EWMA Journal Spring 2005

tischen Fußes. Die Rezidivrate nach d e r Ab h es diabe d a r e eilun Ulz e f g dia e i dt beti ßb n u sche e x le p rU m o lzer k s l a is da t be n i s kan Volume 5 ten auch bei komplizierten Ulzer en ra s t g n s n tl u il a e a f h ü l Number 1 b hrt. L ich A n nt e e r e d e iglic seh Spring 2005 u ess b z h h die tiv tlic u G k e ePublished e d fah by zu e ff r vo de European n n en Dru Wu ) als signifikante Faktoren f Wound Management cks er inteilung ür ein E d e n e ver g Association telle eige n ( z e ö u gert ni und ter eH st ns er W e be e d i l u F d n ib gn ra it g r es e m e u nt e tie n a m P t i w t or s chronisc ro p en d e d r ch e h s w e S a n p Wun thi n weile den sc h Gi de ittler M n d er . a n e c h d u r Ul fes u e w ze ten et öß ra r en ti a d P te n n e k o h S c ll s n e g ti k e t t i v b ü a e be d s mit nd s dia gr e n e n i re un ard euro g ge c ) n p u s s a r h t c i hisc nt u to s r c e e h t rd en Fa Un der weiterhin hohen Am isz Ulz g te fgrund p ip u in ß e u a tatio d ö r r li i a r w g nsra w s e g u ß t n u e r de von la nF vo he kennung und werden in de b is u r e c n n s A n ter r nä le eti a c n s b h o c i s t a ten hie i rn a Ze sd dli nte n zu verifizieren. So ko o i i i t t c de a nnte pu en valu E d b z e . l n izi B. fa lich er im itende Wundsprechs aft t rk e b W h r a tund c r u s ä n n n i e l dn nk e zip ss on et Wundmanagement dis e wi r n n r e t e h t e d a n t in in mo in De ue as e Gelegenheit ergr i d D u e e l . l i t fen sc Ste en lu un er undhei ng Studien s d W e r d du di de rch auf spekulativen et i e t b pa g p ze t prospektiv on el an e Erfa en un ho h hru d ng önlic ng s r Es .M

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EWMA Council The EWMA Journal ISSN number: 1609-2759 Volume 5, No. 1. Spring, 2005 The Journal of the European Wound Management Association Published twice a year Editorial Board Carol Dealey, Editor Michelle Briggs Finn Gottrup Sylvie Meaume E. Andrea Nelson Sue Bale Peter Vowden

3 Editorial Carol Dealey

Scientific Articles Christine Moffatt Immediate Past President

Peter Vowden President

Peter Franks President Elect

Stephan Coerper

10 Vascularized Bone Replacement for the Treatment of Chronic Bone Defects – Initial Results of Microsurgical Solid Matrix Vascularization

EWMA Homepage www.ewma.org For membership application, correspondence, prospective publications contact: EWMA Secretariat PO Box 864, London SE1 8TT United Kingdom Tel: +44 207 848 3496 ewma@kcl.ac.uk

Enquiries concerning advertising should be addressed to: Congress Consultants Martensens Allé 8 DK-1828 Frederiksberg C · Denmark.

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F. Petrella

Marco Romanelli, Madeleine Flanagan

Background Article

32 Article Review Sue Bale Sue Bale

Carol Dealey EWMA Journal Editor

Madeleine Flanagan

EBWM

34 Abstracts of Recent Cochrane Reviews Sally Bell-Syer

35 Selected abstracts from 2nd World Union of Wound Healing Societies meeting EWMA Katia Furtado

Deborah Hofman

Luc Gryson

The contents of articles and letters in the EWMA Journal do not necessarily reflect the opinions of the Editors or the European Wound Management Association.

The copyright of all published material and illustrations is the property of the European Wound Management Association. However, provided prior written consent for their reproduction is obtained from both the Author and EWMA via the Editorial Board of the Journal, and proper acknowledgement made and printed, such permission will normally be readily granted. Requests to reproduce material should state where the 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.

2

36 EWMA Educational Panel Madeleine Flanagan

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 Fall 2005. Prospective material for the publication must be with the editors as soon as possible and in no case later than 1st June.

16 The Importance of Family and Domiciliary Treatment of Immobile Patients with Chronic Wounds 22 After TIME: wound bed preparation for pressure ulcers

Layout: Birgitte Clematide Printed by: Kailow Graphic A/S, Denmark Copies printed: 10,000

4 Wound Healing and Wound Treatment 2004 – the current state

37 Call for Registration of all Clinical Trials 40 EWMA Journal Previous Issues 40 International Journals 42 EWMA Author Guidelines Zena Moore

E. Andrea Nelson

Javier Soldevilla

43 EWMA Corporate Sponsor Contact Data Conferences

44 Conference Calendar

Carolyn Wyndham-White

For contact information, see www.ewma.org

Organisations

45 PWMA Wound Management in Poland – facing challenges of XXI century Zbigniew Rybak, Wojciech Stras

Panel Members (not on council) Co-operating Organisations’ Board Helen Orchard Leif Aanderud Helena Peric Andrea Bellingeri Ralf-Uwe Peter Katia Furtado Zbigniew Rybak Finn Gottrup Javier Soldevilla Aníbal Justiniano Luc Tèot Bernadette Kerry Rosine Van Den Buclk Iveta Lankovska Marie Melicharová Carolyn Wyndham-White Gerald Zöch

47 Poland Educational Panel Christina Lindholm Hugo Partsch Cost-effectiveness Panel Elia Ricci John Posnett Nick Bosanquet Patricia Price

48 DGfW 49 IWHS Samtök um Sárameðferð Guðbjörg Pálsdóttir

50 Co-operating Organisations

Editorial Board Michelle Briggs Sylvie Meaume

EWMA JOURNAL

2005 VOL 5 NO 1

Editorial

W

elcome to this edition of the EWMA Journal. As usual it is an eclectic mixture of scientific and clinical papers, EWMA news and information from our co-operating organisations. This issue sees a special focus on Germany in preparation for our joint conference with the European Tissue Repair Society (ETRS) and the Deutsche Gesellschaft für Wundheilung (DGfW) in September 2005. Within the journal there is a paper from Professor Horch’s group at the University of Erlangen Medical Center presenting their work on vascularisation of solid preformed bioartificial bone grafts. This type of work has the potential for improving the treatment of bone defects and improving outcomes for patients, especially following head and neck surgery. The paper by Coerper et al is an informative review of the status of wound healing knowledge from both the German and wider perspective and allows us a greater understanding of some of the research activity in Germany that is normally denied to those who do not read German.

Information about the different co-operating organisations within Europe is always of interest and this issue is no different as we have updates about activities in Poland and Iceland as well as the DGfW in Germany. These updates demonstrate how EWMA has played a major role in helping smaller organisations to get established and it has become an important aspect of the Society’s activities. The DGfW is a well-established organisation having been founded in 1994 and has it’s own bimonthly journal Journal of Wound Healing /Zeitschrift für Wundheilung.

Finally, I would like to draw readers’ attention to the important document on the reporting of clinical trials from the International Committee of Medical Journal Editors (ICMJE) on page 37. For the purposes of their proposal they define a clinical trial as a prospective controlled trial of humans to study the cause and effect relationship between a medical intervention and a health outcome. The ICMJE put forward the case that all trials should be registered on a public registry upon commencement.

The ICMJE suggest that at present it is possible to suppress study findings if researchers or their sponsors so wish, in part because there is a general reluctance to write or publish negative findings (where standard treatment is superior to the new treatment) or studies where there is no clear outcome.

