving nutritional interventions, are scarce. However, anecdotal evidence from the cases presented in this report indicates that quality of life would likely improve with wound healing, such as improvements in mobility and ability to return to work, upon using the supplement containing HMB, arginine and glutamine after their wounds healed. In summary, the case studies presented herein provide further evidence of the safety and benefits of using a supplement containing HMB, glutamine and arginine on non-healing wounds in patients presenting with complex medical conditions. m

References: 1. Medina A, et al. J Burn Care Rehabil. Jul-Aug 2005;26:306-319. 2. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. Journal of the American Medical Association 2005; 293(2):217-228. 3. Dittmar M, Reber H. New equations for estimating body cell mass from bioimpedance parallel models in healthy older Germans. Am J Physiol Endocrinol Metabo 2001; 281: Issue 5, E1005-E1014 4. Herber OR, Schnepp W, Rieger MA. A systematic review on the impact of leg ulceration on patients‘ quality of life. Health and Quality of Life Outcomes 2007; 5:44. 5. Dhindsa S et Al Testosterone Concentrations in Diabetic and Nondiabetic Obese Men, Diabetes Care June 2010 33:1186-1192) 6. Rathmacher JA, Nissen S, Panton L, Clark RH, Eubanks MP, Barber AE et al. Supplementation with a combination of beta-hydroxy-beta-methylbutyrate (HMB), arginine, and glutamine is safe and could improve hematological parameters. journal of Parenteral and Enteral Nutrition 2004; 28(2):65-75. 7. Clark RH, Feleke G, Din M, Yasmin T, Singh G, Khan FA et al. Nutritional treatment for acquired immunodeficiency virus-associated wasting using -hyroxy-methylbutyrate, glutamine, and arginine: a randomized, double-blind, placebocontrolled study. Journal of Parenteral and Enteral Nutrition 2000; 24:133-139. 8. May PE, Barber A, D’Olimpio JT, Hourihane A, Abumrad NN. Reversal of cancerrelated wasting using oral supplementation with a combination of beta-hydroxy-betamethylbutyrate, arginine, and glutamine. American Journal of Surgery 2002; 183(4):471-479. 9. Kuhls DA, Rathmacher JA, Musngi MD, Frisch DA, Nielsen J, Barber A et al. Beta-hydroxy-beta-methylbutyrate supplementation in critically ill trauma patients. Journal of Trauma 2007; 62:125-132.

Implications for clinical practice: n Diabetic foot ulcers must be treated aggressively and keeping in mind that result from multiple abnormalities n Using a formula with argine, glutamine and HMB can considerably speed the healing process of diabetic foot ulcers provided there is sufficient blood flow to the tissue Acknowledgements We must thank Carolyn Alish and Anne Voss from the Abbott laboratories for supplying us with the relevant medical literature.

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Science, Practice and Education

Chronic wounds, non-healing wounds or a possible alternative? Classification of healing; communicating complexity A great deal has been written in the attempt to understand the wound healing process and the general consensus could be described in a three fold way: some heal in a timely fashion, some take longer than expected and a small percentage never achieve healing despite the best efforts.1 For the majority of people who are faced with an injury they can expect the wound to heal spontaneously with little healthcare intervention. The wound will, it is thought, follow the healing trajectory laid out in Figure 1 (adapted from Falanga 2005).2 However, clinical experience and research has shown that not all people follow this timeline and wound healing will take longer than expected. Such “chronic wounds” have been defined as wounds that have not proceeded through orderly and timely reparation to produce an anatomic and functional integrity after three months.3 It is often suggested that the most common chronic wound types are leg ulcers, pressure ulcers and diabetic ul-

Figure 1: Phases of wound healing

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2010 vol 10 no 3

cers4,5 although any wound type has the potential to become chronic. A large array of factors such as diabetes, increasing age; arterial or venous insufficiency; malignancy, poor nutrition or infection contribute to impaired healing and this list is not exhaustive.1,2,3 It is also worth considering that within a single wound type like leg ulcers it has been suggested that the population may not be homogenous in relation to healing. For example, Johnson (1997) used a descriptive correlation design to study similarities in healing characteristics in older people with leg ulcers (n=156). Using hierarchical cluster techniques she developed a healing topology based on clinical differences in the healing rates from three observed different individual profiles of the leg ulcer sufferers. These were labelled “Rapid healers”; “Slow healers”; and “Non-healers”. Therefore any attempt to classify wound healing reveals a complex interplay between the wound environment, the patient, health professional and the healthcare context in which wound healing interventions are delivered.6 This is reflected in the recent EWMA document “Outcomes in controlled and comparative studies on non-healing wounds – Recommendations to improve quality of evidence in wound management” where the authors present the results of a review of hundreds of trials in wound care with the aim of achieving an evidence-based consensus on an acceptable level of rigour for studies in wound management. They note that in most of the studies they reviewed the wounds were described as ‘chronic’ and that the time frame to

Michelle Briggs, PhD RGN Academic Unit Head, First Contact and Acute Care, Institute of Health and Social Work, Leeds University, UK m.briggs@leeds.ac.uk Conflict of interest: None



define a chronic wound was “one that had not healed for at least 4 - 6 weeks from its first observation at a trial screening visit”. They suggest that “the definition ‘chronic’ should be replaced with the definition ‘non-healing’ as this better reflects the clinical problems experienced by such patients. To use the term ‘chronic’ focuses too much on wound duration, rather than the presenting condition. Ulcers included in studies using this terminology must be separated from those that will spontaneously improve once appropriate treatment is started.”5 It is evident there is benefit from clearly describing a wound population and being able to distinguish between those people who are likely to heal and those who are at risk of not healing; studies have been published to help us in this. For an example, research carried out by Margolis et al suggest that ulcer size, duration and depth are three of the most important factors for predicting healing outcome.7,8 Despite this research we should not underestimate the complexity of being able to predict individual patient outcomes. Falanga (2005) acknowledges that whilst the linear progression paradigm of normal wound healing, shown in figure 1, has been incredibly useful to communicate what we understand about the process of wound healing, we should also be aware that complications occur and in chronic wound healing the trajectory is not reliable, not consistent and people may get stuck in different phases and healing may be impaired. But impaired healing does not mean nonhealing. Whilst healing may not be timely it may still be achievable given the right circumstances.9

What’s the impact of labelling people with a chronic wound or “non-healing”? If some patients’ wounds can be classified as non-healing then could the question be posed “why does the aim of care remain to achieve healing for this group?” What is the evidence for continuing to try and heal a wound that has been open for years, classified non-healing and where the patients may rather be offered wound management plans that include help to normalize their lives rather than heal the wound? Helping people adapt to non-healing may be necessary if a person is going to make sense of the context they are in. This has been mediated through coping strategies such as acceptance and comparison to others worse off and, in a study by Hopkins (2004), there is evidence of these coping strategies being used by the participants to normalize their lives in a positive way when healing isn’t achieved.10

There also may be a tendency to equate non-healing with non adherence. In a focus group study carried out by Morgan and Moffatt (2008) it was concluded that nurses viewed ulcer healing as the priority even when this was unlikely due to the nature of the wound and this differed from the patient’s priority of achieving comfort.11 There was a perceived pressure on the part of the professionals to heal the wounds and if this failed there was the potential to blame the patient in terms of a lack of motivation or adherence to treatment plans. The authors do acknowledge that the views analysed come from only four focus groups and therefore represent a small group of community nurses but they do suggest that the story reflects a group of “embattled community nurses working with ever reducing resources in which their apparent failure to make a difference to the lives of their patients was deeply felt. There is a great deal to be learnt from the experience of the community nurses in this study. Not least the dangers of labelling patients and the central role of communication between patient and nurse particularly regarding the aims of management.” Whilst clinicians and researchers have used the term “nonhealing wounds” when referring to chronic wounds, does this accurately describe the total population in order to direct wound management for the benefit of patients? Is this the experience of researchers, clinicians and with people suffering from chronic wounds?

A possible alternative: Chronic wound population profile Maybe the profile below resonates more closely with the profile of this group of patients or maybe it too has difficulties in this complex field? The proposed levels presented here are a suggestion for a chronic wound population profile for discussion and testing.

Chronic wound population profile n Level 1. Low risk uncomplicated wounds which are likely to heal n Level 2. High risk complicated wounds (hard to heal but with best available care healing is possible) n Level 3. Highly complex patients needing palliative wound care (non-healing wounds that are refractory and not responsive despite best available management and the focus of care should therefore be centred on symptom control)12

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Science, Practice and Education

Figure 2: Assessing levels of complexity (DH 2004) References

These levels are underpinned by work to develop the chronic disease model for population management (see Figure 2) since it could be argued that chronic wounds, like leg ulceration, can be viewed as a chronic condition.10,13 This model has been published in the Department of Health document “Improving chronic disease management” and the model is reproduced here for your reference.14 Treating people with high risk complicated wounds or judging when someone needs to shift the focus of care from healing the wounds to palliation of wound symptoms requires a team approach and good communication. Classification systems, when they work well, can promote good communication between all members of the team, but it is acknowledged there are many potential ways to describe this complex population. m

1. Vowden P, Apelqvist J, Moffatt C 2008 Wound complexity and healing In; European wound management association (EWMA) position document Hard to Heal Wounds London MEP Limited 2-9 2. Falanga V (2005) Wound healing and its impairment in the diabetic foot Lancet 366 17 36-43 3. Werdin F, Tenenhaus M, Rennekampff HO Chronic wound care Lancet 372 1860-1862 4. Gottrup F, Apelqvist J, Price P 2010 Outcomes in controlled and comparative studies on non healing wounds – Recommendations to improve quality of evidence in wound management Journal of Wound Care 19, 6, 239-268 5. Fonder M, Lazarus GS, Cowan DA et al (2008) Treating the chronic wound: a practical approach to the care of non-healing wounds and wound care dressings Journal of the American Academy of Dermatology Feb 185-206 6. Johnson M 1997 Using cluster analysis to develop a healing typology in vascular ulcers Vol. XV ( 2) Journal of Vascular Nursing 45-49 7. Margolis DJ, Allen-Taylor L, Hoffstad O Berlin J A, (2003) Diabetic neuropathic foot ulcers predicting ones which will not appeal the American Journal of Medicine 115 (a) 627-31 8. Margolis DJ, Allen-Taylor L, Hoffstad O Berlin J A (2002) Diabetic neuropathic foot ulcers the association of wound size wound duration and wound grade on healing Diabetes Care 25 (10) 1835-39 9. Falanga 2004 The chronic wound : impaired healing and solutions in the context of wound bed preparation Blood Cells, Molecules and Diseases 32 88-94 10. Hopkins 2004 Disrupted lives: investigating coping strategies for non-healing leg ulcers British Journal of Nursing, 2004,13, (9) 556-563 11. Morgan PA, Moffatt CJ. Non healing leg ulcers and the nurse–patient relationship. Part 2: the nurse’s perspective. International Wound Journal 2008; 5:332–339. 12. Alvarez, OM. Kalinski, C. Nusbaum, J.et al (2007) Incorporating wound healing strategies to improve palliation (symptom management) in patients with chronic wounds..Journal of Palliative Medicine. 10(5):1161-89, Oct 13. Briggs, M.; Flemming K., Living with leg ulceration: a synthesis of qualitative research Journal of Advanced Nursing, 59, 319-443, 2007 14. DH (2004) Improving chronic disease management http://www.dh.gov.uk/en/ Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4075214 downloaded 1st Sept 2010.

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2010 vol 10 no 3

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Science, Practice and Education

Silver-impregnated dressings* reduce wound closure time in marsupialized pilonidal sinus Abstract Objective: Sacrococcygeal pilonidal sinus disease is caused by in-grown-hairs between the buttocks. Surgery is the principal method of treatment. Several surgical methods should offer conditions of fast cicatrisation. In this study we evaluated the effects of silver-impregnated dressings* on wound closure rates in patients with pilonidal sinus disease treated by unroofing and marsupialization. Material-Methods: Forty-three patients with pilonidal sinus disease who were treated by unroofing and marsupialization, were divided into two groups, and selected randomly using the sealed envelope method. In group 1 dry sponge dressing procedures were done (DSD group), and in group 2 silver-impregnated dressing* (SIHD group) procedures were done until the wounds were closed totally. At each visit wound cavity volume was measured. Numbers of dressings used and complete closure time were recorded. Results: There were 20 males and 1 female with mean age 23.6 years (18-30 years) in DSD group and 21 males and 1 female with mean age 23.4 years (18-28 years) in SIHD group. Complete wound closure times were 35.6±3.2 and 27.6±2.8 days in DSD and SIHD group respectively. Wounds closed more quickly in the SIHD group (p<0.05). In both study groups wound cavity volume decreased day by day but in the SIHD group cavity volume was reduced faster and total closure achieved earlier than in the DSD group(p<0.05). Conclusion: For the marsupialized pilonidal sinus wounds, silver-impregnated dressings* reduced wound closure time. This method may provide an important advantage to patients. Key words: pilonidal disease, silver-impregnated hydrofibers, treatment, wound healing.

Introduction Sacrococcygeal pilonidal sinus is a problematic condition probably caused by in-grown hairs between the buttocks. Sufferers tend to be young men and they usually experience a wound that discharges pus-like material and does not heal.1 When a patient with pilonidal sinus is treated the wound is excised and left open for secondary healing or unroofing and marsupialization. The dressing of the open wound becomes an important issue. Silver-impregnated dressing*, a composition of the technology* with 1.2 % silver, is a moisture retentive topical dressing, which can release silver within the dressing for up to 14 days.2 The present randomized study was designed to evaluate the effect of silver-impregnated dressings* on wound closure rates in patients with pilonidal sinus disease treated by unroofing and marsupialization. Material and Methods In this study, 43 patients with pilonidal sinus disease were randomly divided into silver-impregnated dressing* (SIHD) and dry sponge dressing (DSD) groups. The two groups were randomly chosen by a sealed envelope method. Sample size was calculated with power analysis. Test power was estimated as p:0.9087 [ =0.01, b= 0.10, (1- b)=0.90 ]. All operations were performed under spinal anesthesia with the patient placed in prone position. External opening of the sinus was gently cannulated by a stile. The roof of the sinus tract was excised, leaving the bottom intact, and curettage was applied to the posterior wall of the tract and marsupialization was done with 2/0 polypropyl ene suture by continuous manner.

Ayhan Koyuncu, MD Professor Hakan Karada , MD Specialist Atilla Kurt, MD Assistant Professor Cengiz Aydin, MD Professor Omer Topcu, MD Associate Professor Department of General Surgery, Faculty of Medicine, Sivas, Turkey Corresponding author: Ayhan Koyuncu, akoyuncu@cumhuriyet.edu.tr Conflict of interest: none

* Hydrofiber®

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Science, Practice and Education

Table 1 Dressing number and the complete closure time of the study groups DSD SIHD p Dressing number (times) 14.45±2.0 6.3±1.2 <0.05 Complete closure time (days) 35.6±3.2 27.6±2.8 <0.05 DSD = dry sponge dressing; SIHD= silver-impregnated Hydrofiber® dressing

Almost all patients were discharged from the hospital postoperatively after the first or second day and were called to policlinic three days postoperatively for wound dressing. Patients in both groups regularly visited in policlinic every three days until the wound was totally closed. In the DSD group, wounds were washed with 0.9 % saline and covered with dry sponges as routinely applied in our clinic. In the SIHD group, after washing, silver-impregnated dressings** were placed in the wounds. The dressing procedures were done until the wounds closed completely. During the operation, and at each visit, the wound cavity volume was measured. The person undertaking the outcome assessment was not the same doctor who performed the wound dressings. Wound cavities were filled using 0.9 % NaCl with insulin injectors and the volume was measured. Insulin injectors were filled with 1 ml 0.9 % NaCl. Then, saline was injected in to the wound cavity and wound cavity was filled with saline. Sensitivity of the measurement was 100 micro liters according to the insulin injector scale. Numbers of dressings used and time to complete closure were recorded. Data were presented as mean ± SD. Number of dressings used and time to complete closure of the study groups were compared with t test. Cavity volumes of the study groups were compared with repeated measures ANOVA with Bonferroni test. P value <0.05 was considered as significant.

Fig.1 Wound cavity volumes of the groups DSD= dry sponge dressing SIHD= silver-impregnated Hydrofiber® dressing.

and 30. In the study groups, cavity volume significantly decreased after day seven (p<0.05), while cavity volume of the SIHD group was significantly decreased after day three (p<0.05).

Results Three patients were excluded because of lack of followup. There were 20 males and 1 female with a mean age of 23.6 years (18-30 years) in the DSD group and 21 males and 1 female with a mean age of 23. 4 years (18–28 years) in the SIHD group. Table 1 shows numbers of dressings used and time to complete closure of the study groups. Number of dressings used and time to complete closure in the SIHD group were significantly lower than those of the DSD group (p<0.05). Figure 1 shows cavity volume of the study groups during post-op days 1, 3, 7, 14, 21, 24, 27,

Discussion Most pilonidal sinus cases need surgical intervention. Surgical treatment of this disease can be carried out in three different ways: first, sinus excision and primary closure; second, sinus excision or unroofing and marsupialization; and third, sinus excision and closure by flap. The authors concluded that no clear benefit was shown for surgical management by primary closure or open healing by secondary intention.1,2 Tejirian et al3 recently demonstrated that wide local excision carries a high complication and re-operative rate. They concluded that unroofing and marsupialization should be considered as the initial operation for most patients with pilonidal disease.3 Open techniques and closed techniques have both advantages and disadvantages. Dressing requirements, long closure time of the wound, and long time out of work period are disadvantages of the open techniques. However, lower recurrence rates are also associated with open techniques. Different types of dressing materials have been used to reduce the closure time in open wounds for many years. Polymer films and foams, hydro gels, hydrocolloids, dressings incorporating the technology*, and alginates are commonly used occlusive dressing materials today.4 The silver antimicrobial activity is equivalent to other silvercontaining compounds. The properties of the dressing* allow it to become adherent to the wound within 24 hours. Furthermore, this dressing can be left on a wound for up to two weeks without being removed.5,6

** Hydrofiber, (AQUACEL® Ag, ConvaTec Inc.)

* Hydrofiber®

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2010 vol 10 no 3

Silent. Gentle. Powerful. The complete solution for the sensor-controlled wound drainage.

In this study, silver-impregnated dressings* were used in patients with pilonidal sinus disease to decrease closure time. We found that when the marsupialized pilonidal sinus wounds were treated with silver-impregnated dressings* the closure time was shortened and the number of the dressings required decreased (6.3±1.2 vs 14.8±2). While total closure time was 35.6 ±3.2 days in the DSD group, it was just 27.63±2.8 days in the SIHD group.

Conclusion: This study demonstrates that using silver-impregnated dressings* in wound healing may provide an important advantage for patients who have pilonidal sinus and who were operated on using an open technique. The dressings* seem to accelerate wound healing, especially in wide defects and open technique applied patients, and show an improvement from classical wound care. m References: 1. McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2007;17:CD006213. 2. Huang SH, Wu SH, Sun IF, Lee SS, Lai CS, Lin SD, Lin TM. AQUACEL Ag in the treatment of toxic epidermal necrolysis (TEN). Burns. 2008;34(1);63–66. 3. Tejirian T, Lee JJ, Abbas MA. Is wide local excision for pilonidal disease still justified? Am Surg. 2007;73(10):1075–1078. 4. Helfman T, Ovington L, Falanga V. Occlusive dressings and wound healing. Clin Dermatol.1994;12(3):121-127. 5. Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004; 53(2):132–136. 6. Paddock HN, Fabia R, Giles S, Hayes J, Lowell W, Adams D, Besner GE. A silverimpregnated antimicrobial dressing reduces hospital costs for pediatric burn patients. J Pediatr Surg. 2007; 42(1):211-213.

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2010 vol 10 no 3

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1. White R., Wounds UK 2008; Vol 4, No 1 2. Dykes PJ et al. Journal of Wound Care 2001: 10: 7-10 3. White R. Evidence for atraumatic soft silicone wound dressing use. Wounds UK 2005; 1 (3): 104-109. 3. White R. Evidence for atraumatic soft silicone wound dressing use. Wounds UK 2005; 1 (3): 104-109.