They call for editors of other biomedical journals to encourage the registration of new clinical trials by making it a pre-condition of publication. This is now the policy of all their member journals and applies to any clinical trial that starts enrolment after July 2005. The Editorial Board of the EWMA Journal have also agreed to require authors to confirm that they have registered their study for any clinical trial that commences enrolment after September 2005, recognising that study completion is likely to be some time in the future. However, the concept of transparency in research is important and we wish to endorse this first step to improving the situation.

Carol Dealey, Editor

EWMA JOURNAL

2005 VOL 5 NO 1

3

Scientific Article

Compendium

Wound Healing and Wound Treatment 2004 – the current state This paper was first published in German in Zeitung für Wundheilung in 2004 vol 9;1: 20-23. It is reproduced here by kind permission of the Editor.

Stephan Coerper PD. Dr. med and G. Gottwald, S. Beckert and H. D. Becker Correspondence to: Chirurgische Univ. Klinik Tübingen, Klinik für Allgemeine Chirurgie, Hoppe-Seyler Str. 3, 72076 Tübingen Germany stephan.coerper@ med.uni-tuebingen.de

4

Summary: Numerous new methods of wound treatment and wound dressings were launched during the last years. Some products became widely accepted while others disappeared. An analysis of scientific studies about products used at present revealed 13 studies with the evidence grade Ib and a large number of studies investigating the practicability of wound care products. In this overview we discuss the recent scientific situation of wound care in Germany.

Keywords: Wound treatment, Studies, Overview

INTRODUCTION There is hardly any other medical field that is influenced by personal experiences and assessment to such a high degree as wound treatment. The lack of prospective and controlled studies regarding wound healing often leads towards a tendency to base treatment concepts on speculative pathophysiological considerations. However during the last years, studies were carried out in the field of wound healing which live up to the high level of scientific requirements. We would like to use this opportunity to show those studies that – in our opinion – are important and show the recent state of science in wound healing.

Modern wound management has gained further importance in Germany. Patients with badly healing wounds have found access to bigger (wound-) centres, and numerous new interdisciplinary working wound centres have been established in hospitals. Different initiatives are now trying to organise the treatment of those problem wounds following common standards and verifying them by scientific evaluation.

That way a standardised treatment in different centres was documented in Wundnetz.e.V. For this purpose a special wound documentation system has been established. The first data of this

scientific network is acknowledged internationally and has been published recently.4 By means of a comprehensive patient group it was proved that compliance, severity and age of the patients have a crucial influence on the healing of chronic wounds.

NEW CONCEPTS FOR DIVERSE CLINICAL PICTURES Due to the high amputation rate the clinical picture of the diabetic foot is still studied by various medical disciplines. The introduction of the Disease Management Programme was one of the reasons for the diabetic foot to gain importance.

Regarding the diabetic foot there are some very interesting studies on epidemiology, on prognosis factors and new treatment regimes.

So far the biggest analysis of a diabetic patient group with neuropathic ulcers has been published

by Margolis 2002.10 Here a patient group of more than 31,000 patients has been examined. These patients have been treated in a network of wound healing centres since 1988. Primarily this centre has been founded by Curative Technologies to market the autogenic growth factor concentrate PDWHF (Platelet Derived Wound Healing Factors).

Patients with chronic wounds are treated at this centre by an interdisciplinary team following fixed standards and their medical history is documented – the growth factors only play a minor role. Anyhow during the assessment of this data it should never be forgotten that the industry could have an influence on the data and that it is not an independent scientific study.

Based on the size of the patient group Margolis was able to calculate the wound duration, the wound size, and the wound severity (own allocation) as significant factors for a delayed healing of neuropathic ulcers. The pressure relief of neuropathic ulcers is a central pillar of the therapy concept. The mode of pressure relief is still discussed. In the USA and Great Britain pressure 䊳 EWMA JOURNAL

2005 VOL 5 NO 1

Excellence in Education EUROPEAN WOUND INSTITUTE

The European Wound Institute is Europe´s first accredited centre for wound therapy, embedded in the ESI, one of the world most modern centres for continuing medical education.

In Cooperation with

ETHICON GmbH · Johnson & Johnson Wound Management · Oststraße 1 · D-22844 Norderstedt · eMail: mservic2@medde.jnj.com

Scientific Article

relief via a total contact cast is very common. In earlier studies advantages of the total contact cast could have been observed compared to the off loading heel/shoe.1 In 2003 a prospective study was published which showed that with using a non-removable, windowed, fibro glass cast boots the healing rates are much higher even if dealing with complicated ulcers. The danger of new pressure ulcers caused by the boot should not be underestimated given a present neuropathy. In the quoted study of Ha Van it was relatively high reaching a level of 10%.8 In opposition to those results a study carried out by Zimny with 54 patients showed that a felted foam shoe inlay could cause results nearly as good as those of a off loading heel/shoe.20 However, only patients with very small neuropathical ulcers have been included in this study.

It can be concluded that smaller, superficial ulcers can be effectively relieved using much simpler measures. This is not the case in complex and deep diabetic foot ulcers.

It is known that the recurrence rate after a diabetic ulcer healing is very high. Two studies have recently dealt with this subject: Paola has studied the recurrence rate of the first ray and found a relatively low recurrence rate (15/89 after 16 months) compared to the literature. He concluded that this was due to a good and consequent aftercare in terms of tertiary prevention.14 A very interesting approach is the Achilles tendon extension to relieve the forefoot of neuropathic forefoot ulcer.13 This procedure is justified by the diabetic motor neuropathy that leads to a foreshortening of the tendons in the foot. This leads to a slight Pes Equinus position and a higher exposure of the forefoot. By operatively extending the Achilles tendon Mueller was able to show significant reductions of the recurrence rate after seven months (p=0,001) as well as after two years (p = 0,002). A control group was used which did not undergo an operation.

Due to its chronic venous insufficiency the venous ulcer is still the most frequent aetiology of non-healing chronic wounds. In treating venous ulcers one of the fundamental therapeutic measures is certainly the compression therapy.

But still the compression mode is unclear.

Moffatt et al. published a controlled, prospective study regarding this question. She compared two different elastic compression-dressing systems: The two-layer bandage system (Surepress) and the four-layer bandage system (Profore). After 12 weeks the healing rate had been found significantly better using the four-layer bandage system (p = 0,02). Furthermore a distinct cost reduction was reached which can be explained by the lower amount of dressing changes including the compression readjustment.12 Besides compression, surgical venous rehabilitation was regarded to be a very important measure to influence the healing and recurrence rate of venous ulcers. Here the Subfascial Endoscopic Perforator Surgery (SEPS) plays a 6

major role. Two studies analysed the importance of SEPS based on large patient groups9,2: Within three months Bianchi observed a healing rate of 91% in his patient group (n = 74) after using SEPS. After 30 months the recurrence rate was at a level of 6%. After successful operative rehabilitation of venous insufficiency by means of SEPS Lafrati observed a healing rate of 74% within six months and after five years a recurrence rate of 13% (n = 51).2

WOUND TREATMENT For years and years, new dressings have been introduced to the market. But preliminary clinical studies regarding this matter are, in the majority of cases, not available.

On the other hand, the protease regulating wound dressing, Promogran, was proved effective via different studies. An experimental work proved that protease activity within wound liquids is significantly reduced by using this specific dressing.5 After Veves was able to show the effect of Promogran on diabetic ulcers, a prospective and randomised study on patients with venous ulcers is now underway. By means of a patient group (n = 73) Vin et al. were able to show that Promogran leads to a significantly faster reduction of the ulcer surface, even if the total healing rates only showed a trend in favour of the product.20 In comparison to the conventional therapy the application of a hydro-gel seems to significantly stimulate wound healing. It is presumed to be caused by a hydrolytic debridement. This is concluded in Smith’s meta-analysis, published at the Cochrane databank.17 Bigger controlled, prospective studies dealing with this subject have not been published recently.

The question to what extent wound rinsing can have an influence on wound healing or wound infection is the subject of another analysis. Griffiths et al. have undertaken a randomised and prospective wound rinsing with aseptic salt and tap water among 49 patients and found no difference in healing or infection rate.7 For years and years it has been tried via physical methods to accelerate wound healing. There are not many new observations to be made regarding hydrotherapy. Still, this form of wound cleaning is only supported on an empirical basis, corresponding studies are still missing.

The same applies for ultrasonic treatment. Within this field the pathophysiological principle of “Caviation” with change of cell membrane and consecutive enhanced wound healing could not have been proven by means of studies.

Only one controlled and prospective study regarding electrical stimulation on diabetic ulcers has been carried out so far. It is published by Peters et al.15 On the basis of 40 patients suffering from diabetic ulcers it was shown that application of minor currents during the night signifi䊳 EWMA JOURNAL

2005 VOL 5 NO 1

3M Foam Adhesive heel Dressing Genbrug fra EWMA Journal 2/2004

Scientific Article

cantly stimulates wound healing. A group where the currents were controlled by a microcomputer and a placebo group were used for comparison.

Hyperbaric oxygenation in special pressure chambers is still under discussion. No convincing, controlled studies have been brought forward yet.

In many centres the V.A.C. therapy is part of the therapy concept. Numerous new case reports and application observations have been published. Meanwhile a controlled clinical study has been published by Scherer.16 By means of 61 patients it has been shown that using VAC therapy significantly improves the healing rate of split skin grafts.

However, another controlled study on 41 decubitus ulcers did not show significantly improved wound healings.6

INNOVATIVE PRACTICES In principle the great enthusiasm connected to growth factors has been let down. Only one single growth factor, the PDGF-BB (Regranex) was shown to be effective in controlled studies. Now one further growth factor – EGF (Epidermal Growth Factor) has successfully been tested on diabetic ulcers. A controlled and prospective study of 61 patients showed that the local application of rhEGS (applied and allotted as a spray) in a dose rate of 0,04% (wt/wt) lead to a significantly faster healing . No side effects were observed.18 However those growth factors have been clinically analysed in the past without big success.

Certainly one has to wait and see if these new results can be affirmed by further studies.

Within the field of Tissue Engineering, a further study regarding the product Dermagraft has been published.11 Here human fibroblasts are cultivated on a re-absorbable mesh and cryo preserved. In this multi-centre study on 314 patients with diabetic ulcers a significant higher healing rate – compared to a control group – (p = 0,023) could be shown after application of Dermagraft.

Finally we would like to introduce a completely new approach towards stimulation of wound healing. For a long time it has been known that nitrogen oxide (NO), an ephemeral gas, is able to regulate and stimulate major wound healing processes. An experimental study proves that the local application of a hydro-gel that releases NO significantly stimulates wound healing in rats.3 It remains to be seen to what extent additional experimental studies will lead to the first clinical test of this new principle.

CONCLUSION Despite the complexity of chronic wounds it is possible to carry out reasonable studies if those planned are suitable.

This has been shown recently. However, those studies are of course expensive and, due to a lack of infrastructure in Germany and the other European countries, hard to

8

organize. Competent networks are probably able to call up such a structure to be able to test innovative products in Germany and throughout Europe.

To establish comprehensive, scientifically based concepts we still have insufficient knowledge. As yet only some aspects can be looked upon as scientifically proved.

Furthermore it has to be emphasised that not only should the examination of medical products be of major concern but that the evaluation of contexts, custodial aspects and 䡵 patient compliance are also important subjects.

Literature 1. Armstrong DG, Nguyen HC, Lavery LA, Carine HM, Boulton AJM and Harkless LB: Off-loading the diabetic foot wound. a randomized clinical trial. Diabetes Care 2001; 24: 1019-1022.

2. Bianchi C, Ballard JL, Abou-Zamzam AM, and Teruya TH: Subfascial endoscopic perforator vein surgery combined with saphenous vein ablation: Results and critical analysis., J Vasc Surg 2003; 38: 67-71.

3. Bohl Masters KS, Leibovich J, Belem P, West JL, and Poole-Warren LA: Effect of nitric oxide releasing poly (vinyl alcohol) hydrogel dressings on dermal wound healing in diabetic mice., Wound Rep Reg 2002; 10: 286-294.

4. Coerper S, Wicke C, Pfeffer F, Köveker G and Becker HD: Documentation of 7051 chronic wounds with a new computerized system within a network of wound care centers. Arch Surg 2004 139; 251-258 5. Cullen B, Smith R, McMulloch E, Silcock D, and Morrison L: Mechanism of action of Promogran, a protease modulating matrix, for the treatment of diabetic foot ulcers.

Wound Rep Reg 2002; 10: 16-25.

6. Ford CN, Reinhard ER, Yeh D, Syrek D, De Las Morenas A, Bergmann SB, Williams S, and Hamori CA: Interim analysis of a prospective, randomised trial of vacuum assisted closure versus health point system in the management of pressure ulcers.

Ann Plast Surg 2002; 49: 55-61.

7. Griffiths RD, Fernandez RS, and Ussia CA: Is tap water a safe alternative to normal saline for wound irrigation in the community setting? J Wound Care 2001; 10: 407-411.

8. Ha Van G, Siney H, Hartmann-Heurtier A, Jacqueminet S, Greau F and Grimaldi A: Nonremovable, windowed, fibroglass cast boot in the treatment of diabetic plantar ulcers: Efficacy, safety, and compliance. Diabetes Care 2003; 26: 2848-2852.

9. Lafrati MD, Pare GJ, O’Donnel TF and Estes J: Is the nihilistic approach to surgical reduction of superficial and perforator vein incompetence for venous ulcer justified?, J Vasc Surg 2002; 36: 1167-1174.

10. Margolis DJ, Allen-Taylor L, Hofstad O and Berlin JA: Diabetic neuropathic foot ulcers: The association of wound size, wound duration and wound grade on healing.

Diabetes Care 2002; 25: 1835-1839.

11. Marston WA, Hanft J, Norwood P, and Pollak R: The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers., Diabetes Care 2003; 26: 1701-1705.

12. Moffatt CJ, McCullagh L, O’Connor T, Doherty DC, Hourican C, Stevens J, Mole T and Franks PJ: Randomized trial of four-layer and two-layer bandage system in the management of chronic venous ulceration. Wound Rep Reg 2003; 11: 166-171.

13. Mueller MJ, Sinacore DR, Hastings MK, Strube MJ and Johnson JE: Effect of Achilles tendon lengthening on neuropathic plantar ulcers. A randomized trial.

J Bone Joint Surg 2003; 85A: 1436-1445.

14. Paola LD, Faglia E, Caminiti M, Clerici G, Ninkovic S and Deanesi V: Ulcer recurrence following first ray amputation in diabetic patients., Diabetes Care 2003; 26: 1874-1878.

15. Peters EJ, Lavery LA, Armstrong DG, and Fleischli JG: Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial.

Arch Phys Med Rehabil 2001; 82: 721-725.

16. Scherer LA, Shiver S, Chang M, Meridith W, and Owings JT: The vacuum assisted closure device. A method of securing skin grafts and improving graft survival.

Arch Surg 2003; 137: 930-934.