Science, Practice and Education

Venous leg ulcer patients with low ABPIs: how much pressure is safe and tolerable? ABSTRACT Background: Compression devices that deliver high resting pressures are poorly tolerated, causing pain and possibly skin breakdown, especially in patients with concomitant arterial occlusive disease. Aim: To investigate safety, tolerability and some of the physical properties of compression bandages applied to patients with ankle-brachial pressure indices between 0.5 and 0.8. Material and Methods: Eight experienced wound care nurses in Canada and the Netherlands measured sub-bandage pressures in the supine and standing position for each applied compression system to all patients in treatment with ABPIs between 0.5 and 0.8. In addition, data on bandage wear time and adverse events were recorded. Results: The average resting pressure was 24.9 mmHg, the average standing pressure 32.2 mmHg and the average static stiffness index 7.2. There was a strong correlation between resting and standing pressure and between resting pressure and static stiffness index. There was no correlation between resting pressures and anklebrachial pressure indices. Two adverse events were reported, both being on pain in the foot. Conclusions: The applied compression bandages were safe to use and well tolerated by the patients.

Introduction National guidelines, such as those from the Scottish Intercollegiate Guidelines Network, recommend that patients with an Ankle-Brachial Pressure Index (ABPI) or Ankle-Brachial Index (ABI) of less than or equivalent to 0.8 should be assumed to have peripheral vascular disease1. These guidelines, produced through a multidisciplinary structure using formal methods and strict criteria for the evaluation and inclusion of evidence, are widely regarded as the ‘gold’ standard’2. In addition, a confusing variety of recommendations for treatment of patients with mixed arterio-venous disease can be found. To date there is almost no information on the actual sub-bandage pressures provided to patients with venous leg ulcers and ABPIs between 0.5 and 0.8. As a consequence, there is a lack of information on the physical properties of the applied materials.

Jan Schuren, RN, BN, MSc1 Annelies Vos, RN2 Jill O. Allen, RN, WOCN/ET3 1 3M

Deutschland GmbH, Neuss, Germany. 2 3M Nederland BV, Medical Markets, Zoeterwoude, the Netherlands. 3 3M Canada Health Care, London, Canada. Corresponding Author: Jan Schuren, jschuren@mmm.com Conflicts of interest: All three authors are employed by 3M Company. 3M provided the participating centres the PicoPress devices needed for the pressure measurements.

Aim To get a better understanding of the safety and tolerability of compression bandages applied to venous leg ulcer patients with low ABPIs as well as some physical properties of the applied bandages. Methods Measuring devices* and data collection forms (figure 1) with written instructions of the measuring procedures (figures 2 and 3) were provided to eight experienced wound care nurses in Canada and the Netherlands. The participating clinicians were asked to measure sub-bandage pressures in the supine and standing position for each applied compression system to all patients in treatment with ABPIs between 0.5 and 0.8.



* PicoPress® (Microlab Elettronica Sas, Italy)

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2010 vol 10 no 3

Figure 1: the data collection form

Figure 2: the sensor is positioned at â&#x20AC;&#x153;B1â&#x20AC;?; this is the area at which the Achilles tendon changes into the calf muscles (approximately 10-15 cm proximal to the medial malleolus).

As a consequence, data from several applications to the same patient can be included in the analysis. In addition, wear time and adverse events were recorded. The clinicians were instructed to use their routine technique and have the application not influenced by the measurements. The software program** was used for statistical analysis and to create the graphs. Data collection is ongoing; an interim analysis was performed on the first 140 applications.

Results The participating centres returned questionnaires on 140 applications on 86 patients. A variety of materials were applied, most were short stretch systems, typically combined with padding materials or with the comment that bandages were applied at less than full stretch. Several multi-layer systems were reported as well as modifications thereof. Because of the use of many techniques and modifications, it was impossible to analyse each of them individually. The mean age of the patients was 70.0 years (range 50-101). The average ABPI of the patients was 0.68 (range 0.5-0.79). Of the 140 applications, 37 bandages were applied to 16 patients with an ABPI between 0.5 and 0.59; 23 bandages to 22 patients with an ABPI between 0.6 and 0.69 and 80 bandages were applied to 48 patients with ABPIs between 0.7 and 0.8. The average wear time was 3.7 days (range 1-7). The average resting pressure was 24.9 mmHg (range 6-40), the average standing pressure 32.2 mmHg (range 6-52) and the average static stiffness index 7.2 (range 0-14). These data are graphically displayed in figures 4abc and 5. There was a strong correlation between

Figure 3: during the measurement of the resting pressure, the foot rests relaxed on the bed, the knee is slightly flexed and the calf is completely free of the bed surface.

resting and standing pressure (p = <0.001, Pearson r = 0.92, figure 6) and between resting pressure and static stiffness index (p = 0.001, Pearson r = 0.27, figure 7). It was observed that each mmHg increase of resting pressure resulted in a 1.2 mmHg increase of standing pressure. There was no significant correlation between resting pressure and ABPI (p = <0.63, Pearson r = -0.04, figure 8). Two adverse events were reported, both being pain in the foot. For one patient (age: 67, ABPI: 0.76, resting pressure: 40 mmHg) additional padding was used in subsequent applications. The other patient (age: 52, ABPI: 0.71, resting pressure: 26 mmHg) was referred to a vascular surgeon and compression therapy was discontinued.

** MinitabÂŽ 15.1 (Minitab Inc, State College PA, USA)

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2010 vol 10 no 3

Science, Practice and Education Figure 4abc: boxplots of age, abpi and days in place; the diamonds represent the mean values.

Figure 5: boxplots of resting and standing pressure and ssi; the diamonds represent the mean values.

Figure 6: fitted line plot of resting and standing pressure (p = <0.001, Pearson r = 0.92).

Discussion One of the simplest and most useful parameters to objectively assess lower extremity arterial perfusion is the ABPI, which helps to successfully screen for severity of the peripheral arterial disease. In a consensus statement of the Society of Interventional Radiology3 it is stated that ABPIs as high as 1.10 are considered normal; abnormal values are those less than 1.0; that the majority of patients with claudication have ABPIs ranging from 0.3 to 0.9; that rest pain or severe occlusive disease typically occurs with an ABPI lower than 0.50 and that indices lower than 0.20 are associated with ischemic or gangrenous extremities. Caruana et al4 summarised what is known about ABPIs and concluded that in particular, care needs to be taken with methodology and training, reproducibility, interpretation, clinical recording and scientific reporting. Mixed arterio-venous disease is present in a large percentage of patients with ulcerated legs. In 1985, Cornwall et al5 reported 22%, and others present similar numbers: 1987, Callam et al6 21%; 1993, Anderson et al7 at least 20%; 1994, NelzĂŠn et al8 22%; 1998, Morrell et al9 23%. In 1999, Zimmet10 stated that arterial insufficiency may co-exist in up to one-third of venous ulcer patients. In spite of decades of continuous attention, there is still a dearth of

Figure 7: fitted line plot of resting pressure and static Âstiffness index (p = 0.001, Pearson r = 0.27).

Figure 8: fitted line plot of resting pressure and abpi (p = <0.63, Pearson r = -0.04).

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hard data to support evidence-based clinical decisions on the use of compression therapy for these patients. Anklebrachial pressure index (ABPI) or ankle-brachial index (ABI) of less than 0.8 is a listed exclusion criteria in almost every published clinical study on venous leg ulceration. In the listed exclusion criteria in almost every published clinical study on venous leg ulceration is an ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) of less than 0.8. Published guidelines for conducting studies to assess the efficacy of compression in venous disease, state that asymptomatic and symptomatic peripheral occlusive arterial disease with an ankle/arm index <0.8, may be carefully considered as an exclusion criterion11. A recent Cochrane review by O’Meara et al12 on the treatment of venous leg ulcers revealed that in only four of 39 studies that were included in the review, did not exclude an ABPI of less than 0.8. In these four studies however, arterial disease was listed in the exclusion criteria12. In the ESCHAR study, a large randomised controlled multi-centre trial in the UK, 276 of 1418 patients (19.5%) were excluded because of an ABPI < 0.8513. Similar numbers can be found in many other trials: e.g. Morrell et al14, in which 93 of 393 patients (23.7%) were excluded because of an ABPI < 0.8. In addition, a confusing variety of recommendations for treatment of patients with mixed arterio-venous disease can be found. In 2006 Grey et al15 stated that patients may have a combination of venous and arterial diseases, resulting in ulcers of mixed aetiologies, which will limit the degree of compression (if any) that can be used. In the above mentioned Cochrane review, the ABPI cut-off point for application of compression was 0.8 in the majority of the included studies (23/33), other values being 0.7 and 0.75 in one trial each, 0.9 in seven trials and 1.0 in one trial12. Clinical practice guidelines published by the Royal College of Nursing comment that although the cut-off point below which compression is not recommended is often quoted as 0.8, vascular surgeons may use a lower cut-off point, for example 0.6 or 0.716. The International Leg Ulcer Advisory Board recommends that patients with arterial insufficiency (ABPI 0.5-0.8) can be treated with reduced compression (15-25 mmHg)17. The World Union of Wound Healing Societies consensus document on compression in venous leg ulcers, recommends mild to moderate compression for these patients using inelastic bandages with extra padding. They remark that in some countries mild to moderate elastic bandages may be used with caution for certain patients18. Valencia et al19 suggest that compression therapy is contraindicated in patients with a low ABPI. Reichenberg et al20 recommend avoiding compression below an ABPI of 0.7. Kunimoto21 states that long-stretch bandages are relatively safe in the presence of moderate arterial insufficiency, that they may be used if the

ABI is greater than 0.5 and require only a minor degree of training. On the contrary, Sackheim et al22 suggest that for patients with arterial insufficiency, such as those with an ankle brachial pressure index ≤ 0.9, compression bandages should be modified and that inelastic compression may be preferred. In literature, evidence can be found that mixed venous/ arterial leg ulcers heal with compression therapy. However, in the studies that report healing data, no subbandage pressure measurements were performed on the patients.23-28 Bolton29 concludes that further research is needed to identify appropriate level(s) of compression to optimise clinical outcomes for venous leg ulcer patients with varying degrees of ischaemia. In addition to the exerted resting pressure of a bandage, the textile elastic property of its material is of decisive importance for the efficacy of compression treatment30. The increase in pressure (measured in the gaiter area) when standing up from the supine position is defined as the static stiffness index (SSI). A consensus document to define the deciding characteristics of a compression bandage recently suggested that a pressure increase of more than 10 mmHg (SSI >10) is characteristic of a stiff bandage system31. In this study it became obvious that the majority of the applied bandages could not be characterised as a stiff bandaging system (SSI > 10). Only 41 of 140 applications (29.3%) reached a SSI of 10 or higher, 60 applications (42.8%) reached a value of 5 or below. Mosti et al32 demonstrated that there was a strong correlation between the SSI on one side and an improvement of venous pumping function as reflected by ejection fraction (EF) on the other. In a more recent study, Mosti et al33 showed that a significant improvement in venous pumping function (i.e. EF) was achieved with inelastic bandages even at resting pressures of 20 mmHg, provided by a system with sufficient stiffness. This observation leads to the suggestion that still much can be improved in this field. Patients with low ABPIs, for which the common belief is that they cannot tolerate routinely applied sub-bandage pressures, might benefit from effective compression. This observational study also revealed that there is a significant correlation between the provided resting pressures and the SSIs: the lower the resting pressure, the lower the SSI. The most important finding of this observational study is that a wide range of sub-bandage pressure values (between 6 and 40 mmHg) has been safely applied by experienced nurses to patients with an ABPI between 0.5 and 0.8. These pressure values were well tolerated and the applied 

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2010 vol 10 no 3

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Science, Practice and Education

compression systems were left in place over longer periods (up to seven days). Before this study started, the participating nurses did not measure pressure after application, but always applied their compression systems based on their experiences with these patients at risk. They were taught to observe clinical signs of under-perfusion and modify existing techniques to their individual needs. Now that the actual pressures of these modifications in this study are revealed, there is a conflict between the observation and what we have been taught and believe. A large number of the applied compression systems provided resting pressures between 30 and 40 mmHg (49 of 140, 35%), a range contraindicated by many authors and guidelines. In this study there was no relationship between provided resting pressures and ABPI. This implies that also patients in the lower ABPI range (0.5-0.6) were treated with these pressures without clinical signs of complications. Caruana et al4 state that the apparent simplicity of the ABPI may beguile the unwary and that absolute pressures are probably more valuable in patients with critical limb ischaemia. After the results of this study were presented34, References 1. SIGN. The care of patients with chronic leg ulcer: a national clinical guideline. Scottish Intercollegiate Guidelines Network, Edinburgh, 1998. 2. Coull A, Tolson D, McIntosh J. Class-3c compression bandaging for venous ulcers: comparison of spiral and figure-of-eight techniques. J Adv Nursing 2006; 54: 274-283. 3. Sacks D, Bakal CW, MD, Beatty PT, Becker GJ, Cardella JF, Raabe RR, Wiener HW, Lewis CA. Position statement on the use of the ankle brachial index in the evaluation of patients with peripheral vascular disease: a consensus statement developed by the standards division of the society of interventional radiology. J Vasc Interv Radiol 2003; 14: S389. 4. Caruana MF, Bradbury AW, Adam DJ. The validity, reliability, reproducibility and extended utility of ankle to brachial pressure index in current vascular surgical practice. Eur J Vasc Endovasc Surg 2005; 29: 443-451. 5. Cornwall JV, Doré CJ, Lewis JD. Leg ulcers: epidemiology and aetiology. Br J Surg 1986; 73: 693-696. 6. Callam MJ, Harper DR, Dale JJ, Ruckley CV. Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study. BMJ 1987; 294: 929-931. 7. Andersson E, Hansson C, Swanbeck G. Leg and foot ulcer prevalence and investigation of the peripheral arterial and venous circulation in a randomised elderly population: an epidemiological survey and clinical investigation. Acta Derm Venereol 1993; 73: 57-61. 8. Nelzén O, Bergqvist D, Lindhagen A. Venous and non-venous leg ulcers: clinical history and appearance in a population study. Br J Surg 1994; 81: 182-187. 9. Morrell CJ, Walters SJ, Dixon S, Collins KA, Brereton LM, Peters J, Brooker CG. Cost effectiveness of community leg ulcer clinics: randomised controlled trial. BMJ 1998; 316: 1487-1491. 10. Zimmet SE. Venous leg ulcers: modern evaluation and management. Dermatol Surg 1999; 25: 236-241. 11. Rabe E, Partsch H, Jünger M, Abel M, Achhammer I, Becker F, Cornu-Thenard A, Flour M, Hutchinson J, Issberner K, Moffatt Ch, Pannier F. Guidelines for clinical studies with compression devices in patients with venous disorders of the lower limb. Eur J Vasc Endovasc Surg 2008; 35: 494-500. 12. O’Meara S, Cullum NA, Nelson EA. Compression for venous leg ulcers. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD000265. DOI: 1 0.1002/14651858.CD000265.pub2. 13. Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ 2007; 335: 83. Epub 2007 Jun 1. 14. Morrell CJ, Walters SJ, Dixon S, Collins KA, Brereton LML, Peters J, Brooker CGD. Cost effectiveness of community leg ulcer clinics: randomised controlled trial. BMJ 1998; 316: 1487-1491. 15. Grey JE, Enoch S, Harding KG. ABC of wound healing: venous and arterial leg ulcers. BMJ 2006; 332: 347-350.

this observation was also the main point of criticism in the discussion. As a result, the questionnaire was changed and in future data collection, absolute values on ankle pressure will also be reported and analysed. The ideal compression system is one that combines a low, tolerable resting pressure with an effective SSI. Patients with low ABPIs would especially benefit from this combination. Recent developments in this area require further research to document the effects of eventual improvements on oedema reduction and ulcer healing.

Conclusion The results of this observational study so far reveal that the majority of the patients with ABPIs between 0.5 and 0.8 tolerated a variety of applied resting pressures, even at levels that are regarded as critical and that the applied materials were safe to use. The results also revealed that, with the compression bandaging materials that were used, there is a significant correlation between the observed resting pressure and the SSI. m 16. Royal College of Nursing. The nursing management of patients with venous leg ulcers: recommendations. London: Royal College of Nursing, 2006. 17. Stacey M, Falanga V, Marston W, Moffatt C, Phillips T, Sibbald RG, Vanscheidt W, Lindholm C. The use of compression therapy in the treatment of venous leg ulcers: a recommended management pathway. EWMA Journal 2002; 2: 9-13. 18. World Union of Wound Healing Societies (WUWHS). Principles of best practice: Compression in venous leg ulcers: a consensus document. London: MEP Ltd, 2008. 19. Valencia IC, Falabella A, Kirsner RS, Eaglstein WH. Chronic venous insufficiency and venous leg ulceration. J Am Acad Dermatol 2001; 44: 401-421. 20. Reichenberg J, Davis M. Venous Ulcers. Semin Cutan Med Surg 2005; 24: 216-226. 21. Kunimoto BT. Management and prevention of venous leg ulcers: a literature-guided approach. Ostomy Wound Manage 2001; 47: 36-49. 22. Sackheim K, De Araujo TS, Kirsner RS. Compression modalities and dressings: their use in venous ulcers. Dermatol Ther 2006; 19: 338-47. 23. Moffatt CJ, Franks PJ, Oldroyd M, Bosanquet N, Brown P, Greenhalgh RM, McCollum CN. Community clinics for leg ulcers and impact on healing. BMJ 1992; 305: 1389-1392. 24. Ghauri ASK, Nyamekye I, Grabs AJ, Farndon JR, Poskit KR. The diagnosis and management of mixed arterial/venous leg ulcers in community-based clinics. Eur J Vas Endovasc Surg 1998; 16: 350-355. 25. Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999; 30: 491-498. 26. Arthur J, Lewis P. When is reduced-compression bandaging safe and effective? J Wound Care 2000; 9: 469-471. 27. Humphreys ML, Stewart AH, Gohel MS, Taylor M, Whyman MR, Poskitt KR. Management of mixed arterial and venous leg ulcers. Br J Surg 2007; 94: 11041107. 28. Top S, Arveschough AK, Fogh K. Do short stretch bandages affect distal blood pressure in patients with mixed aetiology leg ulcers? J Wound Care 2009; 18: 439-442. 29. Bolton L. Compression in venous ulcer management. J Wound Ostomy Continence Nurs 2008; 35: 40-49. 30. Partsch H. The static stiffness index: a simple method to assess the elastic property of compression material in vivo. Dermatol Surg 2005; 31: 625-630. 31. Partsch H, Clark M, Mosti G, Steinlechner E, Schuren J, Abel M, Benigni JP, Coleridge-Smith P, Cornu-Thénard A, Flour M, Hutchinson J, Gamble J, Issberner K, Juenger M, Moffatt C, Neumann HA, Rabe E, Uhl JF, Zimmet S. Classification of compression bandages: practical aspects. Dermatol Surg 2008 May; 34: 600-609. 32. Mosti G, Mattaliano V, Partsch H. Inelastic compression increases venous ejection fraction more than elastic bandages in patients with superficial venous reflux. Phlebology 2008; 23: 287-294. 33. Mosti G, Partsch H. Is low compression pressure able to improve venous pumping function in patients with venous insufficiency? Phlebology 2010; 25: 145-150. 34. Schuren J. Venous leg ulcer patients with low ABPI’s: how much pressure is safe and can be tolerated? Proceedings of the 20th Conference of the European Wound Management Association, 2010, May 26-28, Geneva. EWMA; 2010: 41.

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2010 vol 10 no 3

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Science, Practice and Education

Adherence to leg ulcer treatment: Changes associated with a nursing intervention for community care settings

Ann Van Hecke, RN, PhD Maria Grypdonck, RN, PhD, Professor Em. Hilde Beele, MD, PhD, Professor Katrien Vanderwee, RN, PhD, Assistant professor Tom Defloor, RN, PhD Gent University, Gent, Belgium Corresponding author: Ann Van Hecke, Ann.VanHecke@ugent.be Conflict of interest: None

Background Venous leg ulceration is common among patients in community healthcare settings. They have a major impact on healthcare costs and quality of life.1 Compression therapy, leg exercises and leg elevation are recommended in evidence-based guidelines. However, non-adherence frequently occurs.2 Few nursing interventions to enhance adherence to leg ulcer treatment are developed and tested for their effectiveness.3 Aim The aim of this study was to examine changes associated with a nursing intervention to enhance adherence to wearing compression, leg exercises, physical activity and leg elevation from patients’ perspective and exploring its effects. Methods Twenty-six patients with venous leg ulcers received an intervention to enhance adherence to wearing compression, leg exercises, physical activity and leg elevation. Five tissue viability nurses carried out the intervention in individual sessions at home. The intervention consisted of three to five visits over a period of three months. It started with the patient’s narrative of living with a leg ulcer to understand the patient’s viewpoints, needs and perceptions of the leg ulcer. Patients were educated about leg ulcer advice. The intervention consisted of educational, cognitive and behavioural components. A combination of qualitative and quantitative research was used in a pre-test/post-test design. Semi-structured interviews with patients were held after the end of the intervention. Data were also collected by participant observation. Thirtyeight observations of the visits between the patient and the nurse were made. Frequency and duration of wearing compression (diary), exercises and elevation (diary), and activity level (accelerometer), pain (verbal scale) and ulcer size (tracings) were registered. Quantitative data collection took place at baseline, at the end of the intervention and three months later.

Findings Knowledge about leg ulcer advice increased. Performing leg exercises was new for most patients. The relationship between the advice and healing or recurrence remained often unclear. Patients often experienced ‘getting out of the groove’ and looked out onto a ‘new’ perspective in which again healing and/or enhancement of quality of life might be attainable. Some patients regained independence after learning how to apply and remove compression garments themselves. Patients also reported creative strategies to incorporate advice in daily life. More patients performed leg exercises after the intervention (P<0.001) and at followup (P=0.003). The frequency of exercising significantly increased. The duration of daily exercising increased from not exercising to 14 minutes/day after the intervention (P<0.001) and 13 minutes three months later (P=0.003). Step counts did not alter significantly. Patients not elevating the legs at baseline, elevated the legs more and for a longer period of time after the intervention. This effect on leg elevation decreased after three months. No significant increase in hours wearing compression was noticed. Pain intensity decreased significantly in patients with pain. Conclusions The intervention resulted in behavioural change. The perceived associated changes suggest that the intervention holds a promise for current home care. Combining qualitative and quantitative research assisted to determine the possible effects of the intervention, increasing the potential for a meaningful randomised trial in the future. m References 1 Briggs M, Flemming K. Living with leg ulceration: a synthesis of qualitative research. J Adv Nurs 2007: 59(4):319-328. 2 Moffatt C, Kommala D, Dourdin N, Choe Y. Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention of recurrence. Int Wound J 2009: 6(5):386-393. 3 Van Hecke A, Grypdonck M, Defloor T. Interventions to enhance patient compliance with leg ulcer treatment: a review of the literature. J Clin Nurs 2008: 17(1):29-39.

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2010 vol 10 no 3

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A Social Model for Lower Limb Care:

The Lindsay Leg Club Model

Michael Clark, PhD Chief Executive Lindsay Leg Club Foundation Michael.Clark21@ btopenworld.com Conflict of interest: Dr Clark is a consultant for the Lindsay Leg Club Foundation.

Abstract The Lindsay Leg Club model is founded upon people with leg problems ‘owning’ their clinic which is located in a non-medical setting such as a church hall. Lindsay Leg Clubs provide leg ulcer management in a social environment where patients (the members of the Leg Club) are typically treated collectively and where the emphasis is on social interaction, participation, empathy and peer support. Between the 14th July 2003 and the 9th of November 2009 data was recorded for 4171 Lindsay Leg Club members who made 29132 separate visits to their Leg Club. Membership of a Leg Club to receive advice and preventive care to maintain healthy legs (n=1595) was more common than attendance for treatment of an active leg ulcer (n=1193). Many people with lower leg problems made the decision themselves to attend a Leg Club (n=1142) suggesting that there is large unmet need for help with lower leg problems that may not be seen in GP surgeries or by District Nurses. The incorporation of a well-leg programme of care within the Leg Clubs may have helped contribute to the relatively low proportion of members who entered active leg ulcer treatment from attending the well-leg programme (n=140, 16.1%)? Introduction The provision of specialist services within the United Kingdom National Health Service for people with venous leg ulcers is common although the format of these services varies widely.1 In a survey of all vascular surgeons in the UK, Campbell and colleagues identified 111 leg ulcer clinics – mainly based in acute care hospitals (58 clinics, 52%) with only 12 clinics solely based in non-acute care (GP surgeries n=7, community hospitals n=2 or in both n=3). Thirty-one (33%) of the leg ulcer clinics were led by nurses. There is a general belief that the provision of leg ulcer care within a dedicated clinic increases both ulcer healing rate and the patients’ quality of life.2-5 however in a recent ran-

domised controlled trial6 no difference between the healing rates achieved after three months were observed where evidence based protocols delivered by specially trained nurses were provided to individuals either receiving care either at home or in a dedicated clinic. Harrison et al6 reported that after three months treatment 56.7% of subjects allocated to care at home had healed leg ulcers, a similar proportion, 58.3%, healed in the dedicated clinics. This may reflect that it is the organisation of care (in particular staff training and access to standard evidence-based protocols) that may be more important than the location in which the care is delivered. Such an observation, if valid, would have implications for leg ulcer services in the UK. Campbell et al1 noted that in 2005 nurses working in leg ulcer clinics generally received ‘inhouse’ and presumably non-standardised training in both Doppler measurements (52% of clinics) and compression bandages (54% of clinics) and where guidelines were in place (90% and 64% of all nurse- and doctor-led clinics respectively) 85% of these guidelines were developed locally. One further observation within UK leg ulcer clinics was the general lack of audit data to demonstrate the outcomes of the clinic with only 42% of clinics holding a database of patients seen and the outcome of treatment.1 Alternatives to either home- or clinic-based care for leg ulcers are available, one of these is the Lindsay Leg Club model and the outcomes of care achieved are described in this report.

The Lindsay Leg Club Model The Lindsay Leg Club model is founded upon the people with leg problems ‘owning’ their clinic which is located in a non-medical setting such as a community or church hall. Working with their local NHS staff, a Lindsay Leg Club is a unique partnership between the district nursing team and the local community. Lindsay Leg Clubs provide leg ulcer management (along with a ‘well leg’ programme of care for those vulnerable to lower limb

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Background Article

Table 1. Profile of Lindsay Leg Club Members between 2003 and 2009. Member Profile Data missing Age (years, mean (SD)) 72.0 (12.5) 140 Age (minimum, maximum) 21, 108 Gender (M:F) 1396: 2648 127 Reason for joining Leg Club 158 Current leg ulcer 1193 (29.7%) Advice on keeping legs healthy 1164 (29.0%) Care of healthy legs 431 (10.7%) Skin tear/traumatic injury 228 (5.7%) Lower leg pain 143 (3.6%) Eczema 130 (3.2%) Leg oedema/Lymphoedema 99 (2.5%) Other reason 782 (19.5%)

problems) in a social environment, where patients (the members of the Leg Club) are typically treated collectively and where the emphasis is on social interaction, participation, empathy and peer support. This social model for delivering lower leg care may differ from a traditional leg ulcer clinic but the Lindsay Leg Club Model has adopted three elements (staff training, use of evidence-based guidelines and quarterly audit of processes and outcomes) that may predispose towards good clinical outcomes.1,6 Each element (training, protocols and audit) is consistent across all Lindsay Leg Clubs. For example, each Lindsay Leg Club (there are 21 at present in the UK) completes a paperbased series of audit forms for each member – these cover their initial visit to the Club, lower leg assessments including Doppler measurements, treatments allocated, reassessment of the leg at regular intervals and transfers between active treatment and the well-leg programme. Every three months these forms are shared with the Lindsay Leg Club Foundation (a UK registered charity established to further the development of the Lindsay Leg Club model), the data entered into a spreadsheet covering all Lindsay Leg Clubs and any errors or gaps in the data collected reported back to individual Leg Clubs. In early 2010 the Lindsay Leg Club Foundation conducted a review of its audit processes leading to the first analysis of the overall data gathered from each Leg Club.

Lindsay Leg Club audit data 2003-2009. Between the 14th July 2003 and the 9th of November 2009 data was recorded for 4171 Lindsay Leg Club members who made 29132 separate visits to their Leg Club. Table 1 describes the demographic profile of the Leg Club members. While many members were elderly and female, 932 (22.3%) were under 65 years old with the mean age of the ‘younger’ Leg Club Members being 54.4 years (SD

8.9 years). Less than 30% of all members attended their Leg Club due to an active leg ulcer, with almost 40% (n=1595) becoming members to receive advice or care to maintain healthy legs. While members were often referred to a Leg Club by their District Nurse (n=859, 21.4%), their General Practitioner (n=802, 19.9%) or their Practice Nurse (n=610, 15.2%), many members had either taken the decision to become a member themselves (n=1142, 28.4%) or their friends or family had suggested they join the Leg Club (n=280, 6.9%). A further 105 attended after viewing an advertisement for their local Leg Club, while in 156 cases the route through which a member was directed towards a Leg Club was unreported. The audit database compiled from the individual Leg Clubs showed gaps in the available data across all demographic variables with no variable having greater than 4% of its potential cases missing. The presence of missing data is one challenge when working with the retrospective analysis of a large administrative dataset.7 Considering the 1193 members who attended because of the presence of an active leg ulcer, the Leg Club procedures call for a photograph to be taken of the wound however few measurements regarding the size of the encountered leg ulcers were present in the database with wound surface area only being reported for 317 (26.6%) people with leg ulcers. Where leg ulcers were measured, the mean surface area was 4.99cm2 (SD 2.83 cm2) with a size range from 1 to 10 cm2. During care within the Leg Clubs’ 867 members were transferred from active treatment to the well-leg programme while 140 (16.1%) transferred to active treatment from participating in the well-leg programme.

Discussion The Lindsay Leg Club model provides people with lower leg problems with care delivered in a social environment and, as such, differs from the traditional concept of a specialist leg ulcer clinic. Edwards and colleagues8 compared the outcomes of lower leg care delivered either in a Leg Club or through home visits; in a small study of 67 patients – 34 subjects were assigned to a Leg Club with 33 receiving care at home. All subjects received similar 

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Background Article

lower leg compression through the use of inelastic compression bandages. The group allocated to the Leg Club reported improvements in their health-related quality of life, increased morale and self-esteem, improved functional ability and leg ulcer healing and decreased pain compared with those treated at home. Some caution regarding these differences may be required given that the care delivered may not have been identical within the two groups,6 for example different nurses may have delivered care in the two arms of the study. To date no formal comparison has been undertaken between the outcomes of membership of a Lindsay Leg Club and attendance at a specialist leg ulcer clinic. The current analysis of the data gathered within UK Lindsay Leg Clubs has highlighted some surprising trends. Membership of a Leg Club to receive advice and preventive care to maintain healthy legs was more common than attendance for treatment of an active leg ulcer. In the absence of a local Leg Club it is challenging to see where these people would have turned to for advice? Many people with lower leg problems made the decision themselves to attend a Leg Club suggesting that there is large unmet need for help with lower leg problems that may not be seen in GP surgeries or by District Nurses. The incorporation of a well-leg programme of care within the Leg Clubs may have helped contribute to the relatively low proportion of members who entered active leg ulcer treatment from attending the well-leg programme. This final potential trend requires substantiation within a well-designed study of the outcomes of the Lindsay Leg Club model of care. The audit data also indicated where the Leg Clubs could improve upon their recording of the outcomes of the Leg Club members. The gaps in the demographic information collected could be reduced, the presence of large numbers of members where the reason for their attendance was reported as ‘other’ (n=782) should be investigated further to identify whether important referral paths are not being captured. The wound images collected should be processed so that all leg ulcers can be reported by sur-

face area and the point of healing correctly identified. The absence of health-related quality of life data captured from all members along with member and staff satisfaction with the Leg Club ‘experience’ should also be corrected. Through such changes the Lindsay Leg Clubs will enhance their data collection procedures allowing future robust analysis of the outcomes of this model of care. m

Implications for Clinical Practice n Lindsay Leg Clubs offer leg ulcer treatment, advice and care for healthy legs within a social environment. n Self-referral to a Lindsay Leg Club is common and may indicate a wide unmet need for lower leg care. Implications for Research n Formal comparison between Lindsay Leg Clubs and Leg Ulcer clinics is required to assess their relative benefits n Trends in the outcomes of care delivered in Leg Ulcer clinics and Leg Clubs could be monitored through audit databases.

References 1. Campbell WB, Thomson H, MacIntyre JB, Coward C, Michaels JA. Venous ulcer services in the United Kingdom. Eur J Vasc Endovasc Surg. 2005, 30: 437-440. 2. Moffatt CJ, Franks PJ, Oldroyd M, Bosanquet N, Brown P, Greenhalgh RM et al. Community clinics for leg ulcers and impact on healing. BMJ 1992;305:1389–1392. 3. Franks PF, Moffatt CJ, Connolly M, Bosanquet N, Oldroyd M, Greenhalgh RM et al. Community leg ulcer clinics: Effect on quality of life. Phlebology 1994;9:83–86. 4 Ghauri ASK, Nyamekye I, Grabs AJ, Farndon JR, Whyman MR, Poskitt KR. Influence of a specialised leg ulcer service and venous surgery on the outcome of venous leg ulcers. Eur J Vasc Endovasc Surg 1998;16:238–244. 5 Morrell CJ, Walters SJ, Dixon S, Collins KA, Brereton LML, Peters J et al. Cost effectiveness of community leg ulcer clinics: Randomised controlled trial. BMJ 1998;316:1487–1491. 6. Harrison MB, Graham ID, Lorimer K, VandenKerkhof E, Buchanan M, Wells PS et al. Nurse clinic versus home delivery of evidence-based community leg ulcer care: A randomised health services trial. BMC Health Services Research. 2008, 8: 243. 7. Black N, Barker M, Payne M. Cross sectional survey of multicentre clinical databases in the United Kingdom. BMJ. 2004,328:1478. 8. Edwards H, Courtney M, Finlayson K, Shuter P, Lindsay E. A randomised controlled trial of a community nursing intervention: improved quality of life and healing for clients with chronic leg ulcers. 2009. J Clin Nurs. 18(11): 1541-9.

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2010 vol 10 no 3

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ABSTRACTS OF RECENT COCHRANE REVIEWS Publication in The Cochrane Library Issue 5, 2010

Staples versus sutures for closing leg wounds after vein graft harvesting for coronary artery bypass surgery

Sally Bell-Syer, MSc Review Group Co-ordinator Cochrane Wounds Group Department of Health Sciences University of York United Kingdom sembs1@york.ac.uk Conflict of interest: none

Fausto Biancari, Valentina Tiozzo Citation example: Biancari F, Tiozzo V. Staples versus sutures for closing leg wounds after vein graft harvesting for coronary artery bypass surgery. Cochrane Database of Systematic Reviews 2010 , Issue 6 . Art. No.: CD008057. DOI: 10.1002/14651858.CD008057 Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background: Surgical site infection (SSI) after saphenous vein graft harvesting is a complication occurring in up to 18% of patients who undergo coronary artery bypass surgery (CABG). It is not known whether the method of skin closure influences the infection rate. Objectives: To compare the rates of SSI and wound dehiscence of staples and sutures for skin closure after saphenous vein graft harvesting for CABG. Search strategy: We searched the following electronic databases: The Cochrane Wounds Group Specialised Register (searched 11/3/10); The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library 2010 Issue 1; Ovid MEDLINE - 1950 to March Week 1 2010; Ovid MEDLINE - In-Process & Other Non-Indexed Citations (Searched 11/3/10); Ovid EMBASE - 1980 to 2010 Week 09 and EBSCO CINAHL - 1982 to March 11 2010. No date or language restrictions were applied. Selection criteria: Trials comparing staples and sutures for closing leg wounds after vein graft harvesting in patients undergoing CABG were eligible for inclusion in this review. Data collection and analysis: Two review authors independently assessed the titles and abstracts of references identified by the search strategy against the selection criteria and extracted data from eligible trials. Included trials were assessed for the following risks of bias: generation of random allocation sequence, allocation concealment, blinding, incomplete outcome data, selective reporting and freedom from other biases. For dichotomous variables, we calculated the relative risk with 95% confidence intervals (CI).

closed with staples and 175 with sutures after vein graft harvesting in patients undergoing CABG. All trials were of sub-optimal methodological quality and all trials were at risk of bias. Leg wound infection rate was 10.8% (16/148) after leg wound closure with staples compared with 8% (14/174) with sutures (relative risk 1.20, 95% CI 0.60 to 2.39). Leg wound dehiscence occurred in 9.3% (10/108) of patients after leg wound closure with staples compared with 8.8% (12/137) with sutures (relative risk 1.05, 95%CI 0.43 to 2.53). Authors’ conclusions: These results suggest that there is no evidence of a difference in the risk of SSI and wound dehiscence when staples rather than sutures are used to close leg wounds after vein graft harvesting during CABG, however more research is needed. Plain language summary Staples versus sutures for closing leg wounds after vein graft harvesting for coronary artery bypass surgery Surgical wounds are usually closed by using either an interrupted or continuous suture using absorbable or non absorbable suture materials. Skin staples are an alternative to sutures and are usually used at the discretion of the surgeon. Skin wound closure with metallic clips is considered to be a fast and effective alternative to sutures. Furthermore, it is commonly believed that staples are less traumatic and may reduce wound complications. This makes the use of staples attractive as it may reduce the risk of postoperative wound complications. Surgical site infection (SSI) after saphenous vein graft harvesting is a postoperative complication that may occur in up to 18% of patients who undergo coronary artery bypass surgery (CABG). We considered the effects of using either staples or sutures for closing the skin after saphenous vein graft harvesting for CABG on rates of wound infection and wound dehiscence. We included four studies reporting on a total of 148 leg wounds closed with staples and 174 with sutures after vein graft harvesting in patients undergoing isolated CABG. There was no difference in leg wound infection rate or in leg wound dehiscence when wounds were closed with staples rather than with sutures.

Main results: We included three prospective, randomised studies reporting on a total of 148 leg wounds 42

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EBWM

This is an update of the review:

Tissue adhesives for closure of surgical incisions Citation example: Coulthard P, Esposito M, Worthington HV, van der Elst M, van Waes OJ F, Darcey J. Tissue adhesives for closure of surgical incisions. Cochrane Database of Systematic Reviews 2010 , Issue 6 . Art. No.: CD004287. DOI: 10.1002/14651858.CD004287.pub2 . Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background: Sutures, staples and adhesive tapes are the traditional methods of wound closure, whilst tissue adhesives have entered clinical practice more recently. Closure of wounds with sutures enables meticulous closure, but they may show tissue reactivity and can require removal. Tissue adhesives offer the advantages of no risk of needlestick injury and no requirement to remove sutures later. Tissue adhesives have been used primarily in emergency rooms but this review looks at the use of tissue adhesives in the operating room where surgeons are increasingly using these for the closure of surgical skin incisions. Objectives: To determine the relative effects of various tissue adhesives and conventional skin closure techniques on the healing of surgical wounds. Search strategy: For this update we searched the Cochrane Wounds Group Specialised Register (Searched 17/11/09); The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library Issue 4 2009; Ovid MEDLINE - 1950 to November Week 1 2009; Ovid EMBASE - 1980 to 2009 Week 46; EBSCO CINAHL - 1982 to 17 November 20098. No date or language restrictions were applied. Selection criteria: Only randomised controlled clinical trials were eligible for inclusion. Data collection and analysis: Screening of eligible studies and data extraction were conducted independently and in triplicate whilst assessment of the methodological quality of the trials was conducted independently and in duplicate. Results were expressed as random effects models using mean difference for continuous outcomes and relative risks with 95% confidence intervals for dichotomous outcomes. Heterogeneity was investigated including both clinical and methodological factors. Main results: This update identified an additional six trials resulting in a total of fourteen RCTs (1152 patients) which met the inclusion criteria. Sutures were significantly better than tissue adhesives for minimising dehiscence (10 trials). Sutures were also found to be significantly faster to use. For all other analyses of infection, patient and operator satisfaction and cost there was no significant difference between sutures and tissue adhesives. No differences were found between tissue adhesives and tapes (2 trials) for minimising dehiscence, infection, patients assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However a statistically significant difference in favour of using tape was found for surgeons’ assessment of cosmetic appearance (mean difference 13, 95% CI 5 to 21). Tapes were also demonstrated to be significantly faster to use than tissue adhesives as were staples (1 trial). No other outcome measures were analysed in this group. One trial compared tissue

adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. In this same trial tissue adhesives were significantly less time consuming to use. For the remaining outcomes of dehiscence and infection no difference was observed between groups. This trial also compared high viscosity with low viscosity adhesives and found that high viscosity adhesives were less time consuming to use than low viscosity tissue adhesives. For all other outcomes of dehiscence, infection, patient satisfaction and operator satisfaction there was no statistically significant difference between high and low viscosity adhesives. Authors’ conclusions: Sutures were significantly better than tissue adhesives for minimising dehiscence and were found to be significantly faster to use. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating theatre they must be aware that adhesives may take more time to apply and that if higher tension is needed upon an incision, sutures may minimise dehiscence. There is a need for more well designed randomised controlled trials comparing tissue adhesives and alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension. Plain language summary Tissue adhesives for closure of surgical skin incisions Tissue adhesives or glues are increasingly used in place of sutures (stitches) or staples to close wounds and it has been suggested that they may be quicker and easier to use than sutures for closing surgical wounds. Adhesives carry no risk of sharps injury and are thought to provide a barrier to infection that also promotes healing as well as do away with the need for suture removal. Fourteen studies were included and for most outcomes assessed there was no difference between tissue adhesives and the alternatives. However fewer wounds broke down when stitches were used and tissue adhesives were more time consuming to use than other methods. Some surgeons and patients preferred the alternatives to tissue adhesives.