17. Smith J: Debridement of diabetic foot ulcers. Cochrane-Database-Syst-Rev 2002; 4.

18. Tsang MW, Wong WKR, Hung CS, Lai KM, Tang W, Cheung EYN, Kam G, Leung L, Chan CW, Chu CM, and Lam EKH: Human Epidermal Growth Factor enhances healing of diabetic foot ulcers., Diabetes Care 2003; 26: 1856-1861.

19. Veves A, Sheehan P, and Pham HT: A randomised, controlled trial of Promogran (a collagen/oxidised regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg 2002; 137: 822-827.

20. Vin F, Teot L, and Meaume S: The healing properties of Promogran in venous leg ulcers. J Wound Care 2002, 11.

21. Zimny S, Schatz H and Pfohl U: The effects of applied felted foam on wound healing and healing times in the therapy of neuropathic diabetic foot ulcers., Diabet Med 2003; 20: 622-625.

EWMA JOURNAL

2005 VOL 5 NO 1

full speed ahead towards healing success

ÂŽ

Suprasorb C with Trimpact effect

The Collagen in SuprasorbÂŽ C provides a specific alteration of the wound environment -- in all three stages of wound healing.

I Exudation: Wound cleansing and efficient binding of excess proteases I Granulation: Stimulation and repair through increased collagen synthesis I Epithelialisation: Promotion of re-epithelialisation

Lohmann & Rauscher GmbH & Co. KG Postfach 23 43, D-56513 Neuwied / Germany Phone: ++49 26 34 / 99-0 Fax: ++49 26 34 / 99-64 67 E-Mail: info@de.LRmed.com www. lohmann-rauscher.com 32024/0103/e

Vascularized Bone Replacement for the Treatment of Chronic Bone Defects – Initial Results of Microsurgical Solid Matrix Vascularization This paper was first published in German in Zeitschrift für Wundheilung in 2004 vol 9;3: 102-108. It is reproduced here by kind permission of the Editor.

Ulrich Kneser and Andreas Arkudas, Elias Polykandriotis, Jan Ohnolz, Kristina Heidner, Alexander D. Bach, Jürgen Kopp, Raymund E. Horch Department of Plastic and Hand Surgery University of Erlangen Medical Center Erlangen, Germany Correspondence to: Univ.- Prof.

Dr. Raymund E. Horch Abteilung Plastische und Handchirurgie, Chirurgische Universitätsklinik, Universitätsklinikum Erlangen.

Krankenhausstrasse 12 DE-91054 Erlangen Germany Tel:+49-9131-85-33277 Fax:+49-9131-85-39327 raymund.horch@ chir.imed.uni-erlangen.de

Summary: In the clinical setting of severe infection, radiotherapy evoked soft tissue damage and aseptic bone necrosis, bone defects call for vascularized bone reconstruction. Nowadays, the therapeutic options for such defects are limited to the microsurgical “free” transfer of vascularized bone or bone lengthening procedures. However, both methods draw on grave donor morbidity with them. New technologies, such as tissue engineering are being developed aiming towards creation of bioartificial bone tissues. However, the initial vasculariziation of these “neo” tissues remains problematic. In this study a microsurgical concept for the vascularization of solid preformed matrices is established and evaluated in a rat model. In phase1 an arteriovenous anastomosis between femoral artery and vein is created. In phase 2 an arteriovenous loop is created using a venous graft.

In phase 3 the AV-loop is placed around a cylindrical simulation construct. The loop and construct are placed in an isolation chamber. The patency of the anastomosis was evaluated using India ink injection. In phase 1 and 2, a continuous improvement of patency rates was observed. In phase 3, 80% of AV loops in the isolation chamber were patent after 48 h. This study demonstrates for the first time the feasibility of the placement of an AV loop around a solid preformed construct in an isolation chamber model. It is an important step towards creation of a preformed, axial vascularized bioartificial bone tissue.

Keywords: Tissue engineering; axial vascularization; arteriovenous loop

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INTRODUCTION The reconstruction of extended tissue defects requires complex surgical approaches. In some cases only microsurgical tissue transfer (free flaps) can provide for adequate reconstruction. The surgeon my choose from a plethora of therapeutic options in terms of tissue availability (skin, fat, muscle, fascia, bone) and perfusion pattern (pedicled, free microsurgical).1-6 Currently used flaps enable, in most cases, satisfying functional and aesthetic reconstruction. However, large scale osseous or muscle flaps cause significant morbidity at the donor site with long-term pain and functional impairment. Furthermore, available vascularized bone grafts are limited in size, form and plasticity. As a consequence, the spectrum of indications for such procedures remains narrow. Flap prefabrication offers an alternative for creation of form-adapted tissue compounds but does not solve the problem of donor site morbidity.7-10 Therefore, new options are sought in the field of tissue engineering aiming towards the creation of de-novo custom-made bone tissues for reconstruction of bone defects.

The use of osteogenic cells for in vitro creation of bioartificial bone tissues is a well established experimental procedure. The osteogenic cells show physiologic gene expression in the biomatrices and produce bone-like extracellular matrix.11-13 As an initial approach, biocompatible matrices seeded with osteogenic cells and bone morphogenetic proteins (BMP) have been placed into small bone defects14-17 and have evoked sufficient osseous regeneration.18-21 However, the success of cell-containing scaffolds without BMP is limited by a significant initial cellular loss, since nutrition of the transplanted cells during the initial phase is only provided by diffusion until sufficient extrinsic vascularization has taken place.22, 23 Therefore efficient transplantation of such constructs could EWMA JOURNAL

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Figure 1: Clinical example of a large posttraumatic segmental bone defect treated with extended free muscle flaps and subsequent distraction osteogenesis.

Figure 1a: Bone defect preoperatively.

Figure 1c: X-ray after distraction osteogenesis.

only be performed in small animal models, using comparably small tissue volumes with a high surface-to-volume ratio.

These approaches may well offer an alternative to autologous cancellous bone grafting for small to medium-sized bone defects but might prove insufficient for large-scale reconstruction. In the clinical setting of trauma, osteomyelitis and radiation after cancer resection, serious issues of dimensionality and blood perfusion arise. Figure 1 shows a typical clinical example of such a large posttraumatic segmental bone defect, which was treated with extended free muscle flaps and subsequent distraction osteogenesis to reestablish the original length of the extremity. Implantation of non vascularized large constructs into these bone defects would be futile. The development of vascularized bioartificial tissue equivalents, which combine the benefit

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Figure 1b: Bone defect after free muscle flap during distraction osteogenesis.

Figure 1d: Bone defect after distraction osteogenesis to reestablish the original length of the extremity.

of the tissue engineering with those of the vascularized flaps, are therefore a subject of current research.

The aim of this study was to characterize a small animal model for the axial vascularization of solid preformed bioartificial bone grafts with defined dimensions by means of an arteriovenous loop in an isolation chamber. Erol described the arteriovenous loop model for the prefabrication of tissues as early as 1980. He demonstrated successful vascularization of skin without any implications on creation of three-dimensional hard tissues. Later, Morrison used the model to generate vascularized soft tissue.24, 25 In contrast, the aim of our current study is the creation of vascularized bone tissue, transferable into bone defects after seeding with osteogenic cells. In the presented article we describe the design of the matrix-isolation chamber-unit and we present the corresponding microsurgical concepts in the 䊳 rat model.

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Figure 3a: Drawing of the dimensions of the simulation construct.

Figure 2: AV loop placed in the isolation chamber made of Teflon.

In red illustrated is the arterial branch of the AV loop, in blue the venous branch of the AV loop.

METHODS The arteriovenous loop model An arteriovenous fistula was created in the rat between the femoral artery and vein using a venous graft. The AV loop was then placed in the isolation chamber, preventing ingrowth from surrounding tissues. The chamber is connected with the organism only via a small aperture containing the vascular pedicle. The AV loop is placed around the construct, which was encased inside the chamber (Fig. 2).

Development of the matrix geometry and the isolation chamber The architecture and geometry of the matrix and the isolation chamber were defined according to the requirements of a matrix with axial pattern blood perfusion for the creation of a vascularized bone replacement construct.

The design was based on the studies of Morrison et al.24, 25 The requirements for the matrix were an adequate size for evaluation of the created tissue as well as an appropriate geometry to guarantee a close contact between the matrix and the loop without disturbing the blood circulation. The maximal size of the chamber and the mobility of the femoral pedicle were studied in rat cadavers during the initial phase. In the same time, the design of the simulation construct and the isolation chamber were optimized. The isolation chamber was attuned according to the inner and outer dimensions of the matrix lying within so as to ensure a secure and easy insertion of the matrix and the pedicle and an adequate isolation of the structures inside the chamber from the surrounding tissues. The isolation chamber should be composed of heat resistant and biologically inert materials. Matters of logistics and mass-production for following studies were taken into account.

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Figure 3b: Drawing of the dimensions of the isolation chamber.

Production of the simulation constructs and the isolation chambers The simulation constructs for the initial evaluation were made of aluminium (Fig. 3) in the exact dimensions of the porous matrices to be used in the future. In the present study the chambers were made of medical grade Teflon.

Both the simulation prototype and the isolation chambers were made in piece production in the workshop of the Institute of Material Sciences, Department of Glass and Ceramics, University of Erlangen, and were cleaned and autoclaved before implantation.

Animals Male Lewis rats were used in all experiments (Charles River, Germany) with a weight range from 200 to 250 grams. The prefecture of Mittelfranken approved the study protocol. The experiments were performed in the laboratories of the Department of Surgery, University of Erlangen. All animals were housed under identical conditions and were given standard rat chow (TechLad) and water ad libitum. The animals were exposed to a continuous 12-hour light/dark cycle. They were narcotized for the surgical intervention with Isoflurane 1,5-2% (Baxter, Unterschleissheim). Perioperative the animals received a single injection of Cefotiam (Spizef, 50 mg/kg), Heparin (Liquemin, 80mg/kg) and Buprenorphin (Temgesic, 0,1mg/kg) subcutaneously.

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Figure 3c: The lid and the lower part of the isolation chamber and the simulation construct.

Study design The study was divided into three phases: In phase 1 an arteriovenous anastomosis between femoral artery and vein was created and the optimal surgical technique of the anastomosis was developed. In phase 2 a 15 mm venous graft from the contralateral femoral vein was interposed between the femoral artery and vein at the donor site.

Thereupon mobilisation of the graft and the adjustment of the anastomosis with different vessel calibre had been optimised. In phase 3 the AV loop was placed around the cylindrical simulation construct made of aluminium. The simulation construct was then placed together with the AV loop in the isolation chamber made of Teflon and fixed in the groin of the animals. A total of 23 animals had been used. In phase 1, seven animals were needed, in phase 2, eight and in phase 3, eight animals.

Surgical techniques The surgical procedures were performed under sterile conditions by a trained micro surgeon (E. Polykandriotis) under a Karl Zeiss operating microscope (magnification ⴒ25). A longitudinal incision was made extending from the left groin to the knee. Femoral vessels were exposed; the femoral nerve was separated and protected from damage. After that, the femoral artery and vein were mobilized from the epigastric artery to the bifurcation of the popliteal artery. Femoral artery and vein were separated, distally ligated and dissected. The lumina were then flushed with Heparin/saline solution (100 U/ml Heparin).

In phase 1, an arteriovenous anastomosis was sutured using Nylon 11-0 (Ethicon, Hamburg-Norderstedt) interrupted sutures. The anastomosis was observed for five minutes after releasing the clamps and then covered with a wet gauze for 30 minutes. After 30 minutes, patency of

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Figure 4: Surgical wound of animal 6 in phase 3.

The patency of the loop was checked 48 hours after implantation of the isolation chamber by India ink injection.

Both parts of the loop, the arterial and the venous part, were filled with India ink. This proved the patency of the AV loop.

Blue arrow = venous branch Red arrow = arterial branch K = simulation construct made of aluminium T = isolation chamber Magnification: ⴒ20

the anastomosis was rechecked using the smooth out test.

Animals were then killed by an overdose of anaesthetic and in addition by cervical dislocation. In phase 2, the contralateral femoral vein was mobilized and a venous graft was raised. The graft measured a total length of 15 mm before transection. The graft was then interposed in original blood flow direction between the femoral artery and vein with Nylon 11- 0 interrupted sutures. Control for patency took place as described in phase 1. In phase 3, after 30 minutes the patent AV loop was placed around the sterilized simulation construct. The AV loop and the construct were then placed in the sterile isolation chamber.

After the patency of the AV loop had been checked, the lid was fixed on the isolation chamber with two Prolene 7-0 sutures. The chamber was fixed with two Vicryl 5-0 sutures at the fascia of the adductor muscles. After 30 minutes, patency of the blood vessels was checked again.

Then the situs was closed using running sutures. After 3 and 48 hours the chamber was exposed, the lid removed and the simulation construct as well as the AV loop examined. Using the smooth out test, the patency of the blood vessels was checked. Furthermore India ink (50% v/v India ink - Rohrer) in 5% gelatine (Roth, Karlsruhe) and 4% mannitol (Neolab, Heidelberg) was injected into the abdominal aorta to demonstrate patency of the loop.

The filling of the venous part was observed and photo documented. After that, the construct was taken out of the isolation chamber and the anastomosis was inspected 䊳 under the operating microscope.

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Table 1: Patency of the anastomosis in phase 1

Table 2: Patency of the AV loop in phase 2

Animal Nr.

1

2

3

4

5

6

7

Animal Nr.

1

2

3

4

5

6

7

8

Patency of the anastomosis in phase 1 (after 30 min)

-

-

+

+

-

+

+

Patency of the AV loop in phase 2 (after 30 min)

-

-

+

+

-

+

+

+

RESULTS Matrix geometry and isolation chamber First, the maximal outer dimensions of the isolation chamber were defined in cadaver studies. The chamber with a basis plate for fixation at the fascia of the subjacent muscles seemed to be appropriate for the following studies. The round design allows the individual item production in larger series by a CNC-controlled lathe. The outer diameter of the chamber is 14 mm; the inner dimensions are 10ⴒ6 mm. The height of the lid is 4 mm. The opening of the chamber is bounded by the lid and the lower part of the chamber and measures 6ⴒ4 mm. The isolation chamber has perforations for fixation at the base and securing the lid (Fig. 3 b,c). The dimensions of the construct were simulated for the initial experiments in a series of constructs made of aluminium. Thereby an AV loop lying in a channel showed the best contact between the vessels and the construct. The height of the groove is 1.5 mm, the dimensions of the constructs are 9ⴒ5 mm. The groove is lying 2.5 mm under the surface of the construct (Fig. 3 a). The dimensions of the construct and the chamber were chosen to ensure a minimum of dead space left in the chamber. The described construct-chamber-configuration was checked in phase 3 of the studies.

Animals The surgical procedure was well tolerated by all animals.

After ligation of the femoral artery the limbs were still well perfused. There was no significant intra-operative blood loss.