This is an update of the review:

Patient education for preventing diabetic foot ulceration Citation example: Dorresteijn JAN, Kriegsman DMW, Assendelft WJJ, Valk GD. Patient education for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD001488. DOI: 10.1002/14651858. CD001488.pub2. Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. Objectives: To assess the effects of patient education on the prevention of foot ulcers in patients with diabetes mellitus. Search methods: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register (22 Decem

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ber 2009), the Cochrane Central Register of Controlled Trials (Cochrane Library 2009 Issue 4 ), Ovid MEDLINE (1950 to November Week 3 2009), Ovid MEDLINE In-Process & Other Non-Indexed Citations (Searched 22/12/09), Ovid EMBASE (1980 to 2009 Week 51) and EBSCO CINAHL (1982 to December 22 2009). Selection criteria: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for preventing foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. Data collection and analysis: Two review authors independently undertook data extraction and assessment of risk of bias. Primary end-points were foot ulceration or ulcer recurrence and amputation. Results: Eleven RCTs were included. Three studies described the effect of foot care education as part of general diabetes education compared with usual care. Two studies examined the effect of foot care education tailored to educational needs compared with no intervention. Finally, six studies described the effect of intensive compared with brief educational interventions. Pooling of outcome data was precluded by marked, mainly clinical, heterogeneity. Four RCTs assessed the effect of patient education on primary end-points: foot ulceration and amputations. One of these studies reported a statistically significant benefit of one hour group education after one year of follow-up in people with diabetes who were at high risk for foot ulceration; RR amputation 0.33 (95% CI 0.15 to 0.76); RR ulceration 0.31 (95% CI 0.14 to 0.66), however this study was at high risk of bias and may have overestimated the effect due to a unit of analysis error. One similar, but methodologically superior study did not confirm this finding; RR amputation 0.98 (95% CI 0.41 to 2.34); RR ulceration 1.00 (95% CI 0.70 to 1.44). The other two studies did not detect any effect of education on ulcer incidence or amputation but were underpowered. Patients’ foot care knowledge was improved in the short term in five of eight RCTs in which this outcome was assessed, as was patients’ self reported self care behaviour in the short term in seven of nine RCTs. The effects on callus, nail problems and fungal infections were described in five of the included studies, of which only two reported temporary improvements after an educational intervention. Only one of the included RCTs was considered to be at low risk of bias. Authors’ conclusions: Most of the RCTs included in this review are at high or unclear risk of bias. In some trials, foot care knowledge and self reported patient behaviour seem to be positively influenced by education in the short term. This, however, must be viewed with caution. The ultimate goal of educational interventions is preventing foot ulceration and amputation but only four RCTs reported these outcomes and only two reported sufficient data to examine this. Based on these two studies, we conclude that there is insufficient robust evidence that limited patient education alone is effective in achieving clinically relevant reductions in ulcer and amputation incidence. Future research should focus on evaluating the effect of more comprehensive and/or intensive prevention strategies which may also include patient education (complex interventions).

Plain language summary Educating people with diabetes about foot care to help reduce foot ulcers and amputations Foot ulcers (open sores) are common in people with diabetes, especially those with problems in the nerves (peripheral neuropathy) and/or the blood supply to their legs (peripheral vascular disease). People with ulcers due to diabetes sometimes need an amputation (surgical removal of part of the limb). Foot ulcers not only lead to physical disability and loss of quality of life but also to economic burden (health care costs, industrial disability). The aim is therefore to prevent foot ulcers occurring. This review of high level studies found that educating people with diabetes about the need to look after their feet seems to improve people’s foot care knowledge and behaviour in the short term. There is insufficient evidence that education alone, without any additional preventive measures, will effectively reduce the occurrence of ulcers and amputations.

Publication in The Cochrane Library Issue 6, 2010

Therapeutic ultrasound for venous leg ulcers Nicky A Cullum, Deyaa Al-Kurdi, Sally EM Bell-Syer. Citation example: Cullum NA, Al-Kurdi D, Bell-Syer SEM. Therapeutic ultrasound for venous leg ulcers. Cochrane Database of Systematic Reviews 2008 , Issue 1 . Art. No.: CD001180. DOI: 10.1002/14651858.CD001180.pub2 . Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. This is an updated review for which there have been new searches and new trials added to the review. ABSTRACT Background: Venous leg ulcers pose a significant burden for patients and healthcare systems. Ultrasound (US) may be a useful treatment for these ulcers. Objectives: To determine whether US increases the healing of venous leg ulcers. Search strategy: We searched the Cochrane Wounds Group Specialised Register (searched 24 February 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2010); Ovid MEDLINE (1950 to February Week 2 2010); In-Process & Other Non-Indexed Citations (searched 24 February 2010); Ovid EMBASE 1980 to 2010 Week 07; EBSCO CINAHL 1982 to 24 February 2010. Selection criteria: Randomised controlled trials (RCTs) comparing US with no US. Data collection and analysis: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We tried to contact trial authors for missing data. Main results: Eight trials were included; all had unclear, or high, risks of bias, with differences in duration of follow-up, and US regimens. Six trials evaluated high frequency US and five of these reported healing at 7- 8 weeks. Significantly more patients healed with US than without it at 7- 8 weeks (pooled RR 1.4, 95% CI 1.0 to 1.96), but later assessments at 12 weeks showed the increased risk of healing with US was no longer statistically

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significant (pooled RR 1.47, 95% CI 0.99 to 2.20). One poor-quality study of high-frequency US found no evidence of an effect on healing after three weeks’ treatment. Two trials evaluated low frequency US and reported healing at different time points. Both trials reported no evidence of a difference in the proportion of ulcers healed with US compared with no US: both were significantly underpowered. Authors’ conclusions: The trials evaluating US for venous leg ulcers are small, poor-quality and heterogeneous. There is no reliable evidence that US hastens healing of venous ulcers. There is a small amount of weak evidence of increased healing with US, but this requires confirmation in larger, highquality RCTs. There is no evidence of a benefit associated with low frequency US. Plain language summary Ultrasound therapy used for healing venous (varicose) leg ulcers and to improve symptoms Venous leg ulcers are common, especially in the elderly. They are caused by damage or blockages in the veins of the legs, which in turn lead to pooling of blood and increased pressure in these veins. Eventually, these changes can damage the skin and lead to ulcer formation. Compression with stockings or bandages is the most widely used, and acceptable, treatment for venous leg ulcers. Ultrasound has been used as an additional intervention, especially for difficult, longstanding ulcers. The mechanisms by which ultrasound waves interact with healing tissues are not fully understood. We conducted a review to establish whether ultrasound speeds the healing and improve symptoms of venous leg ulcers, and examined all the available evidence from medical trials. This showed that there is no strong evidence that ultrasound hastens ulcer healing. There is, however, some weak evidence from poor-quality research that high-frequency ultrasound may increase the healing of venous leg ulcers. This finding, however, requires confirmation in larger and rigorously conducted medical trials before we can be certain that it is true and can be trusted. There is no evidence that low frequency ultrasound improves the healing of venous leg ulcers. m

22nd Conference of the European Wound Management Association

EWMA 2012 23 -25 May · 2012

ienna · Austria

Organised by the European Wound Management Association in cooperation with: Austrian Wound Association, AWA

WWW.EWMA.ORG

EWMA Journal

Previous Issues

Volume 9, no 2, May 2010 Hyperbaric Oxygen and Wounds: A tale of two enzymes Thomas K. Hunt HBOT in evidence-based wound healing Maarten J. Lubbers Comparative analysis of two types of gelatin microcarrier beads Mohamed A Eldardiri et al. Evidence based guidelines – how to channel relevant k nowledge into the hands of nurses and c arers Susan F. Jørgensen, Rie Nygaard Lack of due diligence in the prophylaxis of pressure ulcers? Dr. Beate Weber, Hans-Joachim Castrup Six prevalence studies for pressure ulcers Snapshots from Danish Hospitals Susan Bermark et al. The Ransart Boot – An offloading device for every type of Diabetic Foot Ulcer? I.J.Dumont et al. The Haitian Earthquake, January 2010 John M Macdonald

International Journals The section on International Journals is part of EWMA’s attempt to exchange information on wound healing in a broad perspective. Italian

A prospective multicenter randomized controlled trial comparing the new 2-component bandage system Coban 2 with a zinc oxide bandage Mosti G., et.al. Evaluation of topical negative pressure wound therapy efficacy with filler gauze for the treatment of skin ulcers in home care assistance Petrella F., et.al. Outpatient management of “hard-to-heal” chronic ulcers with vacuum-assisted-closure therapy Rivolta N., et.al. Evaluation of an equine collagen-based silvercontaining wound dressing spray in the treatment of partial thickness wounds Pensabene L., et.al. English

Systematic review of R epositioning for the Treatment of Pressure Ulcers Zena Moore, Seamus Cowman Analysis of wound care in n ursing care homes as part of a district-wide wound care audit Peter Vowden, Kathryn Vowden Chronic leg ulcers among the Icelandic population Guðbjörg Pálsdóttir, Ásta Thoroddsen Cross-sectional Survey of the O ccurrence of Chronic Wounds within Capital Region in Finland Anita Mäkelä The EWMA Teach the Teacher Project Zena Moore Dutch

The EWMA Journals can be downloaded free of charge from www.ewma.org

Dutch Journal of Woundcare NTVW, vol 5. no 9, 2010 Interview: Dermatologist Erna Sybrandy, Slingeland Hospital Doetinchem, The Netherlands: ‘Multidisciplinary treatment gets Ulcers closed and keeps them closed!’ Interview: Dermatologist Tim Wentel, Catharine Hospital Eindhoven, The Netherlands: ‘Treatment of venous leg ulcers without compression is ineffective’ Translation/abstract: In-vitro Comparison of Antimicrobial Efficacy of Various Wound Dressing Materials Yavuz Basterzi, et.al. Education: Antoinette Brandenburg, trainer Erasmus Care Academy Rotterdam, The Netherlands: ‘Students learn by reflecting’

Finnish

Haava, no. 3, 2010 Hyberbaric oxygen in the treatment of diabetic foot ulcer Jari Suvilehto How to exam a chronic leg ulcer? Anna Hjerppe Chronic wounds in lower extremity – a view of plastic surgeon Susanna Kauhanen Trench warfare and delayed action Tiina Pukki Nutrition – an important part of care of a wound patient at home Aiaiina Eriksson

Volume 9, no 2, May 2009 A simple guide to r andomised control t rials in wound care Carolina D Weller New HydroBalance concept tested in the primary health care sector – an impartial study of the H ydroBalance concept in the community of Sorø in Denmark Rie Nygaard, Susan F. Jørgensen Synthesizing data from q ualitative r esearch Michelle Briggs A methodology for evaluating wound care technologies in the context of treatment and care Patricia R Grocott, Natasha C Campling RUT – a winning concept for both p atients and the health care sector Rut F Öien Opinion Paper: Does wound care r equire an a lternative to the randomised trial to evaluate product effectiveness? Peter Vowden

Advances in Skin & Woundcare, vol. 23, no 10, 2010 www.aswcjournal.com Combining Acoustic Pressure Wound Therapy with Electrical Stimulation for Treatment of Chronic Lower-Extremity Ulcers: A Case Series Jeffrey Lasko, et.al. Iranian Diabetic Foot Research Network Ozra Tabatabaei Malazy, et.al. The Effect of Various Wound Dressings on the Activity of Debriding Enzymes Lei Shi, et.al. Development and Implementation of a Professional Wound Care Training Program for Nurses in Taiwan Hsin C. Tsai,et.al. Diagnosis and Management of Foreign Bodies in the Skin Jill E. Winland-Brown, et.al.

Volume 10, no 1, January 2010

Volume 9, no 3, October 2009 Alcohol-based hand-rub versus t raditional surgical scrub and the risk of surgical site infection Mohammed Y. Al-Naami Woundswest: Identifying the prevalence of wounds within western Australia’s public health system Nick Santamaria, Keryln Carville, Jenny Prentice An exploration of current practice in n ursing documentation of pressure ulcer prevention and management Julie Jordan O Brien Dressings and Topical Agents for T reating Donor Sites of Split-Skin Grafts Sanne Schreuder, et al. The resource impact of wounds on health-care providers in Europe J. Posnett Pressure ulcer audit highlights important gaps in the delivery of preventative care in England and Wales 2005-2008 Jill Buttery, Lyn Phillips

Acta Vulnologica, vol. 8, no 3, 2010 www.vulnologia.it

English

International Journal of Lower Extremity Wounds vol. no, 9, http://ijlew.sagepub.com Emerging Trends in Diabetic Foot Ulcer Management in India Vijay Shukla, et.al. Review: The Obesity-Diabetes Association: What Is Different in Indians? C.S. Yajnik,et.al. Role of Industries in the Care of Diabetic Foot A. Ramachandran, et.al. Epidemiology of Diabetic Foot and Management of Foot Problems in India Vijay Viswanathan The Etiopathogenesis of the Diabetic Foot: An Unrelenting Epidemic Sanjeev Kumar Gupta, et.al. EWMA Journal

2010 vol 10 no 3

EWMA Spanish

Helcos, vol. 21, no. 2, 2010 The tropical ulcers which are upon us M. Gago Fornells, R.F. Garcia Gonzales, M. Rodgiguez Palma, P. Lopez Casanova, J. Verdú Soriano Castilian process of adaptation to the Charing Cross venous ulcer questionnaire (CCVUQ) to measure the relation between quality of life to health in patients with venous ulcers R.V González Consuegra, J. Verdú

English

Sklerotherapie – Sclerotherapy F.X. Breu Foam Sclerotherapy – An update S. Kobus, S. Reich-Schupke, P. Altmeyer, M. Stücker Efficacy of sclerotherapie in relation to the patients age B. Kahle, K. Denk, D. Schliephake, A. Recke Sclerosant foams – Stabilities, physical properties and rheological behavior J.C. Wollmann Articaine pharmacokinetics in tumescent anaesthesia G. Bruning, H. Rasmussen, A. Teichler, T. Standl, I. Moll Diagnosis of heparin-induced delayed type hypersensitivity M. Schindewolf, R. Ludwig, M. Wolter, K. Hardt, R. Kaufmann, E. Lindhoff-Last, W.-H. Boehncke, B. Kahle

International Wound Journal, vol. 7, issue 5, 2010 www.interscience.wiley.com/journal Incidence and risk factors of pressure ulcers in seven neonatal intensive care units in Japan: a multisite prospective cohort study K Fujii, et.al. Amulti-centre, prospective, clinical in-market evaluation to assess the performance of Opsite™ Post-Op Visible dressings G O’Brien,et.al. Keloid explant culture: a model for keloid fibroblasts isolation and cultivation based on the biological differences of its specific regions VM Tucci-Viegas, et.al. Low flow oxygenation of full-excisional skin wounds on diabetic mice improves wound healing by accelerating wound closure and reepithelialization R Asmis, et.al. Medical device related pressure ulcers in hospitalized patients JM Black, et.al. Comparative analysis of two methods for wound bed area measurement S Van Poucke, et.al. The effect and safety after extended use of continuous negative pressure of 75 mmHg over mesh and allodermis graft on open sternal wound from oversized heart transplant in a 3-month-old infant K Nathan Lee, et.al. Single-stage Matriderm® and skin grafting as an alternative reconstruction in high-voltage injuries H Ryssel, et.al. Evaluating antimicrobial efficacy of new commercially available silver dressings MH Cavanagh, et.al. Influence on pressure transduction when using different drainage techniques and wound fillers (foam and gauze) for negative pressure wound therapy M Malmsjö, et.al.

English

Journal of Tissue Viability, vol. 19, no 3, 2010 Evidence in wound prevention and treatment: Are the ‘rules’ too hard? Michael Clark Effects of local cooling on sacral skin perfusion response to pressure: Implications for pressure ulcer prevention Yi-Ting Tzen, et.al. A comparison of Braden Q, Garvin and Glamorgan risk assessment scales in paediatrics Denis Anthony, et.al.i A practice-oriented recommendation for treatment of critically colonised and locally infected wounds using polihexanide J. Dissemond, V. et.al. Tolerability and safety of conventional therapy combination with DeMarco formula for infected ischemic diabetic foot Héctor Álvarez Duarte, et.al.

English

Wound Repair and Regeneration, vol. 18, no 5, 2010 Antiseptic therapy with a polylacticacid – acetic acid matrix in burns Henning Ryssel, et.al. The differential effect of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers with respect to foot ulcer and limb amputation in those with diabetes David J. Margolis, et.al. Regulation of fibroblast gene expression by keratinocytes in organotypic skin culture provides possible mechanisms for the antifibrotic effect of reepithelialization Anita Koskela, et.al. Importance of housekeeping gene selection for accurate reverse transcription-quantitative polymerase chain reaction in a wound healing model Anna Turabelidze, et.al. elayed wound healing in diabetic (db/db) mice with Pseudomonas aeruginosa biofilm challenge: a model for the study of chronic wounds Ge Zhao, et.al. Enhanced healing of mitomycin C-treated healing-impaired wounds in rats with hydrosheets composed of chitin/chitosan, fucoidan, and alginate as wound dressings Kaoru Murakami, et.al. Biomaterials modulate interleukin-8 and other inflammatory proteins during reepithelialization in cutaneous partial-thickness wounds in pigs Kyle R. Kleinbeck, et.al. Nanotechnology promotes the full-thickness diabetic wound healing effect of recombinant human epidermal growth factor in diabetic rats Yuejie Chu, et.al.

German English

Phlebologie, no 4, 2010

Wund Management, vol. 4, no 5, 2010 English abstracts are available from www.mhp-verlag.de Update Diabetic Foot Syndrome 2010: News in Diagnostics and Therapy H. Reike The diabetic foot syndrome from the viewpoint of an interdiscipinary vascular center G. Rümenapf, K. Amendt

Swedish

Tidskriften Sår vol. 4, no 3, 2010 Theme: Complicated wounds Hyperbaric oxygen in the treatment of complicated wounds. Department of Hyperbaric Oxygen, Karolinska University hospital

Journal of Wound Care, vol. 19, no 4, 2010 www.journalofwoundcare.com

Self-inflicted wounds – a review

Flammacérium in the formation and stabilisation of eschar in chronic wounds C. Signe-Picard, M-I. Cerdan, C. naggara, C. Trial, L. Téot. The Leg Club model: a survey of staff and members’ perceptions of this model of care J. Stephen-Haynes Quality of nursing care from the perspective of patients with leg ulcers E. Törnvall and S. Wilhelmsson Ward nurses’ use of wound dressings before and after a bespoke education programme G. Smith, M. Greenwood, R. Searle Transforming growth factor-beta in wound healing: a review

Peristomal pyoderma gangraenosum – a case report

Management of a complex wound in a person with spinal cord injury and mental illness C. Phillips, N. Procter EWMA Journal

2010 vol 10 no 3

Hidradenitis suppurativa – recent research Portrait of a pioneer – Malignant wounds

Scandinavian

Wounds (SÅR) vol. 18, no 3, 2010 www.saar.dk Inflammatory ulcers – an overview Brita Pukstad Home nursing rates in wounds in Holbæk Ulcers in the north – visiting Hjørring Hospital The Capital Region scrap efficient (and cheap) chiropody Feet in a jam – diabetic patients lose grants Jens Fonnesbech Medical students are now examined in diagnosis and treatment of chronic wounds Mikael Henriksen, Mikael Bitsch

The EWMA Patient Outcome Group

Outcomes in controlled and comparative studies on non-healing wounds:

Recommendations to improve the quality of evidence in wound management

F. Gottrup1 MD, DMSci, Professor of Surgery, Chair of the EWMA Patient Outcome Group

Summary1 J. Apelqvist2,3 MD, PhD, Senior Consultant, Associate Professor, Executive member of the EWMA Patient Outcome Group;

P. Price4 PhD, CHPsychol, Dean and Head of School of Healthcare Studies, Executive member of the EWMA Patient Outcome Group;

vidence based clinical practice is difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group whose remit was to produce recommendations on clinical data collection in wound care. The document, produced by the group and published by Journal of Wound Care 1, identifies criteria for producing precise outcomes in both randomised controlled trials and clinical studies, and describes how to ensure studies are consistent and reproducible. This summary gives a short presentation of the content of the full document.

1 Bispebjerg

University Hospital, Copenhagen, Denmark; 2

Malmö University Hospital, Sweden;

University of Lund, Sweden; 4

Cardiff University, UK. Corresponding author: EWMA Organisation, ewma@ewma.org

Conflict of interest: None

Background Non-healing wounds are a significant problem for health-care systems worldwide. In the industrialised world, almost 1-1.5% of the population will have a problem wound at any one time. Furthermore, wound management is expensive: e-g. in Europe the average cost per episode is e 6,650 for leg ulcers and € 10,000 for foot ulcers, which accounts for 2-4% of health-care budgets. 1 The document was published in Journal of Wound Care, Vol. 19, Iss. 6, 6 June 2010, pp 237-268

For these reasons there is an urgent need to review wound strategies and treatments in order to reduce the burden of care in an efficient and cost-effective way. A primary question is which interventions, technologies and dressing materials are the best from those available? Ongoing controversy surrounds the value of various approaches to wound management and care. There is a need to consider alternative ways of achieving the highest level of evidence required for this patient group. Quality of evidence in wound management is especially interesting from the following perspectives: n From the clinical perspective the question is which interventions, technologies and dressing materials are the best from the point of view of a single patient or group of patients, where the primary focus is healing and the absence of complications. Wound management has a paucity of highquality evidence, as studies are often based on inadequate sample sizes, have short follow-up periods, non-random allocation to treatment groups, non-blinded assessment of outcomes, and poorly described control groups and concurrent interventions.

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From the policy maker and health-care system perspectives two issues arise: – Whether or not a particular product or intervention is safe and effective when used as indicated – this is a question of regulatory approval. – Whether or not the product or intervention represents a cost-effective use of funds.

Too few good quality clinical or economic studies in wound care have resulted in challenges to the reimburse ment of modern dressings in favour of supposedly better value traditional products. n

From the industry perspective (medical device industry) the challenge is that the standard of care and evidence requirements for reimbursement may be different in each country and that large investments in evidence are rarely justified by the pace of innovation and size of markets for most wound care products.

The aim of the document is to provide recommendations on how to achieve rigorous endpoints/ outcomes in studies on wound management and to describe an approach that will enable the design of RCTs and clinical studies to be both consistent and reproducible in order to reach a higher quality of evidence in wound management.

Definition of endpoints/outcomes Study endpoints or outcomes are the key stone in the evidence discussion. To clarify the basic premises of the discussion, the terminology needs to be clarified. An endpoint/outcome parameter is defined as the objective of an evaluation or study. The objectives should include: n A precise statement of the degree of benefit expected from the intervention, and its duration n Clear statements on the time frame of the study (especially in relation to how quickly the benefits might start) n A definition of the patients for whom the benefit is sought. In the past, the most commonly used clinical outcome (endpoint that directly relates to outcome) was visible reduction in wound size, particularly intact skin (full healing). The development of tests and techniques to improve tissue sampling and analysis, imaging technology and scientific progress in cellular and molecular biology has ena-

bled the development of more ‘objective’ wound outcome parameters (surrogate outcome parameters) that relate to both the wound condition and the treatment intervention being assessed (for example, exudation rate, pain, granula tion rate, resolution of necrosis or infection). A surrogate endpoint/outcome parameter is defined as a physical sign or a laboratory measurement that can be used as a substitute for a clinically meaningful endpoint, effectively directly measuring how a patient feels, functions or survives. The challenge, in non-healing wounds, is that these types of endpoints/outcome parameters are difficult to achieve and maintain. If the only gold standard was total wound closure, no therapy would ever be considered efficacious. Alternative endpoints are therefore needed.

Material and methods Material: The background information, evaluations and recommendations of the document are based on a collection of a large amount of available guidance for evidence collection and an analysis of recent RCTs and comparative studies. To achieve an updated status (2003-2009) on how endpoints/outcome parameters are used, defined and evaluated, we performed a literature search on chronic/ problem wounds/ulcers, with the objective of examining and registering their use of endpoints, the quality of their endpoint definitions and the robustness of their methodologies. Discussions with various stakeholders within and outside the framework of the EWMA Patient Outcome Group have also provided a basis for the structure and content of the document. Methods: To establish a basis for the recommendations and statements related to study designs and use of outcome measures in wound management, data collection issues, concepts and terms were discussed and used in the document. The challenge has been to control the heterogeneity of individual patients, concurrent disease states and confounding factors, as well as variations in the type, site and condition of wounds and differences in health-care organisations. These problems cannot be solved by enrolling more subjects into a study. Currently, the majority of wound management studies recruit patients with one wound aetiology. However, the development of more targeted strategies specific to dif

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Table 1: Statements on endpoints/outcome parameters Wound closure, defined as total epithelialisation without discharge, is the most important endpoint relating to ulcer healing. It must be confirmed by an independent source (photography) and there must be sufficient follow-up to confirm healing

Wound area reduction is a valid endpoint with regard to wound healing but it must be confirmed by tracing and include a predefined relevant cut-off to ensure that ‘reduction rate error’ (described in section: ‘reduction rate’) does not occur

There is enough evidence to support the use of a 50% reduction in wound surface area over time as a useful outcome, provided that the initial wound size and the measurement technique are taken into consideration. The time interval used in such assessment will vary depending on the wound type. Any reduction of less than 50% cannot be supported by the current literature; in these instances, more objective measures of size reduction must be used

Time to heal is an important outcome. However, the study protocol must consider the substantial methodological difficulties entailed, particularly confirmation of the exact date of healing for each patient during the specified observation period. To date, the accepted time interval for resource studies is one year

There is an urgent need for a validated scoring system with regard to wound condition

When using changes in the wound condition as an outcome parameter, they must be predefined and measured in such a way that they can be validated independently, wherever possible (for instance, by photograph)

When using biological markers as a primary outcome, they should be clearly predefined, and a clinically relevant unit of change should be specified; reliable and valid quantitative assessment methods should be used

When using wound infection as a primary outcome marker, it should be clearly predefined. At present, this could be either a binary measure of presence/absence or a composite score focusing on clinical signs and symptoms

ferent phases of treatment (e.g. debridement) means that the condition of the wound (e.g. exudate rate, pain and necrosis) may be a better inclusion criterion. Furthermore the following perspectives and terms have been taken into consideration: From the clinical research perspective there is a need to be aware of the strengths and limitations of different study designs if they are to effectively evaluate which health-care practices are worth considering for different patients in different health contexts. Key issues are, for example, use of a study protocol, problems related to heterogeneity of the study population and underlying conditions. From an industry perspective, external evidence needs are set by the requirements of national regulatory and 50

Regardless of the assessment tool used, when using pain as an outcome measure it is important to pre-define the amount of wound pain reduction that is clinically important When surrogate parameters such as symptoms and signs, or composite endpoints such as scales, are used as primary endpoints, it is essential that both their basic definition and what is considered to be a clinically relevant difference are predefined. When used as an primary endpoint, it is favourable for it to be verified by an independent evaluator When assessing dressing performance in an objective manner, with a focus on a specific aspect of symptom management, a comparative study may not be needed; the relevant data could be better assessed using a cohort study with a standardised, reproducible and validated protocol that includes resource utilisation (when appropriate) HRQoL assessments must be based on tools with established psychometrics The type of assessment must fit with the purpose of the data collection: if HRQoL data are to be used for health technology assessment reviews, then generic and/or utility methods must be included When cost is used as an outcome parameter in wound management, it is essential to measure all the quantities of resources used and then add the value of those resources, according to a predefined protocol. It is recommended that resource use and cost are shown separately Wherever resources have alternative uses, decisions on the adoption of new technologies or new procedures cannot be made on the basis of clinical outcomes alone. Rational choice requires evidence of the costs and benefits of alternatives In order to maximise the value of investments in clinical research, studies should be designed to address the relative cost-effectiveness of alternatives from the outset, as well as their safety and effectiveness.

reimbursement authorities, and other payers. When developing a new product, there are also internal needs for evidence, which mirror the phases of the development process. When focusing on payment or reimbursement for a new product, the key issue will often be budgetary impact and/or cost-effectiveness, rather than healing. The document also discusses the importance of a generally accepted definition of ‘standard care’ in connection with data collection in wound management. ‘Standard care’ refers to generally accepted wound care procedures and the management of underlying disease, outside of the investigational product/device or drug that will be used in the clinical trial/evaluation. It is essential that the standard care procedures/regimens used are consistent as this will minimise variability and enable assessment of the  treatment effect. EWMA Journal

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Table 2: A list of common methodological errors in wound-dressing trials

Lack of validation of subjective assessments

Lack of description of objective or subjective measures

Lack of comparable baselines for patient groups

Lack of blinding for the evaluation of primary outcomes

Incorrect randomisation methods

Poor definition of primary and secondary objectives

Number of patients not based on a priori sample size calculation

Randomisation method poorly/not described

Assessment of outcomes not completely objective

Time to wound healing not used as primary outcome

Intention-to-treat analysis not used

No use of single reference wounds

Heterogeneous study population

Number of and reason for dropouts not stated

No specification of adjuvant treatments (such as pressure-relieving surfaces or offloading devices for neuropathic ulcers) Small sample size combined with multiple outcome measures Reporting of multiple outcomes over multiple time points (increases chance of type I error) Poor overall study reporting

Results Following an evaluation of abstracts from the recent RCTs and comparative studies by three reviewers, 176 articles found in the literature search were selected for analysis. Many studies measured multiple endpoints/outcome parameters – in total, this analysis generated a list of 313 different endpoints. The endpoints were divided into the following categories (the percentages represent each category’s proportion of the 313 registered endpoints): n Reduction rate (24.1%) n Wound closure (16.9%) n Healing time (9%) n Change in wound condition (9%) n Biomarkers and bacteriology (4.5%) n Circulation (1.9%) n Infection signs (4.5%) n Symptoms and signs (13.2%) n Dressing performance (7.0%) n Quality of life (5.8%) n Costs and resources used (4.5%).

Table 3: Checklist for objectives and outcomes in clinical trials

Are the intervention and control (e.g., usual care) described in detail? Has the target patient population been specified? Has the degree of benefit from the intervention on a particular outcome, and the time frame, been specified? Has the primary outcome, including how and when it is to be measured, been specified? Have any secondary outcomes been pre-specified in similar detail? Outcomes Are the outcomes clinically relevant, objective (wherever feasible) and unambiguous? Can the outcomes be measured for all patients and, where possible, assessed with researchers blinded to the allocated treatment? Is the study explicit in the frequency and duration of outcome measurement? Has the study been specially planned from a statistical viewpoint when multiple outcomes are measured? If the outcome is a surrogate, will it adequately reflect a main outcome, and is there an indication of how much a benefit observed on the surrogate outcome will translate to a benefit on a main outcome?

(Reference: Appendix B, Quality of Literature, ECRI Institute Study Quality Assessment Instrument, Negative Pressure Wound Therapy Devices, www.ecri.org)

The findings of the analysis were used as a basis for discussing and suggesting procedures for the successful measurement of each of the types of endpoint categories defined. In general, it was found that a substantial number of endpoints (45%) were either not predefined or insufficiently defined. As part of the analysis, the degree of robustness of the measurement techniques used in studies2 and the degree of reproducibility3 were evaluated. In 70% of cases, a standardised or clearly defined measurement technique was used to examine the endpoint (e.g. computerised planimetry or a standardised evaluation method). These were defined as meeting the criteria for an acceptable degree of robustness. However, 76% of these did not meet the criteria for reproducibility. The analysis and discussion resulted in a number of recommendations (‘statements’) on use of endpoints in RCTs and comparative studies on non-healing wounds (See table 1).

2 Defined as a level of information about the measurement technique, such that others could replicate the data collection in an identical way. 3 Defined as the inclusion of a verifiable source of data, e.g. photos, to secure the possibility of validation from an external source by reproducing the study, or the involvement of an external validation source as part of the study design.

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Discussion When evaluating interventions in wound management it is a challenge to avoid performance bias. Designing studies with the aim of obtaining sufficient information regarding outcomes is particularly hazardous. The document therefore discusses and provides recommendations regarding some of the considerations that should be made when designing studies on interventions for the treatment of wounds. The definition of non-healing wounds is still discussed. We suggest that the definition ‘chronic’ be replaced with the definition ’non-healing’ as this better reflects the clinical problems experienced by such patients. It is also suggested that multicentre trials should imply great efforts to enrol sufficient numbers at each site and a high degree of protocol standardisation. Another issue brought forward is the selection of an appropriate study period. Recommendations from various institutions vary from 2 weeks to 12 months. We recommend that the type(s) of ulcer and relevant natural outcome is considered when selecting the study duration. Some common methodological errors in wound-dressing studies and a Checklist for objectives and endpoints/ outcomes in clinical trials are described in table 2 and 3, included in this summary4. Conclusion The document provides recommendations to improve the quality of evidence in wound management. This is achieved by formulating a set of statements within the following areas: n Different types of evidence required by different authorities n Evaluation of outcome n Outcome: endpoints in RCTs and comparative studies on non-healing wounds n Performance bias and interpretation of findings A full list of statements is found in the article published in Journal of Wound Care, Vol. 19, Iss. 6, 6 June 2010, pp 237-268). By formulating these recommendations (statements) we aim to provide guidance with regards to choosing and defining endpoints/ outcome measures (primary and secondary) when preparing an RCT or comparative study.

4 Table 15 and 16 in the full document.

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The key messages of the document can be summarized in the following messages: 1. A substantial number of publications exist – but we need to increase quality of evidence. 2. Consistency in measuring endpoints/outcomes improves quality. To reach consistency it is important to: – Use pre-defined and robust outcomes – Adapt outcomes to the intervention under investigation – Use the best evidence available 3. Using intact skin/healing as an outcome measure is not always possible/suitable – using the patient focus clarifies which other endpoints are relevant. 4. The term ‘chronic’ wound should be replaced with ‘non-healing’ wound. 5. “Basic care” must be standardised. 6. The Patient Outcome Group does not reject RCTs in wound management, but advocates that clinical trials using alternative endpoints to healing are evaluated as being equally suitable for the evaluation of various wound interventions. m

Useful documents giving guidance for evidence collection are listed in table 4. Key references n

Bell-Syer S, Brady M, Bruce J, Cullum N, Foxlee R, Jull A, Margolis D, Mclnnes L, Nelson A,O’Meara S, Ubbink D. Letter: Evidence-based wound care in the UK: A response to David Leapers Editorial in International Wound Journal April 2009 6 (2). 2009 Int Wound J; 6:306-9.

Biancari F, Salenius JP, Heikkinen M, Luther M, Ylönen K, Lepäntalo M. Risk-scoring method for prediction of 30-day ostoperative outcome after infrainguinal surgical revascularization for critical lower-limb ischemia: a Finnvasc registry study. World J Surg 2007;31:217-225.

Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacol Ther 2001; 69:89-95

Bouza C, Munoz A, Amata JM. Efficacy of modern dressings in the treatment of leg ulcers: a systematic review. Wound Rep Reg 2005; 13: 218-229.

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

Chaby G, Senet P, Veneau M et al. Dressings for acute and chronic wounds. A systematic review. Arch Dermatol 2007; 143: 1297-1304.

Carter MJ. Evidence-based medicine: An overview of key concepts. Ostomy Wound Manage 2010; 56: 68-85.

De Gruttola, et al Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials: Summary of a National Institutes of Health Workshop Control Clin Trials 2001; 22:485–502

Drummond MF, Schulpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes. Oxford University Press, Third Edition, 2005

Enoch S, Price PE. Cellular, molecular and biochemical differences in the pathophysiology of healing between acute wounds, chronic wounds, and wounds in the aged. World Wide Wounds August 2004; Available from www.worldwidewounds.com//2004/ august/Enoch/Pathophysiology-Of-Healing.html

Falanga V, Saap LJ, Ozonoff A. Wound bed score and its correlation with healing of chronic wounds. Dermatol Ther 2006;19:383-90

Gershatar M. Apelqvist J, Eneroth M, Larsson J, Nyberg P, Thörne J Complexity of factors related to outcome of neuropathic and neuroischemic/ischemic diabetic foot ulcers; a cohort study Diabetologia. 2009 Mar;52(3):398-407

Gottrup F: Evidence is a challenge in wound management. Editorial. Lower Extremity Wounds. 2006; 5: 74-65.

Gottrup, F. & Apelqvist, J.: The challenge of using randomized trials in wound healing, Br J Surg 2010; 97: 303–304

Gottup F, Appelqvist J, Price P: Outcomes in controlled and comparative studies on non-healing wounds: Recommendations to improve the quality of evidence in wound management, J Wound Care, 2010; 19: 237-268 

EWMA Table 4: Useful documents giving guidance for evidence collection

AQUA Institute, www.aqua-institut.de

DIN ISO EN 14155-1: ‘Clinical investigation of medical devices for human subjects – Part 1: General requirements’. Part 2: Clinical investigation plans’ (edited by Beuth Verlag, www.beuth.de)

FDA: Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds – Developing Products for Treatment Food and Drug Administration, June 2006 www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071324.pdf

FDA Wound Healing Clinical Focus Group. Guidance for industry: chronic cutaneous ulcer and burn wounds – developing products for treatment. Wound Rep Reg 2001; 9: 258-268ICH (International Conference of Harmonisation) e.g. Topic E 6: Guideline for Good Clinical Practice in the European Community, www.ich.org

MEDDEV 2.7.1. Dec 2009: Guideline on Medical Devices – Clinical evaluation: Guide for manufacturers and notified bodies, http://ec.europa.eu/enterprise/sectors/ medical-devices/files/meddev/2_7_1rev_3_en.pdf)

Nice/UK: Guideline manual 2009 www.nice.org.uk/ aboutnice/howwework/developingniceclinicalguidelines/ clinicalguidelinedevelopmentmethods/GuidelinesManual2009.jsp www.iqwig.de/cost-benefit-assessment.736. en.html

SIGN 50: A guideline developer’s handbook (SIGN: Scottish Intercollegiate Guidelines Network) January 2008, especially the Annex B ‘Key of evidence and grades of recommendations’ and Annex C ‘Methodology Checklist’ www.sign.ac.uk/guidelines/fulltext/50/index.html

IQWIG / D: General methods, www.iqwig.de/general- methods.428.en.html

IQWIG / D: Cost-benefit assessmentISPOR guidance www.ispor.org/PEguidelines/index.asp

MEDDEV 2, 12–2 May 2004: Medical Devices: Guidance Document – Guidelines on post market clinical follow-up, http://ec.europa.eu/enterprise/sectors/medicaldevices/files/meddev/2_12-2_05-2004_en.pdf

The Consort Statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials, www.consort-statement.org/ Mohr, D., Schultz, K.F., Altman, D.G. (for the Consort Group). Lancet 2001; 357: 1191-1194

• The Cochrane Collaboration, www.cochrane.org

Grey J E, Leaper D, Harding K: How to measure success in treating chronic leg ulcers (Editorial), BMJ 2009;338:b1434

Price P. The challenge of outcome measures in chronic wounds. J Wound Care. 1999;8:306-8

Hinchliffe RJ, Valk GD, Apelqvist J, Armstrong DG, Bakker K, Game FL et al. A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev 2008; 24(Suppl 1): S119–S144.

Prompers L, Huijbert M, Apelqvist J et al. Prediction of outcome in individuals with diabetes and foot ulcers: focus on the difference between individuals with and without peripheral artery disease. The EURODIALE-study. Diabetologia 2008 51 (5) 747-55

Horkan L, Stansfield G, Miller M: An analysis of systematic reviews undertaken on standard advanced wound dressings in the last 10 years, Journal of Wound Care, Vol 18 No 7, July 2009

Leaper D. Evidence based wound care in the UK (Editorial). Int Wound J 2009; 6: 89-91

Prompers L, Huijberts M, Schaper N, Apelqvist J, Bakker K, Edmonds M, Holstein P, Jude E, Jirkovska A, Mauricio D, Piaggesi A, Reike H, Spraul M, Van Acker K, Van Baal S, Van Merode F, Uccioli L, Urbancic V and G Ragnarson Tennvall. Resource utilisation and costs associated with the treatment of diabetic foot Diabetologia 2008; 51: 1826-1834

Levine, Susan; Petra Nass & Theresa Rogstad; Effectiveness Guidance Document: Methodological Guidance for the Design of Comparative Effectiveness Studies, Devices for Local Treatment of Chronic Wounds , CMTP Center for Medical Technology Policy, Version 1.0 Published August 2009

Ragnarsson-Tennvall G, Apelqvist J, Cost-effective management of diabetic foot ulcers. PharmacoEconomics. 1997;12:42-53 .