Phase 1 In phase 1 there was a noticeable learning-curve regarding the performance of the anastomosis. Although all anastomoses were initially patent, the animals 1 and 2 showed an interruption of the blood flow within the first 30 minutes. The atraumatic preparation of the vessels and the avoidance of endothelial lesions seem to be very important (Tab. 1).

Phase 2 As described in phase 1, there was a learning curve for the creation of the AV loop. The atraumatic preparation of the venous graft seems to be of particular importance.

The suture of the veno-venous anastomsis of animals 1 and 2 caused problems, so that the venous part of the AV loop showed no outflow after opening of the anastomo14

sis. The venous graft of animal 5 had a marginal trauma by mobilization. After initial patency of the anastomosis the blood flow was disrupted within the first 30 minutes (Tab. 2).

Phase 3 All AV loops were patent after 30 minutes. No animal had infection signs or haematomas at the time of revision. The loops of animals 1-3 were controlled after three hours.

Animal 1 showed pedicle kinking due to wrong placement, so that the blood flow was interrupted. The risk of kinking of the pedicle rises with increasing length. The mobility of the chamber fixed at the fascia of the muscle showed to be problematic by movement of the lower limb. Animal 7 had a coagulated vessel near the venous graft. Maybe the heat damage caused a secondary thrombosis of the graft.

After 48 hours the loops appeared embedded in the channel of the construct in a fibrin clot and no kinking of the pedicle occurred within the isolation chamber (Tab. 3).

The patency of the loop was checked after three and 48 hours by macroscopic investigation and India ink injection. The results of the macroscopic investigation were similar to the India ink injection. Referring to India ink injection, a loop was defined as patent, when both parts of the loop, the arterial and the venous part, were filled with India ink (Fig. 4).

DISCUSSION This study demonstrates for the first time the feasibility of the placement of an AV loop around a solid preformed construct in an isolation chamber with defined outer dimensions. The continuous improvement of anastomosis patency in phase 1 and 2 underlines the complexity of this operation and suggests that the operation should be performed only by a trained microsurgeon. To avoid variability of the results of a study, it seems important that the Table 3: Patency of the AV loop in the isolation chamber in phase 3 Animal Nr.

1

2

3

4

5

6

7

8

Patency of the AV loop in the isolation chamber in phase 3 (after 30 min)

+

+

+

+

+

+

+

+

(after 3h)

-

+

+ +

+

+

-

+

(after 48h)

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same surgeon performs the anastomosis and the implantation of the constructs through the whole study.

In phase 3 the importance of positioning of the loop in the isolation chamber as well as positioning of the chamber in the groin for the patency of the loop became evident.

The placement of the fragile AV loop requires full attention. The mobility of the limb also has to be considered to avoid tension or kinking of the pedicle. The geometry and dimensions of the isolation chamber are suitable for the AV loop model. The design of the simulation construct guarantees good guidance of the loop without constriction or kinking.

The model of arteriovenous loops using the femoral artery and vein in the rat is well established. After ligation of the femoral vessels, the lower limb is sufficiently perfused by collateral vessels. There are no cardiac or circulatory problems caused by the shunt volume of the loop. In a clinical situation the femoral vessel axis wouldn’t be used because of various problems. In these cases the creation of a new vessel axis by a long venous graft is recommended because thereby the existing vessel axis can remain. For example a great saphenous vein graft between the popliteal artery and vein for creation of a vascularized bone constructs is conceivable in the case of bone defects of the lower leg.

Outlook In future studies porous solid matrices of processed cancellous bone (Tutobone) with the same dimensions as the simulation construct of this study will be used. First, the vascularization kinetics of the matrices will be quantified.

In following studies, osteogenic cells will be injected into the vascularized matrix to create axially vascularized bioartificial bone equivalent. Such a bone construct can be placed into a bone defect as a pedicled or microsurgically transferable free flap. Beside the creation of vascularized bone replacement tissue there will be the possibility of prefabrication of bioartificial tissues consisting of different kinds of tissues such as bone, skin or muscle.

CONCLUSION This study determines for the first time elementary microsurgical and experimental aspects of the placement of an AV loop around a solid preformed construct in an isolation chamber. The placement of an AV loop around a solid preformed construct is feasible and has a small rate of vessel complications. In future studies porous solid matrices of processed cancellous bone (Tutobone) will be vascularized in the isolation chamber and will be colonized with osteogenic cells after vascularization has taken place. The results of this study constitute therefore an important step towards creation of axial vascularized preformed bioartificial bone tissue for treatment of 䡵 extended bone defects.

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Acknowledgements This study was supported by the Dr. Robert Pfleger foundation (Bamberg). The authors would like to thank Peter Reinhardt from the workshop of the Institute of Material Sciences, University of Erlangen, for production of the isolation chambers and the aluminium simulation constructs and the director of the Institute of Material Sciences, Department of Glass and Ceramics, Prof. Greil, for his kind support.

References 1. Daniel RK and Taylor GI: Distant transfer of an island flap by microvascular anastomoses. A clinical technique. Plast Reconstr Surg 1973; 52: 111-7.

2. Gilbert A and Teot L: The free scapular flap. Plast Reconstr Surg 1982; 69: 601-4.

3. Nakatsuka T, Harii K, Asato H, Takushima A, Ebihara S, Kimata Y, Yamada A, Ueda K and Ichioka S: Analytic review of 2372 free flap transfers for head and neck reconstruction following cancer resection. J Reconstr Microsurg 2003; 19: 363-8; discussion 369.

4. Nakatsuka T, Harii K, Yamada A, Asato H and Ebihara S: Versatility of a free inferior rectus abdominis flap for head and neck reconstruction: analysis of 200 cases. Plast Reconstr Surg 1994; 93: 762-9.

5. Nassif TM, Vidal L, Bovet JL and Baudet J: The parascapular flap: a new cutaneous microsurgical free flap. Plast Reconstr Surg 1982; 69: 591-600.

6. Olivari N: The latissimus flap. Br J Plast Surg 1976; 29: 126-8.

7. Khouri RK, Upton J and Shaw WW: Prefabrication of composite free flaps through staged microvascular transfer: an experimental and clinical study.

Plast Reconstr Surg 1991; 87: 108-15.

8. Khouri RK, Upton J and Shaw WW: Principles of flap prefabrication.

Clin Plast Surg 1992; 19: 763-71.

9. Pribaz JJ, Fine N and Orgill DP: Flap prefabrication in the head and neck: a 10-year experience. Plast Reconstr Surg 1999; 103: 808-20.

10. Schipper J, Ridder GJ, Maier W and Horch RE: [The preconditioning and prelamination of pedicled and free microvascular anastomised flaps with the technique of vacuum assisted closure]. Laryngorhinootologie 2003; 82: 421-7.

11. Schaefer DJ, Munder B, Voigt M and Stark GB: Proliferation of human osteoblastic cells and synthesis of extracellular bone matrix on biomaterials.

Mat.Res.Soc.Symp.Proc. 1998; 530: 105-109.

12. Yoshikawa T, Ohgushi H, Nakajima H, Yamada E, Ichijima K, Tamai S and Ohta T: In vivo osteogenic durability of cultured bone in porous ceramics: a novel method for autogenous bone graft substitution. Transplantation 2000; 69: 128-34.

13. Arnold U, Lindenhayn K and Perka C: In vitro-cultivation of human periosteum derived cells in bioresorbable polymer-TCP-composites. Biomaterials 2002; 23: 2303-10.

14. Bruder SP and Fox BS: Tissue engineering of bone. Cell based strategies.

Clin.Orthop. 1999; S68-S83.