Ryan S, Eager C, Sibbald RG. Venous leg ulcer pain. Ostomy Wound Manage 2003; 49(4 Suppl): 16-23

Lipsky B A, Polis A B, Lantz K C, Norquist J M, Abramson M A: The value of a wound score for diabetic foot infections in predicting treatment outcome: A prospective analysis from the SIDESTEP trial, Wound Rep Reg, Volume 17, Issue 5, 2009, 671-677

Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: what is and what isn´t. BMJ 1996: 312: 71-72.

Vaneau M, Chaby G, Guillot B, Martel P, Senet P, Teot L, Chosidow O. Consensus panel recommendations for chronic and acute wound dressing. Arch Dermatol 2007; 143: 1291-1294.

Wolcott RD,Rhoads DD,Bennett ME, Wolcott BM, Gogokhia L,Costerton JW,Dowd SE.Chronic wounds and the medical biofilm paradigm. JWC 2010 19 45-53

Little C, McDonald J, Jenkins M G, McCarron P: An overview of techniques used to measure wound area and volume, J Wound Care 2009; 18: 250-253

Matousek S., A.K. Deva, Mani R: Outcome Measurements in Wound Healing Are Not Inclusive: A Way Forward Lower Extremity Wounds 2007; 6: 284-290

Moore K, McCallion R, Searle RJ, Stacey MC, Harding KG. Prediction and monitoring the therapeutic response of chronic dermal wounds. Int Wound J 2006; 3:89-96.

Neumann PJ,Tunis SR. Medicareand medical technology – The growing demand for relevant outcomes. N Engl J med 2010; 362: 377-379.

Palfreyman S, Nelson EA, Michaels JA. Dressings for venous leg ulcers: systematic review and meta-analysis. BMJ 2007; 335: 244.

Peinemann F, McGauran N, Sauerland S, Lange S. Negative pressure wound therapy: potential publication bias caused by lack of access to unpublished study results data. BMC Med Res Methodol 2008;8:4

Penhallow K. A review of studies that examine the impact of infection on the normal wound-healing process. J Wound Care 2005;14:123-6

Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs 2004; 13(3): 341-54.

Posnett J, Gottrup F, Lundgren H, Saal G, , The resource impact of wounds on health-care providers in Europe, J of Wound Care 2009; 18: 154-161

Price P E, Fagervik-Morton, H, Mudge, EJ, Hilde Beele, Jose Contreras Ruiz, Theis Huldt Nystrøm, Christina Lindholm, Sylvie Maume, Britta Melby-Østergaard, Yolanda Peter, Marco Romanelli, Salla Seppänen, Thomas E Serena, Gary Sibbald, Jose Verdú Soriano, Wendy White, Uwe Wollina, Kevin Y Woo, Carolyn Wyndham-White, K G Harding. Dressing related pain in patients with chronic wounds: an international perspective. Int Wound Journal 2008; 5: 159-171

The EWMA Patient Outcome Group was established as a EWMA Group in October 2008. Clinical / individual members: Finn Gottrup (Chair), Jan Apelqvist, Luc Gryson, Zena Moore, Patricia Price, Hugo Partsch, John Posnett Industry members 2010 (representatives from): Abbott Nutrition, Bbraun, Convatec, Covidien, KCI, Lohmann&Rauscher, Mölnlycke Healthcare, Paul Hartmann AG

Acknowledgements: The authors thank the following for their invaluable contribution to finalizing this document: • Martin Abel, Dr rer nat, Head of Medical & Regulatory Affairs, Lohmann & Rauscher GmbH & Co KG; Germany • John Posnett, BA, DPhil, Vice President of Health Economics, Smith & Nephew, UK Coordination: Julie Bjerregaard, EWMA Secretariat EWMA Journal

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Balanced surface capacity ratio More e. anc m r o f r pe ice. r p e Sam

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Increased conformability

AG-BS-1211-09/10

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www.sorbion.com

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Zena Moore EWMA President, chair of the EWMA Education Committee ewma@ewma.org

Introducing the EWMA Master Course Requests for more EWMA activities on education have, on different occasions, been made by EWMA members as well as the EWMA Cooperating Organisations. On a similar note, our industry partners have expressed interest in training courses focused on the needs of industry. It is with this background that the EWMA Council and EWMA Education Committee are proud to introduce the EWMA Master Course as a new educational activity. The 1st EWMA Master Course including a parallel course aimed specifically at the needs of industry will take place in Budapest, Hungary on the 13-14 October 2011. The EWMA Master Course is expected to take place annually in the autumn, offering a mixture of theoretical and practical sessions at an advanced level. It is targeted at a mixed group of international clinicians (physicians and nurses), industry representatives and students. The Master Course differs from the EWMA Conference on most parameters including concept, structure and objectives. However, being a EWMA activity it will help EWMA fulfil its objective of playing an active role in changing the day-to-day practice of wound care at all levels. The EWMA Master Course will be arranged in cooperation with the national society (-ies) of the country in which the course takes place.

The 1st EWMA Master Course: Objective, theme and content The EWMA Master Course will address the educational needs of clinicians, and emphasises the importance of addressing the issues of health economy, outcome, evidence-based research and practice within wound care. For the 1st EWMA Master Course in 2011 the overall theme will be: Is Oedema a Challenge in Wound Healing?

Through a mixture of lectures, workshops and interactive sessions the course will bridge theory and practice, addressing a broad range of topics including: n Oedema as a problem in different types of wounds and what impact it has; n The pathophysiology of oedema; n Psycho-social impact of oedema; n Methods for diagnosing different types of oedema; n Prevention and management of oedema; n Associated skin complications of oedema; n Development of evidence-based outcome measurement of oedema in wound healing. A full draft programme of the EWMA Master Course including the Industry Course will be available on the www.ewma.org website during October and this will be updated regularly. Participants at the EWMA Master Course will be entitled to Continued Medical Education Credits. The exact number of credits to be granted for Master Course participants will be announced on the EWMA website.

Industry Course In parallel with the EWMA Master Course, a special Industry Course aimed at the continuous education of wound care industry representatives will be offered. By participating in the industry course, industry staff is given access to lectures and workshop training offered by highly skilled professional educators and instructors with expert knowledge on a broad range of specific subjects related to wound care. The overall theme of the Industry Course will be: Challenges of providing wound care in Europe: Reimbursement, health technology assessments and generating evidence.

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Is Oedema a Challenge in Wound Healing? Background The challenges faced by European clinicians in providing safe, effective and efficient wound-care services are numerous and increasingly influenced by the changing demographics and the continuing rise in wound prevalence and incidence. In addition, considerations regarding health economics play an ever increasing role in the decision-making process in the health care sector. Health economy is based on the concept of scarcity, which suggests that there will never be sufficient resources to meet the ever changing health needs of society (Phillips 2005). Thus, the underlying premise is that the delivery of health care should be founded on equity and efficiency, in other words, making the best use of the resources that are available (Phillips 2005).

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Education and training in wound management alters the individual’s characteristics, such that those with specific training are in a greater position to affect positive change within the clinical setting. Thus, focusing on training in wound management is particularly important to EWMA in ensuring that there is a greater knowledge pool within the clinical arena, ultimately leading to more cost effective, efficient provision of wound care services. I trust that the EWMA Master Course will be a successful development in the area of education and look forward to meeting EWMA members, nurses and physicians, industry employees and wound-care students in Budapest on the 13-14 October 2011. m

The EWMA UCM:

A financing model and feedback from Geneva Luc Gryson Member of the EWMA Council, Education Committee

Zena Moore EWMA President, chair of the EWMA Education Committee ewma@ewma.org

Since piloting the EWMA University Conference Model (UCM) in Glasgow in 2007, this education activity has consistently been evaluated as very successful by the participating students and their coordinators. Some opinions by this year’s 65 students are presented in the text Evaluation of the EWMA UCM in Geneva below. While satisfaction with the EWMA UCM programme remains solid, the main challenge for most institutions and students participating continues to be the financing of the conference participation. The Belgian institutions together with the Flemish wound management association seem to have found a viable model which is presented below.

The financing model used in Belgium Since the early beginning of the postgraduate education in “Wound Management, Ostomy Care and Tissue Repair”, participation in the EWMA conference has been an essential part of the course. Participation in the EWMA UCM is awarded 4 ECTS points and integrated in the “capita selecta” part of the curriculum, which may be designed according to the individual interest of each student. Maintaining the annual presence of Belgian students in the EWMA UCM is not an easy task as post-graduate courses are not subsidised in Flanders; thus everything must be paid for by the student or his/her employer. The full post-graduate course (60 ECTS points, 2 years part time study) costs EUR 2,200 + travel and hotel expenses for participation in EWMA and other conferences.

The Flemish Wound Management Association “CNC” is convinced of the importance of having wound management education for doctors and nurses all over Flanders. For that reason it has made an agreement with an association of universities and university colleges to support the wound management program. The association has an industry committee, at this moment consisting of 21 local companies, which pay an annual membership fee. Part of the proceedings of this fee is used to cover the student fees for participation in the EWMA UCM, currently set at EUR 225. The students themselves pay for transport and accommodation during the conference. This way the university succeeds in offering the full postgraduate programme for less than EUR 3,000 everything included.

Evaluation of the EWMA UCM in Geneva The following observations are extracts of the full list of comments at the feedback session on Friday 28 May 2010, attended by approximately 55 students and coordinators. • In general students as well as coordinators expressed great satisfaction with the EWMA UCM programme in Geneva; • Larger meetings rooms and repetition of the most popular workshops prevented problems in getting access, which had been experienced in earlier years; EWMA Journal

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• The UCM gives access to a wealth of knowledge, which is not available in classroom, and it allows time for studying which ordinarily would be difficult for a nurse to find; • It was good to meet the people I usually reference a lot, good to be able to share with other clinicians and learn about different treatments in their countries. • As a podiatrist I’m used to a hierarchic structure, but here I have experienced a very open and relaxed ambience; • The highlight for me is the evidence focus. We always need to think of evidence in our daily practice. • Access to presentations, if possible from all sessions, but at least from the plenaries, after the conference would be highly relevant; • The exhibition should be open for more hours every day as it is sometimes difficult as a student to find the time to go there; • It is recommended to have a workshop on how to make a presentation, poster, case story etc. • EWMA is requested to help identify financial support as it represents a huge financial effort for many students to be present. (See “The financing model used in Belgium” above). The UCM pilot project in 2007 was made possible by an unrestricted educational grant by Coloplast. EWMA wishes to thank KCI for providing selected study materials to the UCM participants.

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The following teaching institutions participated in the 2010 Geneva conference: Haute École de Santé, Geneva, Switzerland HUB Brussels, Belgium KATHO University College, Roeselare, Belgium University of Hertfordshire, UK Universidade Católica Portuguesa, Portugal Escola Superior de Enfermagem de Lisboa, Portugal

Financing / Participating in the EWMA UCM: An example Participation in the EWMA UCM requires payment of accommodation, transport and the student conference fee. In total this may amount to approx EUR 600 if tickets and budget accommodation are booked well in advance of the EWMA conference. Paid by university and company committee: Conference fee: EUR 225. Paid by each student or his / her employer: Cost of accommodation and travel: EUR 375 or cheaper, depending on the standard preferred and the time of booking.

EWMA 2010 GENEVA

T Sue Bale EWMA Recorder ewma@ewma.org

All abstracts are published in the EWMA Journal Electronic Supplement May 2010. Download from www.ewma2010.org

he 20th EWMA conference was held this year on 26th-28th May at Palexpo in Geneva, Switzerland with the theme “Get the Timing Right”. The conference was organized in cooperation between EWMA and the Swiss Association for Wound Care (SAfW) as a trilingual conference with all plenary sessions simultaneously translated into English, French and German.

The conference was attended by more than 2500 participants from all over Europe, and also welcomed participants from other continents and countries including the USA, Brazil and Taiwan. In total, 70 countries were represented at the conference and this event proved to be as successful as previous EWMA conferences. The conference programme covered a wide variety of topics throughout key sessions and workshops. The nine key sessions addressed topical issues such as ‘Wound care concepts in countries with low resources’ and ‘The value of health economics in wound care’ among others. A further 12 workshops explored more practical approaches to specific wound management issues. For EWMA the Scientific Committee accepted 347 abstracts for poster presentation and 103 oral presentations in the free paper sessions. These can now be downloaded from the conference web site www.ewma2010.org. Over the duration of the event judges assessed first time presenters and decided that three oral presentations were of a high quality and were particularly outstanding. The first time presenter awards were given to: n Otilija Mertelj from Slovenia n Camilla Eskilsson from Sweden n Olga Labovitiadi from the United Kingdom In total more than 600 scientific presentations were given at the conference by international key speakers, free paper presenters, poster presenters, workshops and satellite symposia.

This year the poster award committee decided to award 4 posters: n Magdalena A. Gershater, Carin Alm-Roijer, Ewa Pilhammar Andersson, Jan Apelqvist from Sweden n Inger Futtrup, Anne Lee, Iben Fasterholdt, Kristian Kidholm, Jørgen Lauridsen, Jens Lykke Sørensen from Denmark n Janine Prytherch from the United Kingdom n Coralie Clerc, Aline Tereins, Cécile Michelle Mengue Zie from Switzerland

Perhaps one of the lasting effects of this year’s EWMA conference will be the step taken by EWMA to strengthen the scientific work carried out within wound management. At the conference, the first publication of the EWMA Patient Outcome Group was presented in the opening ceremony. Further debates about the document, ‘Outcomes in controlled and comparative studies on non-healing wounds: Recommendations to improve the quality of evidence in wound management’ continued during the conference. It is an aspiration of EWMA that the conference participants will continue these debates in their respective countries and thereby support the work to create awareness about the current challenges and suggested solutions for the achievement of high level evidence in wound management. Together with the broad range of themes in the plenary and key sessions as well as the practical workshops, we hope that a greater degree of theoretical and practical understanding of issues in wound care was achieved. EWMA Journal

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Zena Moore, Sue Bale, Jacques-André Romand, Severin Läuchli and Hubert Vuagnat at the opening session.

EWMA 2010 A major contributor to the success of the EWMA 2010 conference was the active involvement of several other wound organisations including The European Tissue Repair Society (ETRS) which arranged a session dealing with updates in infection and biofilm and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) which had a guest session on the subject of ‘The complicated wound after orthopaedic surgery’. Other sessions were organized by Dystrophic Epidermolysis Bullosa Research Association (DEBRA), underlining the fact that these collaborations are an important aspect of the creation of networks between associations working within wound care and related issues. As always the EWMA conference included a comprehensive exhibition of the industry products available within wound care. In total 79 companies had chosen to present their products for the conference participants in Geneva and, of these, 19 companies were exhibiting for the first EWMA Journal

2010 vol 10 no 3

time at a EWMA conference. EWMA is very grateful for this close collaboration with the wound care industry and considers the industry participation as an essential element of the EWMA conference. Geneva 2010 was undoubtedly an enjoyable and informative experience for delegates marking yet another EWMA event that brings together the European wound healing community and, perhaps most importantly, creates and strengthens links between national associations striving to increase the profile of wound management within their respective countries. The conference is more than scientific presentations and educational courses, because, at the same time, it is an important forum to network, let research topics grow and give projects operating in one country a new life in another. The Geneva conference closed with a display of the venue for the 21th EWMA conference to be held in Brussels, Belgium May 25-27, 2011. Please visit the conference web site www.ewma2011.org for further information. We look forward to seeing you all at the next EWMA  conference in Brussels. 61

EWMA 2010 FIRST TIME PRESENTER AWARDS: The EWMA First Time Presenter Award was given to the following presenters: Presented at the 19th Conference of the European Wound management Association 20-22 May 2009 Helsinki, Finland

Camilla Eskilsson University of Borås. School of Health Sciences (Borås, Sweden)

TO CARE FOR PATIENTS WITH HARD-TO-HEAL WOUNDS HOMECARE NURSES’ NARRATIVES Aim: To describe how nurses in homecare experience the care of patients with hard-to-heal wounds. Method: This study has a lifeworld phenomenological approach. Seven nurses in homecare were interviewed. The data was analyzed in terms of meaning. Results: Four themes emerged. To be responsible means both to heal the wound and relieve the patient’s suffering. In this respect, good care depends on inter-professional collaboration, but the nurses ascribe the physicians a lack of interest. To be respectful means a shift in focus from wound to person to holistically confirm the patients. To feel secure in order to provide security means that the nurses want patients to experience confidence in their care, so they must experience professional confidence themselves. There are also temporal and spatial meanings in this: the caring relationship is more likely to be personal if frequent caring events take place in their home contexts. However, the caring relationship should be professional and personal but not private. This invisible border must be emphasized. Conclusions: Nurses need wound treating competence from education as well as clinical support in their daily care. Preferably, there should be some sort of mentoring that offers opportunities to professional reflections on care. Finally, the shared responsibility between nurses and physicians needs improvement.

Olga Labovitiadi Kerr Matthews, Andrew Lamb. The Robert Gordon University (Aberdeen, United Kingdom)

FORMULATION AND EVALUATION OF NOVEL ANTIMICROBIAL WAFERS FOR THE TOPICAL TREATMENT OF CHRONIC WOUNDS Aim: To formulate lyophilised wafers containing a selection of broad spectrum antimicrobial compounds and test their efficacy against common wounds pathogens using an in vitro wound model based on a modified disc diffusion method. Methods: Lyophilised wafers were produced by casting karaya gels (1.5 ± 0.02 g) containing clinical concentrations of either neomycin sulphate (NS), povidone iodine (PVPI), chlorhexidine digluconate (ChD) or silver sulfadiazine (SS) into disc moulds and freeze-drying. The antimicrobial properties of the wafers produced were tested in vitro using nutrient agar plates inoculated with 5 x 105 cfu/ml methicillin resistant S. aureus, E. coli and P. aeruginosa. Microbial inhibition and wafer expansion were measured at 37°C for 24 hours and calculated as ratios of the initial wafer diameter. The relative adhesion of wafers to a 0.8% w/v agar surface, containing quantities of sodium and calcium ions typical of wound fluid, was also measured (N.cm-2). Results: Inhibition ratios ranged from 0 to 2.3, and NS, ChD and SS were effective against all bacterial strains although PVP-I did not produce an inhibition zone against P. aeruginosa. All wafers formed weak gel networks, swelling with expansion ratios ranging from 1.05 to 1.20. Adhesive forces varied from 0.10 to 0.25 N.cm-2, the control wafer displaying the highest value and PVP-I the lowest. Conclusions: The efficacy of antimicrobial wafers against common wound pathogens was apparent although adhesion decreased with the inclusion of antimicrobial compounds.

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EWMA

EWMA 2010 POSTER AWARDS: How to design a RCT for evidence based intervention to prevent diabetes foot ulcers Magdalena A. Gershater, Carin Alm-Roijer, Ewa Pilhammar Andersson, Jan Apelqvist (Sweden)

Otilija Mertelj Mateja Lopuh, Zdenka Kramar. General hospital Jesenice (Jesenice, Slovenia)

Health Technology Assessment of Problem Wounds treated in Patient’s Homes by Specialized Wound Nurses from University Center of Wound Healing, Odense, Denmark Inger Futtrup, Anne Lee, Iben Fasterholdt, Kristian Kidholm, Jørgen Lauridsen, Jens Lykke Sørensen (Denmark)

ETHICAL DECISION MAKING DILLEMAS IN PREVENTION OF PRESSURE ULCERS IN TERMINALLY ILL PATIENTS Introduction: It is widely accepted that prevention of pressure ulcers (PU) is one of main goals in health care. Incidence of PU has been controlled. The rationale behind is well understood as healing of PU is time consuming, costly and a burden for patients. Terminally ill patients may have pains that worsen with repositioning. Strictly following the treatment protocol doesn’t allow them to rest although this may be wished. Our medical nurses (MN) have been faced with the dillema how to treat such patients. Methods: A questionnaire (6 questions) has been developed to find out what is best policy for prevention of PU in the eyes of MN. 36 MN participated in the survey. The questionnaires were collected. Descriptive statistics has been used for analysis. Results: In 36 correctly filled questionnaires 94.4% MN have met the dillema in implementing the protocol for PU prevention. Still 75% believe that patients should be repositioned every two hours. An active support surface would be used by 83.3%. 91% of MN think that skin should be assessed regularly and 50% would use modern bandages. Non painful treatment of PU is a priority for 72.2% of MN. Conclusions: MN have faced the dillema how to treat PU in terminally ill patients. Palliative care aims to provide patients as much comfort as possible. So protocols for PU prevention should be adjusted. MN will be helped to better understand this philosophy and care for these patients without feelings of guilt and negligence. EWMA Journal

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Compression therapy for mixed venous arterial disease Janine Prytherch (United Kingdom)

Wound care: Swiss training and Cameroonian reality Coralie Clerc, Aline Tereins, Cécile Michelle Mengue Zie (Switzerland):

Appreciations Council Members Leaving, May 2010 By Zena Moore, EWMA President

Marcus Gürgen

joined EWMA Council in 2007 as a representative e lected by the Cooperating Organisations of EWMA. Marcus is also a member of the Cooperating Organisation’s Board, representing the Norwegian wound care association, NIFS. Through this, he has strengthened the link between EWMA and the Norwegian clinicians involved in wound management. With his pleasant nature and valuable contribution to the discussions in Council, we will miss Marcus’ presence at the meetings. We are sure that you will maintain the link to EWMA through your engagement in the Cooperating Organisation’s Board and your involvement in other EWMA activities. On behalf of all the EWMA Council members, I would like thank you for your contribution.