15. Kneser U, Schaefer DJ, Munder B, Klemt C, Andree C and Stark GB: Tissue Engineering of Bone. Min Invas Sur & Allied Technol 2002; 11: 107-116.

16. Vacanti CA and Bonassar LJ: An overview of tissue engineered bone.

Clin.Orthop. 1999; S375-S381.

17. Vacanti CA, Bonassar LJ, Vacanti MP and Shufflebarger J: Replacement of an avulsed phalanx with tissue-engineered bone.

N.Engl.J.Med. 2001; 344: 1511-1514.

18. Kon E, Muraglia A, Corsi A, Bianco P, Marcacci M, Martin I, Boyde A, Ruspantini I, Chistolini P, Rocca M, Giardino R, Cancedda R and Quarto R: Autologous bone marrow stromal cells loaded onto porous hydroxyapatite ceramic accelerate bone repair in critical-size defects of sheep long bones. J Biomed Mater Res 2000; 49: 328-37.

19. Krebsbach PH, Mankani MH, Satomura K, Kuznetsov SA and Robey PG: Repair of craniotomy defects using bone marrow stromal cells. Transplantation 1998; 66: 1272-1278.

20. Perka C, Schultz O, Spitzer RS, Lindenhayn K, Burmester GR and Sittinger M: Segmental bone repair by tissue-engineered periosteal cell transplants with bioresorbable fleece and fibrin scaffolds in rabbits. Biomaterials 2000; 21: 1145-1153.

21. Winn SR, Schmitt JM, Buck D, Hu Y, Grainger D and Hollinger JO: Tissue-engineered bone biomimetic to regenerate calvarial criticalsized defects in athymic rats.

Biomed.Mater.Res. 1999; 45: 414-421.

22. Cassell OC, Hofer SO, Morrison WA and Knight KR: Vascularisation of tissue-engineered grafts: the regulation of angiogenesis in reconstructive surgery and in disease states. Br J Plast Surg 2002; 55: 603-10.

23. Kneser U, Kaufmann PM, Fiegel HC, Pollok JM, Kluth D, Herbst H and Rogiers X: Longterm differentiated function of heterotopically transplanted hepatocytes on three-dimensional polymer matrices. J.Biomed.Mater.Res. 1999; 47: 494-503.

24. Hofer SO, Knight KM, Cooper-White JJ, O’Connor AJ, Perera JM, Romeo-Meeuw R, Penington AJ, Knight KR, Morrison WA and Messina A: Increasing the volume of vascularized tissue formation in engineered constructs: an experimental study in rats.

Plast Reconstr Surg 2003; 111: 1186-92; discussion 1193-4.

25. Tanaka Y, Sung KC, Tsutsumi A, Ohba S, Ueda K and Morrison WA: Tissue engineering skin flaps: which vascular carrier, arteriovenous shunt loop or arteriovenous bundle, has more potential for angiogenesis and tissue generation?

Plast Reconstr Surg 2003; 112: 1636-44.

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The Importance of Family and Domiciliary Treatment of Immobile Patients with Chronic Wounds

F. Petrella, MD and G. Nebbioso A.Gallucci G. Corona A. Colin S. Fiocco S. Notarangelo G. Maio Italy

Summary: This study was conducted by a team of doctors and nurses, on a sample of selected immobile patients. The aim of the survey was to evaluate the impact that the immobile patient has on his family, the level of transmission of information between doctor and patient, the analysis of social economic context, new therapeutic strategies in the treatment of immobilised patients.

When the domiciliary assistance services began to take care of an immobile patient, the family received a questionnaire with 23 questions. The study began in May 2003 and ended in September 2003, 481 patients were examined. The analysis of data shows that: 䡲 The family does not know how to treat immobile patients, even though, in most cases, the family represents the place where the immobile patient is treated. 䡲 The family does not have a good knowledge of prevention strategies and about the quality and the quantity of patient’s diet, they do not make use of new dressings for pressure ulcers treatment.

INTRODUCTION Most patients who require domiciliary treatments are elderly people affected by a variety of diseases.

In the course of their clinical history they usually have consulted a number of doctors and specialists. However, the person who usually looks after this kind of patient at home often lacks the specific expertise required and their treatments are based on empirical evidence or, worse, on popular traditions.

The lack of knowledge of the care giver and the patient’s family can be a consequence of doctors, nurses and health professionals being unable to give the necessary information to ensure the correct care of the patient, for example, to prevent pressure ulcers and for an appropriate diet. For the effective dissemination of information, it is essential to consider the patient and his family’s

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cultural and socio-economic status, the amount of time that the family can dedicate to care provision and the age of the home care nurse who cares for him/her (in the last few years there has often been a lack of continuity of nursing care, so there is a difficulty in passing on information).

Our study was based on a sample of patients selected by a group of physicians and nurses working in public health centres situated in five regions in southern Italy – Campania, Puglia, Basilicata, Calabria, Sicilia. All of them have visited their patients in their own homes. All the patients that were included in the evaluation suffered from chronic wounds and required domiciliary treatment.

AIM The aim of the study was to evaluate the requirements of this group of patients taking into consideration: 䡲 Place of residence 䡲 Treatment 䡲 Incidence and the prevention of the pressure ulcers 䡲 Diet 䡲 Time dedicated to the patient 䡲 Social services offered by public welfare 䡲 The family economic and social conditions MATERIAL AND METHODS All subjects (patients or their families) were evaluated using a simple questionnaire composed by 23 questions with simple “yes/no” answers and numbers 1,2,3. The selected patients lived in: Naples and its southern provinces; Benevento and its provinces; Foggia; Crotone; Melfi and Catania and its southern provinces.

The questionnaire was divided into three parts: Part A (Table 1) had questions relating to pressure ulcers, Part B (Table 2) had questions about diet and Part C (Table 3) evaluated socioeconomic status.

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Table 1: Questions relating to pressure ulcers Are you immobilized?

Have you got any wounds on your skin?

Have you got any pressure ulcers?

Have you any other chronic wounds?

Do you make use of pressure ulcer prevention methods?

Do you make use of modern dressings?

Are you able to take care of you by yourself?

Are you receiving enteric nutrition?

Are you having parenteral nutrition?

RESULTS The study began in May 2003 and ended in September 2004. 481 patients were examined and their details can be seen in Table 4.

Table 4: Age and gender of patients Total patients

481

Female Average age

301 (63%) 77.6 (53 -94)

Male Average age

180 (37%) 75.8 (52- 88)

Do you live with your family?

Does your nurse live with you?

Is your nurse non EU? Are you able to chew food?

Table 2: Questions about diet Do you cook your food at home?

Does the cook stay at home?

Has he/she enough time to cook?

How many times in a day do you eat?

How many times in a week do you eat pasta?

How many times in a week do you eat meat or fish?

How long does it take to eat?

Do you measure the amount of water you drink in a day?

Do you follow a specific diet?

Do you usually drink sweetened drinks between your meals?

In total, 343 patients (71%) were permanently immobile; 486 patients (84%) had cutaneous wounds; 363 patients (89%) had pressure ulcers and 94 patients (23%) had chronic wounds. 227 bed-fast patients (47%) used pressure-relieving devices and only 181 patients were treated with modern dressings. This data is shown in more detail in Table 5.

Table 5: Answers to the questions relating to pressure ulcers Yes

No

Are you permanently immobilised?

343 (71%)

138 (29%)

Have you got any cutaneous wounds?

406 (84%)

75 (16%)

Have you got any pressure ulcers?

363 (89%)

43 (11%)

94 (23%)

312 (77%)

Have you any other chronic wounds?