José Verdu Soriano joined EWMA Council in 2007. Besides represent-

ing the Spanish association GNEAUPP (National Advisory Group for the Study of Pressure Ulcers and Chronic Wounds) in the Cooperating Organisations Board, he has also been a member of the EWMA Scientific Committee and the Editorial Board. Through his involvement in the Scientific Committee and the Editorial Board, José has contributed to the continued development of the scientific profile of EWMA; with regard to the conference programme as well as the EWMA Journal. Through his strong engagement in the Spanish association, José Verdu Soriano is a driving force in bringing attention to the problems related to wounds in Spain. This work is highly appreciated by EWMA and on behalf of the EWMA Council I would like to express a wish for the continuation of a strong collaboration. I therefore hope that this is not a ‘goodbye’, but that you will maintain your active engagement in the EWMA as member of a committee or return to Council one day.

Rita Gaspar Videira

joined EWMA Council in 2007 as a representative elected by the Cooperating Organisations of EWMA. During her years in Council, Rita also joined the Editorial Board. We first got to know Rita when she was a member of the Local Organising Committee for the EWMA 2008 Conference, which was held in Lisbon, Portugal. Since the first meeting, the EWMA Council has benefitted from Rita’s strong engagement in wound management as well as her kind and cheerful spirit. As a member of the Editorial Board, Rita Videira has contributed with ideas as well as paper reviews for the EWMA Journal, thereby contributing to maintaining the quality of the journal. Even though Rita has now started to invest her energy and engagement in a PhD, I hope that she will remain engaged in EWMA in the years to come. On behalf of the EWMA Council members, I would like to wish you good luck with your continued studies. We look forward to further collaboration with you in the future. 64

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EWMA Activities Update EWMA is pleased to welcome the following new members of Council Elected in May 2010:

Barbara den Boogert-Ruimschotel Reinier de Graaf Hospital The Netherlands

Dubravko Huljev GH “Sveti Duh” Croatia

Robert Strohal Federal University Teaching Hospital Feldkirch, Austria

Update from the EWMA Patient Outcome Group

EWMA Guest sessions at the EFORT 2010 Conference

After the publication of the first document by the EWMA Patient Outcome Group, “Outcomes in controlled and comparative studies on non-healing wounds – Recommendations to improve quality of evidence in wound management” (Published in Journal of Wound Care, June 2010), many activities have been initiated to secure implementation of the key messages in the document.

On the 3rd of June 2010, an international group of EWMA representatives held two guest sessions at the 11th conference of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), held in Madrid, Spain. The guest sessions were arranged as part of a collaboration agreement between EFORT and EWMA, aiming at an increased understanding of the management of problem wounds within of the field of orthopaedic surgery. As part of this agreement, EFORT arranged a reciprocal guest session during the EWMA 2010 Conference held in May 2010 in Geneva.

To secure dissemination, the Co-operating Organisations of EWMA have been offered the opportunity to translate and publish the full document or a document summary in their national journals. Several associations have already accepted this offer. The document has also been presented to various groups working within the field of wound management, and will be presented and discussed at relevant national, European and international meetings in the years to come. With this procedure, the Patient Outcome Group aims to enter a constructive discussion with various relevant stakeholders. Based on this discussion, further activities will be initiated by the group in the near future, with the aim of attaining a general improvement of the quality of evidence in wound management and overcoming the barriers to reaching high standards of patient care in Europe. Any questions concerning the Patient Outcome Group or the document can be sent to the EWMA Secretariat: ewma@ewma.org The document can be downloaded free of charge from www.ewma.org

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The first EWMA session included presentations on the multidisciplinary challenge of wound management, underlining the role of the orthopaedic surgeons. The second session focused on pressure ulcer management, with a focus on risk assessment, structure of treatment and new technologies, again underlining the orthopaedic viewpoint. The group included a number of highly qualified speakers with great knowledge of the various areas of wound management, including Finn Gottrup (Denmark), Jan Apelqvist (Sweden), Sue Bale (UK), Marco Romanelli (Italy), José Verdu Soriano (Spain), Rytis Rimdeika (Lithuania), Agneta Folestad (Sweden) and Giuseppe Calvosa (Italy). Both sessions were well received by the participants who left the conference with a broader awareness and understanding of problem wounds related orthopaedic surgery. It is the hope of EWMA that they will spread this knowledge in their respective countries and thereby support the multidisciplinary approach to wound management, which is so crucial for improved levels of treatment offered to the patients.

EWMA

The Cooperating Organisations Board Meeting 2010

A Marco Romanelli EWMA Immediate Past President Chair of the Cooperating Organisations Board ewma@ewma.org

s usual the annual meeting of the EWMA Cooperating Organisations Board took place during the EWMA Conference. The Board meeting was attended by 59 participants, including 33 board members or their representatives.

out that the meeting is an opportunity to express opinions on subjects related to the cooperation. Further, more activities at EWMA Conference aimed specifically at bringing the Cooperating Organisations together and strengthening their collaboration are suggested.

Election of new members for the EWMA Council The Board members elected two new members to serve on the EWMA Council for the next three years. In addition to contributing to the work of the Council, they will represent the Cooperating Organisations in Council. The elected candidates are: n Barbara den Boogert-Ruimschotel, V & VN Decubitus and Wound Consultants, Netherlands n Dubravko Huljev, Croatian Wound Association, Croatia They replace Rita Videira and Marcus Gürgen whose work for the EWMA Council during the last three years is acknowledged and applauded in a separate entry in this issue of the EWMA Journal.

Patient Outcome Group (POG) and Teach the Teacher In general the participants were satisfied with the group work & discussions about the implementation of the results of the work of the POG and the Teach the Teacher project. Much interest was expressed in the work of the POG and many participants would like to be involved in disseminating the POG Outcome document in their countries. Specifically, a followup session regarding the POG at next year’s conference was requested. For future improvement, it is suggested that the group work material is handed-out before the start of the meeting.

Evaluation of the Board meeting The meeting was evaluated by means of a questionnaire-based survey sent out to the Board members participating in the meeting; responses were received from 18 board members. The responses indicate great satisfaction on the meeting in general (76% answering good/very good) as well as themes, duration (86% appropriate) and information given prior to the meeting (100% good/very good). A large majority of the respondents highlighted networking as a main objective for participating in the Board meeting; about 2/3 of the respondents attended the meeting to be informed about wound care activities across Europe. To enhance networking it is suggested to circulate an e-mail list of meeting participants. It was suggested that the meeting could be improved by providing more guidance on what is expected from the representatives before the meeting. For instance, it could be more clearly pointed 66

Proposals on topics for debate Many suggestions on themes and debate topics for next year’s meeting were made, including: n Encourage collaboration and improved sharing of knowledge about the Cooperating Organisations by means of more society presentations; n Share the results of EWMA working group activities and information about how to participate in working groups more frequently and across a wider audience; n Exchange ideas about educational models and development of education programs for physicians and nurses together; n Discuss and compare the status of wound healing in the different countries and the creation of a European chronic wound register through member participation. As chair of the Board meeting I would like to thank the participants for their constructive and forward-looking inputs and for contributing to developing the Board meeting by adding their experience and opinion to the evaluation. m EWMA Journal

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21st Conference of the European Wound Management Association 21 Congrès de l’Association Européenne de Soins de Plaies

EWMA 2011 25 -27 May

25 -27 mai

Brussels · Belgium

Bruxelles · Belgique

gual: Bilin French sh & ée Engli ultan m i s n s i ctio nça Tradu lais et Fra Ang

Organised by the European Wound Management Association in cooperation with:

Organisé par: L’Association Européenne de Soins de Plaies (EWMA) qui sera organisée en coopération avec:

Francophone Nurses’ Association in Stoma Therapy, Wound Healing and Wound Belgian Federation of Woundcare CNC Wound Management Association

WWW.EWMA.ORG/EWMA2011

Corporate Sponsor Contact Data Corporate A

Abbott Nutrition 200 Abbott Park Road Abbott Park Illinois 60064 USA Tel: +1 (614) 624-7485 Fax: +1 (614) 624-7899 www.abbottnutrition.com

Paul Hartmann AG Paul-Hartmann-Strasse D-89522 Heidenheim Germany Tel: +49 0 7321 / 36-0 Fax: +49 0 7321 / 36-3636 www.hartmann.info

ConvaTec Europe Harrington House Milton Road, Ickenham, Uxbridge UB10 8PU United Kingdom Tel: +44 0 1895 62 8300 Fax: +44 0 1895 62 8362 www.convatec.com

Covidien 154, Fareham Road PO13 0AS Gosport United Kingdom Tel: +44 1329 224479 Fax: +44 1329 224107 www.covidien.com

KCI Europe Holding B.V. Parktoren, 6th floor van Heuven Goedhartlaan 11 1181 LE Amstelveen The Netherlands. Tel: +31 0 20 426 0000 Fax: +31 0 20 426 0097 www.kci-medical.com

Lohmann & Rauscher P.O. BOX 23 43 Neuwied D-56513 Germany Tel: +49 0 2634 99-6205 Fax: +49 0 2634 99-1205 www.lohmann-rauscher.com

Use the EWMA Journal to profile your company Deadline for advertising in the January 2011 issue is 15 November 2010

Mรถlnlycke Health Care Ab Box 13080 402 52 Gรถteborg, Sweden Tel: +46 31 722 30 00 Fax: +46 31 722 34 01 www.molnlycke.com

Ferris Mfg. Corp. 16W300 83rd Street Burr Ridge, Illinois 60527-5848 U.S.A. Tel: +1 (630) 887-9797 Toll-Free: +1 (630) 800 765-9636 Fax: +1 (630) 887-1008 www.PolyMem.eu

Sorbion AG Im Suedfeld 11 48308 Senden Germany Tel.: +49 (0) 2536 34 400 400 Fax: +49 (0) 2536 34 400 410 www.sorbion.com

Systagenix Wound Management Gargrave North Yorkshire BD23 3RX United Kingdom Tel: +44 1756 747200 Fax: +44 1756 747590 www.systagenix.com

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EWMA

Corporate B 3M Health Care Morley Street, Loughborough LE11 1EP Leicestershire United Kingdom Tel: +44 1509 260 869 Fax: +44 1 509 613326 www.mmm.com

Advanced BioHealing, Inc. 10933 N. Torrey Pines Road, Suite 200 La Jolla, CA 92037 Tel: 858.754.3705 Fax: 858.754.3710 www.AdvancedBioHealing.com

AOTI Ltd. Qualtech House Parkmore Business Park West Galway, Ireland Tel: +353 91 660 310 Fax: +353 1 684 9936 www.aotinc.net

ArjoHuntleigh 310-312 Dallow Road Luton LU1 1TD United Kingdom Tel: +44 1582 413104 Fax: +44 1582 745778 www.ArjoHuntleigh.com

B. Braun Medical 204 avenue du Maréchal Juin 92107 Boulogne Billancourt France Tel: +33 1 41 10 75 66 Fax: +33 1 41 10 75 69 www.bbraun.com

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Curea Medical GmbH Münsterstraße 61-65 48565 Steinfurt Germany Tel: +49 36071 9009500 Fax: +49 36071 9009599 www.curea-medical.de

Flen pharma NV Blauwesteenstraat 87 2550 Kontich Belgium Tel.: +32 3 825 70 63 Fax: +32 3 226 46 58 www.flenpharma.com

HILL-ROM 83, Boulevard du Montparnasse 75006 Paris France Tel: +33 (0) 1 53 63 53 73 Fax: +33 (0) 1 53 63 53 70 www.hill-rom.com

Life Wave 1 Azrieli Center, Round Tower 41st floor Tel Aviv 67021 Israel Tel: +972-3-6095630 Fax: +972-3-6095640 www.life-wave.com

Nutricia Advanced Medical Nutrition Schiphol Boulevard 105 1118 BG Schiphol Airport The Netherlands www.nutricia.com

Organogenesis Switzerland GmbH Baarerstrasse 2 CH-6304 Zug Switzerland Tel: +41 41 727 67 89 www.organogenesis.com

Polyheal Ltd. 42 Hayarkon St. 81227 Yavne Israel Tel: +972 8 932 4000 Fax: +972 8 932 4001 www.polyheal.co.il

Argentum Medical LLC Silver Antimicrobial Dressings 2571 Kaneville Court Geneva, Illinois 60134 U.S.A. Tel: +1 630-232-2507 Fax: +1 630-232-8005 www.silverlon.com

Laboratoires Urgo 42 rue de Longvic B.P. 157 21304 Chenôve France Tel: +33 3 80 54 50 00 Fax: +33 3 80 44 74 52 www.urgo.com

Welcare Industries SPA Via dei Falegnami, 7 05010 Orvieto ( TR ) Italia Tel: +39 0763-316353 Fax +39 0763-315210 www.welcaremedical.com

Conference Calendar Conferences

Theme

NOVW Practicum 2010

The multidisciplinary structure of woundcare

2010

Days

City

Country

Oct

Ede

The Netherlands

Quatrième congrès national de la Belgian Federation of Wound Care associations

Oct

Brussels

Belgium

Simpozij Dijabeticko Stopalo

Oct

19-22

Zagreb

Croatia

Yara Bakım ve Doku Onarımı Derne ǧinin düzenlediǧi Ulusal Yara Bakımı

Oct

25-28

Gaziantep

Turkey

A Magyar Sebkezel” o Társaság

Oct

28-29

Budapest

Hungary Spain

VIII Simposio Nacional sobre Ulceras por Presión y Heridas Crónicas

Nov

10-12

Santiago de Compostela

Congresso APTFeridas

Nov

17-19

Porto

Portugal

Nov

25-26

Kolding

Denmark

Paris

France

Dansk Selskab for Sårheling Årsmøde

Venøse bensår – ætiologi, diagnostik og behandling

2011 Conference Nationale Des Plaies et Cicatrisations 2011

Jan

16-18

Wounds International

Feb

1-3

Cape Town

South Africa

Feb

3-4

Værnes

Norway

Tissue Viability Society Conference 2011

April

Telford

United Kingdom

6th International Symposium on the Diabetic Foot

May

11-14

Noordwijkerhout The Netherlands

AISLeC

May

12-14

Bologna

Italy

May

25-27

Brussels

Belgium

NIFS-seminar

Det kompresjonstrengende sår

EWMA. 21st Conference of the European Wound Management Association

Common Voice – Common Rights

12th EFORT Congress

Jun

1-4

Copenhagen

Denmark

DGfW

Jun

23-25

Hannover

Germany

EPUAP. 14 th Annual European Pressure Ulcer Meeting

Pressure Ulcer Research Achievements Translated to Clinial Guidelines

Aug Sep

31-2

Oporto

Portugal

EBJIS2011. 30th Annual meeting of the European Bone and Joint Infection Society

Biofilm and Health Economics in Bone and Joint Infections

Sep

15-17

Copenhagen

Denmark

Pisa International Diabetic Foot Courses

Oct

3-6

Pisa

Italy

EWMA Lec Ulcer and Compression Seminars

Oct

10 11 13

Bratislava Vienna Budapest

Slovakia Austria Hungary

Oct

13-14

Budapest

Hungary

23-25

Vienna

Austria

EWMA Master Course 2011

Is Oedema a Challenge in Wound Healing?

2012 22nd Conference of the European Wound Management Association

May

For web addresses please visit www.ewma.org

· EW

IA T I O N

E U R OP EA

E· RS

EWMA Master Course

MASTER COU MA

· M A NA GE M E

·A

13-14 October 2011 · Budapest, Hungary

Is Oedema a Challenge in Wound Healing? 70

www.ewma.org

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Organisations

13th European Pressure Ulcer Advisory Panel Meeting An important part of the conference was the integration of four new initiatives n The 2010 EPUAP Novice Investigator Award: Awarded to Ms. Claudia Gorecki (University of Leeds, UK); n The 2010 EPUAP Experienced Investigator Award: Awarded to Prof. Tom Defloor (Ghent University, Belgium). n Student free paper competition n Oral poster presentations

Trudie Young Co-Chair of the Scientific Committee of EPUAP

As always inter-professional networking was a key part of the conference and the informal networking surrounding the event was evident throughout the conference and at the enjoyable gala dinner. Dr. Carol Dealey, past president of the EPUAP was presented with a plaque for her contribution to EPUAP and specifically her work on leading the European contribution to the development of the International Pressure Ulcer Prevention and Treatment Guidelines (www.epuap.org/guidelines.html).

www.epuap.org

University of Birmingham – the exhibition

The 13th EPUAP conference took place in early September at the University of Birmingham, UK, with the theme of the conference being ‘The Flourishing of Science to support Prevention and Healing’. The conference was a great success with over 400 delegates supported by a comprehensive exhibition that included 25 companies. The exhibition and adjacent poster display were held in the impressive surroundings of the Great Hall of the University. The high standard of the lecturers was set with the opening presentation from the President of the EPUAP, Dr Cees Oomens. The scientific program, featuring a good representation of presenters from Europe along with speakers from Australia, Canada, Japan and USA, was well received and was both interesting and informative. In addition to the plenary sessions there were four free paper sessions, three symposia by Danone, Gaymar and KCI, an ArjoHuntleigh workshop, the EHOB breakfast session and an update from the ISO work programme.

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Amit Gefen, Prof Co-Chair of the Scientific Committee of EPUAP

The European Pressure Ulcer Advisory Panel is proud to present Dr. Carol Dealey, University of Birmingham, an achievement award for her significant contribution to the succes of the E PUAP and the development of guidelines for the prevention and treatment of pressure ulcers.

The Annual General meeting of the EPUAP took place during the meeting in which a new president elect was chosen, Dr Michael Clark. EPUAP is now busy planning the 14th conference which will take place in Porto, Portugal, 31st August - 2nd September, 2011. The conference theme is ‘Pressure Ulcer Research Achievements Translated to Clinical Guidelines’ further information is available at www.epuap.org/flyer/Oporto2011.pdf. EPUAP looks forward to seeing many EWMA colleagues at the meeting. m

DGfW

German Wound Healing Society

Report from the 13th annual meeting of the German Society for Wound Healing and Wound Management (DGfW), Freiburg, Germany The 13th annual meeting of the German Society for Wound Healing and Wound Management (DGfW) took place in Freiburg, Germany from June 17-19. With more than 2,500 participants, and over 40% of those physicians, the conference was exceptionally well attended.

PD Dr Karsten Knobloch, MD, PhD Plastic, Hand and Reconstructive Surgery, Hannover Medical School, Germany, knobloch.karsten@ mh-hannover.de

Martin Koschnick, MD Department of Plastic Surgery, National Cancer Hospital of Portugal, Lisbon, Portugal EWMA Council member

The theme of the conference was “Guidelines and quality standards in wound surgery” which was promoted by conference president Dr Stephan Eder (Konstanz, Germany). Given the history of surgeons, wound care has been one of their foremost duties. Therefore various aspects of the role of surgery in wound care were included in the fully-packed three day conference schedule. German minister of health, Dr Philipp Rösler stated that chronic wounds are a great challenge for modern medicine. Beyond the limitations for the patient suffering wound problems, the enormous costs in healthcare are alarming. This is why it is important that organizations promoting wound care and wound management, such as the DGfW, are widely supported. Prof. Dr Peter M. Vogt, current president of the DGfW as well as current president of the German Society of Plastic, Reconstructive and Aesthetic Surgeons (DGPRÄC), underlined the interdisciplinary and multi-professional approach of the society. The conference brought together experts from various disciplines, such as physicians, nurses, wound experts, lymphologists, podiatrists and physiotherapists; together they seek to improve wound care and wound management.

DGfW –EWMA co-organised session At the DGfW Conference, a DGfW and EWMA co-organized session, led by Martin Koschnick, took place highlighting the education in wound management in Europe. Due to the fact that national education models in wound healing and wound management are quite different, the basic idea was to present a broad variety of these different models. These models or teaching systems range from University-based systems, to teaching offered by ‘private institutions’. EWMA plays a special role in education. This role was presented by Zena Moore, President of

EWMA, in the session “EWMA’s Role in International Education”. She pointed out that EWMA can bridge different European countries by initiating and endorsing courses focused at education in wound healing and wound management. At the annual EWMA congress a University Conference Model for student nurses provides access to education in wound healing and wound management. Luc Gryson, President of the Belgian Federation of Wound Care and teacher at HUB-EHSAL University College in Brussels, presented in his speech: “A university based post graduate nursing education in wound healing and wound therapy”, the ‘Belgian Way’ of wound healing education. In addition to universities in Belgium, universities in a lot of European countries offer educational courses in wound healing. This is probably the predominant way of teaching in Europe. Students can use the ECTS (European Credit Transfer System) to transfer teaching units from one university to another within Europe. A special university-based model was presented by Edda Johansen from Norway, main organizer of a flexible learning course in wound management in Norway, which includes a strong component of web-assisted learning. Compared to many other courses this type of course does not fix the student to a rigid curricular structure, and therefore allows enforcement of the particular skills and strengths of each student. The inclusion of web-based teaching and technology was presented as an excellent addition to teaching methods illustrating how training adapts to include current actual technology making it more accessible and easy to understand. Steve Strupeit from Germany presented “The DGfW Curriculum”, which is a curriculum-controlled course for both physicians and nurses offering worldwide recognised certification according to ISO 1704 in the private market. Teaching is organized by private companies according to the guidelines set by DGfW in the accreditation process. In comparison to university institutions, the private education sector can react quicker and allows a rapid spread of the Curriculum all over

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Organisations

lation, and aftercare such as specialized beds be addressed in a more holistic approach. Practical recommendations in pressure ulcer flap surgery included proper drainage over at least 5-7 days, sutures remaining for at least 21 days, and no pressure on the flap or the suture line for 2-3 weeks.

Germany and potentially further growth into other European countries. In the last speech of the session Undine Soltau from Germany (board member of the Central Organisation for Health Protection, Medicaments and Medical Products for the German States) presented the changes of the EU regimentations and offering in teaching wound therapy and wound management. The main aspect, in terms of EU laws changes, is the elevated importance of accreditation set by the EU Commission. This has resulted in a slightly changed organisational structure of the process which allows a better harmonisation between European countries. In overall terms the session pointed out quite clearly, that there are big differences of teaching in wound healing and wound management all over Europe and that it is nearly impossible to rate the different systems.

Other key conference presentations Up to 11 parallel sessions with lectures, poster presentations, workshops, physician and patient forums as well as case presentations and seminars were offered to the participants. The scientific program emphasized the role of surgeons in wound care, highlighted evidence-based care in pressure ulcer treatment, and explored the surgical options offered by plastic reconstructive surgeons. There was consensus that

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gluteal regional muscle flap surgery is a valid and durable option for sacral pressure ulcers. Both gluteal muscle and hamstring muscle flaps are appropriate solutions for ischiadic pressure ulcers. The tensor fascia lata flap on the other side is recommended for coverage of trochanter pressure ulcers. In addition to the conventional pedicle, aforementioned musculocutaneous free flap surgery has been presented in selected cases. While issues such as target vessels in the surrounding of a pressure ulcer and microsurgical anastomosis might be challenging, the latissimus dorsi flap for example might be a considerable option in selected patients with good mid-term clinical results. All plastic reconstructive surgeons reached consensus that, prior to defect coverage, a comprehensive assessment and optimization of nutrition, sepsis, coagu-

General and abdominal surgeons emphasized the use of vacuum therapy in the treatment of the open abdomen especially in severe peritonitis with serial lavage procedures. In pseudomonas infections, there is limited success of vacuum therapy given the hydrophilic nature of the germs. Topical vitamin C might be a reasonable approach in order to lower pH in this regard. Once the closure of the abdominal fascia is impossible, cellular dermis substitutes might potentially be the appropriate measure enabling abdominal closure. However, at best prospective randomized-controlled trials are warranted in this regard. In sternal osteomyelitis radical debridement and early cooperation of thoracic and plastic surgeons are key. Osteomyelitis of long bones is apparent with some 1.500 cases per year in Germany. Still, these cases are highly expensive with about 700.000 Euro per case for healthcare and working absence. Once again radical serial debridement with exchange of hardware and targeted antibiotic therapy are key factors for success. However, even multiple tissue biopsies will not always identify the major causitive bacteria. m

The upcoming DGfW Conference will be hosted in Hannover, Germany, 23-25 June 2011 under the auspices of Professor Dr. Peter M. Vogt (Hannover), the current president of DGfW. Abstract deadline is December 15, 2010. All abstract submissions can be made via www.dgfw.de and international abstract submissions are more than welcome for this upcoming event! Travel grants for young scientists can be applied for. Poster, case report and experimental work prizes are given in connection with the DGfW Conference. All accepted abstracts will be published in German “Zeitschrift für Wundheilung”, www.dgfw.de/index_4_zfw.html.

Organisations

Cooperation between WMAS and EWMA WMAS Wound Management Association Slovenia

Nada Kecelj Leskovec, MD, PhD Dermatology Dpt., University Medical Centre Ljubljana, Slovenia www.dors.si

This article is based on the reflections made when preparing a presentation for the meeting of the EWMA Cooperating Organisations Board during the Geneva conference. It aims to consider the benefits of the cooperation between WMAS and EWMA and points to some key aspects of the cooperation. Under EWMA’s umbrella WMAS has made significant progress during recent years. We got a lot of very interesting and useful information about work, research and education in the field of wounds together with valuable expert support. We also had the opportunity to meet a lot of very nice people, to work together, and to join our ideas, knowledge and experiences to improve our services in wound care. The Wound Management Association of Slovenia The Wound Management Association of Slovenia (WMAS) was established in 2001 at University Clinical Centre in Ljubljana, the capital of Slovenia. It joins together different professionals (doctors, nurses, pharmacists and local distributors) working with chronic wounds all over Slovenia. We are all working together with one final goal, namely that of making wound management and therapy more successful and the quality of patients’ life better. By collecting new data, exchanging our own experiences, educating medical staff and patients, we try to introduce and implement new guidelines in practice. We also negotiate with the Health Insurance Institution and the Ministry of Health for reimbursement of dressings and compression materials.

Members of WMAS after Symposium about Venous and Pressure Ulcers, Bled, April 2005.

Meeting between EWMA and WMAS representatives, Ljubljana, December 2007.

WMAS has an internet page with a variety of very useful information. Please visit it on www.dors.si and also view the WMAS introduction film. During the last ten years WMAS members have been very busy. We have organised Symposiums with workshops two to three times per year, for which we also invited speakers from EWMA. Zena Moore was in Catež in 2008 and Luc Gryson at Bled in 2009, both visits giving us a lot of new and useful information. With the permission of the EWMA Council all EWMA Position Documents were translated into Slovenian by WMAS members. The documents were presented at the WMAS symposium in Moravske Toplice in October 2007 and had a significant influence on implementation of new Slovenian guidelines in practice. The Leg Ulcer Project The largest leg ulcer study ever undertaken in Slovenia has been carried out by WMAS with support from EWMA and is almost finished. Many WMAS members have spent their free time and weekends to accomplish this job and it has been possible only because of these highly motivated professionals committed to their work. During the process we have had meetings in Slovenia with the scientific lead of the project, Prof. Peter Franks and staff from the EWMA Secretariat, who helped us both in planning the project and processing the data. In the first phase (identification) the prevalence of all wounds in the Dolenjska region was estimated at 1.8/1000. In second phase (education), the medical staff that cooperated in 1st phase of LUP was additionally educated according to the guidelines of WMAS and EWMA. They had lectures on all kinds of chronic wounds and workshops (ABPI workshop, compression workshop, local wound therapy workshop). They sat the same exam at the

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beginning and at the end of education and it was apparent that their level of knowledge was significantly improved. In the third phase (implementation) all included patients from the first phase and new one were re-assessed in outpatient clinics in Novo Mesto and Crnomelj. New wound therapy was advised according to WMAS and EWMA guidelines. We are awaiting the results about new prevalence.

ELECTRONIC SUPPLEMENT OCTOBER 2010

In April 2008 Deborah Hoffman from EWMA visited Ljubljana to coordinate WMAS guidelines for wound treatment and to help us prepare the program for the 2nd phase of LUP. The first WMAS guidelines for wound treatment with modern dressings were edited in 2009. WMAS Publications and Advocacy for Reimbursement EWMA representatives helped us to negotiate with Slovene Health Insurance Institutions and the Ministry of Health about reimbursement for dressings and compression material. We were already successful in the area of compression stockings for lymphoedema, partly on the area of dressings for chronic wound and we are still negotiating for reimbursement for short stretch compressing bandages for patients with venous leg ulcers. We have also edited brochures for patients about compression, venous, pressure and diabetic ulcers and are planning to prepare the new handbook about acute and chronic wounds in Slovenian soon. WMAS members attended EWMA congresses every year. We presented different interesting topics about wounds both as speakers and with poster presentations. We have also presented results from the Leg Ulcer Project (LUP) in Slovenia. WMAS appreciates EWMA’s continued support and is keen to cooperate with the other Cooperating Organisations in the future. We are interested in being involved in international educating teams for chronic wounds all over the Europe. We are also prepared to organise such international educating courses in Slovenia. We are willing to be involved in different international studies about wounds with the aim of improving our knowledge and making our patients’ lives better. m

The October 2010 edition of the EWMA Journal Electronic Supplement consist of five scientific articles from the Italian journal Acta Vulnologica, which have not previously been published in English:

n Normothermic

treatment of pressure ulcers: reliminary results of the first Italian multicenter p randomized trial

M. Romanelli, C. Brilli, R. Panii, E. Ricci, A. Scalise, U. Bovone, A. Richetta, C. Fabbri, D. Hanna n Clinical

and Economic impact of a community outpatient Wound Care Centre

P. Longobardi, E. Piccinini, D. Poddie, B. Caruso, F. Laghi, A. Aimola, A. Zappi, E. Di Ruscio, T. Carradori n Comorbidities

in aged patients with leg ulcers

M. Gonella, E. Martinelli, E. Ricci n Psychological

skin lesions

support in the treatment of chronic

M. Boggio Marzet, K. Somà, S. Furlini n Compression

therapy in patients with reduced mobility following thopic lesions of the lower limbs

G. Mosti

www.ewma.org/english/ewma-journal/ electronic-supplement.html

WWW.EWMA.ORG

Organisations

WMS (Belarus) Wound Management Society

Leonid Rubanov The head of the centre of a burns trauma, wounds, wounds infection and reconstructive surgery. Chairman of public association “Wound Management Society”

Rytis Rimdeika President of the Lithuanian Wound Management Association LWMA. EWMA Council member

Thomas Wild (Austria)

Wound Management Society officially registered in Belarus In March, 2010, in Gomel, the second largest city of the Republic of Belarus, the international conference “Modern Technologies in Management of Wound and Wound Infections” was organised by the public association Wound Management Society and Health Service Administration of the Gomel Region under the patronage of Health Ministry of the Belarus Republic. This conference highlighted the official recognition of the public association Wound Management Society in the Republic of B elarus, but in addition, this was also a result of the acceptance of the Resolution on Promotion of Modern Wound Dressings and Novel Techniques of Wound Treatment in the Republic of Belarus. It was also an introduction to the newest techniques in wound treatment and surgery, and prevention of wound infections. The European Wound Management Association, EWMA, supports local initiatives targeted at the establishment and construction of national wound management societies. The EWMA Council has appointed its member, Rytis Rimdeika, who is also the President of the Lithuanian Wound Management Association to support and promote these activities in the Eastern European countries and Russia.

Rytis Rimdeika and Leonid Rubanov with guests.

(Ukraine), Rytis Rimdeika (Lithuania, EWMA) and Thomas Wild (Austria). More than 200 nurses and doctors from many regions of the Republic of Belarus and other countries (Lithuania, Latvia, Austria, Ukraine and Russia) participated in the conference. Participants from these regions presented papers and case reports from their clinical practice, while workshops on modern wound care techniques were also successfully run alongside the sessions.

The conference program included three thematic sessions: wound care and debridement, surgical wound management, and modern trends in management of wound and wound infections as well as a variety of reports.

Exhibitions of modern wound dressings, the wound care equipment, medical devices and current pharmaceutical products took place during the conference. Well known international and local manufacturers including Hartmann, Lohmann & Rauscher, Smith & Nephew, Gedeon Richter and Lenta Public Corporation were represented at this exhibition.

The conference was visited by international speakers Boris Paramonov (Russia), Dr. Emil J. Festal

Organisers of the conference would like to thank all the sponsors for their contribution. m

Boris A. Paramonov (Russia)

Dr. Emil J. Festal (Ukraine) EWMA Journal

2010 vol 10 no 3

EWMA DOCUMENTS In May 2010 the following EWMA Document was published:

Outcomes in controlled and compara tive studies on non-healin g wounds Recomm

Outcomes in controlled and comparative studies on non healing wounds – Recommendations to improve q uality of evidence in wound m anagement The document is written by members of the EWMA Patient Outcome Group, based on common discussions in the group.

endations to improve the of evidence in quality wound manag ement

A EWMA Patie

nt Outcome G

roup Documen

EWMA front cover.

indd 5

20/5/10 13:14: 26

Other EWMA documents e.g. Position Documents can be downloaded from www.ewma.org and are available in English, French, German, Italian and Spanish. It is possible to obtain permission to translate the EWMA Documents into other languages. Please contact EWMA Secretariat for permission. Please note that the EWMA Position Documents express the view of EWMA at the time for publication of the document. Titles of Position Documents: Pain at wound dressing changes – Spring 2002 Understanding compression therapy – Spring 2003 Wound bed preparation in practice – Spring 2004 Identifying criteria for wound infection – Autumn 2005 Management of wound infection – Spring 2006 Topical negative pressure in wound management – Spring 2007 Hard-to-heal wounds: a holisitc approach – Spring 2008

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For further details contact: EWMA Secretariat, Martensens Allé 8, 1828 Frederiksberg, Denmark Tel: +45 7020 0305 Fax: +45 7020 0315 ewma@ewma.org

Cooperating Organisations AFIScep.be Francophone Nurses’ Association in Stoma Therapy, Wound Healing and Wounds

AISLeC Italian Nurses’ Association for the Study of Cutaneous Wounds www.aislec.it

AIUC Italian Association for the study of Cutaneous Ulcers www.aiuc.it

APTFeridas Portuguese Association for the Treatment of Wounds www.aptferidas.com

AWA Austrian Wound Association www.a-w-a.at

BEFEWO Belgian Federation of Woundcare www.befewo.org

BWA Bulgarian Wound Association

GNEAUPP National Advisory Group for the Study of Pressure Ulcers and Chronic Wounds www.gneaupp.org

ICW Chronic Wounds Initiative www.ic-wunden.de

LBAA Latvian Wound Treating O rganisation

LUF The Leg Ulcer Forum www.legulcerforum.org

LWMA Lithuanian Wound Management Association www.lzga.lt

MASC Maltese Association of Skin and Wound Care

MSKT Hungarian Wound Care Society www.euuzlet.hu/mskt/

CNC Clinical Nursing Consulting – Wondzorg www.wondzorg.be

MWMA

CSLR

Macedonian Wound Management Association

Czech Wound Management Society www.cslr.cz

NATVNS

CWA

National Association of Tissue Viability Nurses, Scotland www.natvns.com

Croatian Wound Association www.huzr.hr

NIFS Norwegian Wound Healing Association www.nifs-saar.no

DGfW German Wound Healing Society www.dgfw.de

NOVW

DSFS

Dutch Organisation of Wound Care Nurses www.novw.org

www.dsfs.org

PWMA

FWCS

Polish Wound Management Association www.ptlr.pl

Finnish Wound Care Society www.suomenhaavanhoitoyhdistys.fi

ROWMA

GAIF

Romanian Wound Management Association www.artmp.ro

Danish Wound Healing Society Danish Wound Healing Society

Associated Group of Research in Wounds www.gaif.net

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2010 vol 10 no 3

Organisations

SAfW

SWHS

Swiss Association for Wound Care www.safw.ch www.safw-romande.ch

Swedish Wound Healing Society www.sarlakning.se

TVS

SAWMA Serbian Advanced Wound Management Association

SEBINKO Hungarian Association for the Improvement in Care of Chronic Wounds and Incontinentia www.sebinko.hu

SFFPC The French and Francophone Society of Wounds and Wound Healing www.sffpc.org

Tissue Viability Society www.tvs.org.uk

URuBiH Association for Wound Management of Bosnia and Herzegovina

V&VN Decubitus and Wound Consultants, Netherlands www.venvn.nl

WMAOI

SSiS Swedish Wound Care Nurses Association www.sarsjukskoterskor.se

Wound Management A ssociation of Ireland www.wmaoi.org

WMAK Wound Management Association of Kosova

SSOOR Slovak Association for Wound Care www.ssoor.sk

WMAS Wound Management Association Slovenia

SUMS

WMAT

Iceland Wound Healing Society www.sums-is.org

Wound Management A ssociation Turkey www.yaradernegi.org

SWHS Serbian Wound Healing Society www.lecenjerana.com

WMS (Belarus) Wound Management Society

International Partner Organisations AWMA

Debra International www.debra-international.org

NZWCS

AAWC

ILF

SOBENFeE

Association for the Advancement of Wound Care www.aawconline.org

International Lymphoedema Framework www.lymphoedemaframework.org

Brazilian Wound Management Association www.sobenfee.org.br

Australian Wound Management Association www.awma.com.au

New Zealand Wound Care Society www.nzwcs.org.nz

Associated Organisations

EWMA Journal

Leg Club

LSN

Lindsay Leg Club Foundation www.legclub.org

The Lymphoedema Support Network www.lymphoedema.org/lsn

2010 vol 10 no 3

For more information about EWMA’s Cooperating Organisations please visit www.ewma.org

Science, Practice and Education 5 Rationale for compression in leg ulcers with mixed, arterial and venous aetiology Hugo Partsch

10 Pressure ulcers in Belgian hospitals: What do nurses know and how do they feel about prevention?

D. Beeckman, T. Defloor, L. Schoonhoven, K. Vanderwee

13 Nutritional Supplement is Associated with a Reduction in Healing Time and Improvement of Fat Free Body Mass in Patients with Diabetic Foot Ulcers P. Tatti, A.E. Barber, P. di Mauro, L. Masselli

21 Chronic wounds, non-healing wounds or a possible alternative? M. Briggs

25 Silver-impregnated dressings reduce wound closure time in marsupialized pilonidal sinus A. Koyuncu, H. Karadaˇ, A. Kurt, C. Aydin, O. Topcu

29 Venous leg ulcer patients with low ABPIs: How much pressure is safe and tolerable? J. Schuren, A. Vos, J.O. Allen,

36 Adherence to leg ulcer treatment: Changes associated with a nursing intervention for community care settings

A. Van Hecke, M. Grypdonck, H. Beele, K. Vanderwee, T. Defloor

Background Article 38 A Social Model for Lower Limb Care: The Lindsay Leg Club Model M. Clark

EBWM 42 Abstracts of recent Cochrane reviews S. Bell-Syer

EWMA 46 EWMA Journal and International Journals 48 The EWMA Patient Outcome Group F. Gottrup, J. Apelqvist, P. Price

56 Introducing the EWMA Master Course Z. Moore

58 The EWMA UCM L. Gryson, Z. Moore

60 EWMA 2010, Geneva S. Bale

64 Appreciations 65 EWMA Activities Update 66 The Cooperating Organisations Board Meeting M. Romanelli

68 Corporate Sponsor Contact Data

Organisations 70 Calendar 71 13th EPUAP Meeting in Birmingam, UK T. Young, A. Gefen

72 Report from the 13th annual meeting of DGfW K. Knobloch, M. Koschnick

74 Cooperation between WMAS and EWMA N. K. Leskovec

76 Wound Management Society o fficially registered in Belarus L. Rubanov, R. Rimdeika

78 Cooperating Organisations Electronic Supplement October 2010: ewma.org / english / publications / ewma-journal / electronic-supplmnt.html