Do you make use of pressure ulcer prevention strategies?

227 (47%)

254 (53%)

Do you use additional nutrition?

Do you eat liquidised food?

Do you make use of modern dressings?

181 (38%)

300 (62%)

If yes, how many times a week?

Did anyone inform you about your caloric requirements?

If yes, who did that?

Table 3: Questions relating socio-economic status Do you live on your own pension?

Do you have any other means?

Do you have a civil disability pension?

Are these means enough?

Does your family help you?

Does the patient live in poor, non-hygienic or unhealthy conditions? (in the interviewer’s opinion) Are the social services present to improve his/her conditions?

If, yes, what kind of measures did they take?

It was important for the interviewer to be very clear in asking the questions and explaining their meaning to the patient or to his/her family. It was also essential for the interviewer to distinguish between pressure ulcers and other chronic wounds.

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Out of the 431 (90%) patients who were not self-sufficient, 409 patients (85%) lived with their family, 437 (91%) patients lived with the person who physically took care of them, and in 146 (30%) cases the patients were nursed by non EU care givers all day.

Among the patients having enteral nutrition, 25 (5%), there were 17 (4%) patients having parenteral nutrition and 399 (83%) patients who could chew and a further 34 (8%) could only swallow. For all the patients (except for those receiving enteral and parenteral nutrition) their food was cooked at home (including nursing homes for elderly people). In 85% of the cases the person who cooked for the patient was always at home and 89% asserted that they had sufficient time to do that. The time spent feeding the patient varied from 30 minutes for 38% to an hour for 45% and it was an hour and half for 17%. In 99.6% of cases the patient ate twice or three times a day. The types 䊳 of food are summarised in Table 6.

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Table 6: Results for dietary questions How many times in a day do you eat?

1

2 (0.4%) 2

How many times in a week do you eat pasta?

2

29 (6%)

How many times in a week do you eat meat or fish?

Never 22 (5%) <2

The remaining results can be seen in Table 7 Table 7: Dietary intake Yes

No

Do you measure the litres of water you drink in a day?

152 (32%)

329 (68%)

Do you follow a specific diet?

81 (17%)

400 (73%)

Do you make use of additional nutrition?

124 (26%)

357 (74%)

Do you usually drink sweetened drinks between your meals?

193 (40%)

288 (60%)

Do you eat liquidised food?

187 (39%)

294 (61%)

If yes, how many times in a week?

2 times 27 (14%) 4 times 85 (46%) 6 times 75 (40%)

Did anyone inform you about your caloric requirements?

126 (26%)

355 (74%)

doctor

126 (100%)

If yes, who did that?

A total of 311 (81%) patients lived on a pension and 311 also had a civil disability pension. Only 115 (24%) of patients declared that they had additional means, while 48% declared that their income was sufficient. For 287 patients their income was subsidised by the family. At least 72 patients lived in poor, non-hygienic and unhealthy conditions and in poor socio-economic conditions in the opinion of the interviewer. Sixty-one patients received public welfare.

SEPARATION OF DATA AND ANALYSIS OF THE RESULTS Following the analysis of the results, a close relationship emerged between immobility, lack of self-sufficiency and chronic wounds as shown in Table 8.

Table 8: Clinical characteristics of the patients Not self-sufficient

90%

Immobile

71%

Chronic wounds

84%

The study found out that 89% of patients suffered from pressure ulcers. The remaining 11% were affected by other kinds of chronic wounds. It is important to point out that 12% of patients presented with both pressure ulcers and other chronic wounds. This meant that the patient often required visits from a domiciliary nursing service from the social service of the local health centre.

There is little focus on pressure ulcer prevention. Indeed if we compare the data of immobile patients with 18

4

157 (32.6%)

3

322 (67%)

161 (33%)

6

291 (61%)

130 (27%)

>3

329 (68%)

that of patients who already used pressure ulcer prevention equipment before intervention from a healthcare professional, we note a remarkable difference as 71% of the patients were immobile but only 47% had pressure ulcer prevention equipment. However, if we separate the data and we compare general data with that of patients registered in Asl Venosa 1 (Melfi), Basilicata and those registered in Crotone (Calabria), we note that in these areas there was a greater use of pressure ulcer prevention equipment. In these two districts 84% and 82% of patients respectively had prevention equipment compared with the overall 47%. The reasons for this differed between the two regions.

In the Basilicata area it is possible to reuse pressure ulcer prevention equipment; thus making them more immediately available to a greater number of patients and, in addition, focusing attention on the importance of pressure ulcer prevention. In Calabria the positive results are the result of very thorough care practices operated by both local health organisations and hospital healthcare professionals to ensure that good and appropriate care is taken of non-self-sufficient patients, the elderly, oncologic and neurological patients. The success of these practices underlines the need for health professionals everywhere to recognise that both hospital and territorial health centres have to work together to achieve quality care.

However we must point out that the prescription of pressure ulcer prevention devices does not necessarily reduce their incidence as shown in Table 9.

Table 9: Pressure ulcer incidence and use pressure ulcer prevention equipment in different regions Pressure ulcer incidence

Use pressure ulcer prevention equipment

100%

84%

Calabria

89%

82%

Campania

76%

46%

Puglia

81%

51%

Sicilia

100%

20%

Basilicata

This data underline the fact that the most frequently used method for pressure ulcer prevention in immobile patients (alternating pressure air mattress) cannot, by itself, prevent the occurrence of pressure ulcers. However, as we did not have a record of the date of pressure ulcer development and the equipment used prior to pressure ulcer treatment, 䊳 this finding must be treated with caution.

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In a high percentage of patients, the chronic wounds were treated with a traditional dressing (gauze, metallic silver, etc.); only in 38% had modern dressings been used.

Scientific evidence shows the superiority of this kind of modern product and their limited use is a direct consequence of the low priority given to pressure ulcer prevention and treatment and the subsequent lack of practical experience of the health professionals who treat these ulcers every day. The general data do not totally explain the differences between local and regional situations. A higher percentage of use has been found in some places (Calabria – 71% and Basilicata – 61%). This data can be explained taking into account that these areas consist of small communities where it is easier to run and support formative training for health care professionals, However, the data does not emphasise one of the major benefits in the treatment of pressure ulcers in those geographic areas – the patient’s family. In many cases, the family plays the most important role in the treatment of this kind of patient; the family takes care of him/her. The study showed that 89% of patients lived with their families and in 85% of cases the person providing nursing care was always there. In 30% of cases a nurse performs this function. These data are not universal, in the big cities we find a higher percentage of foreign nurses. In the metropolitan area of Naples the percentage is 39%, whereas in Crotone it is 27% and in the province of Catania it is only 20%.

In agricultural areas, such as the province of Benevento, this figure reduces to 3%.

A foreign nurse can cause problems with communication, if there is a lack of understanding between the nurse and the health team. Such problems become more serious if communication with the family is also taken into consideration. There is a “triangle” of communication linking the health team, the family and the attendant. The possibility of misunderstandings occurring about both the therapy (information from the physician to the attendant) and the communication of possible changes in the clinical state (information from the attendant to the physician) is high.

These potential communication problems can have serious repercussions on the validity of the treatments.

Another serious problem (illustrated by the analysis of the data of this study) is the poor knowledge of the patient’s nutritional state and his/her requirements. In 74% of the cases, the family has no information about the immobile patient’s protein and caloric requirements, and, above all if he/she has pressure ulcers. In addition, 73% of the patients do not follow specific dietetic plans.

However, the small number of patients, who do have this information, were diabetics and, as a consequence, are already following a specific diet. Their diet, therefore, represents only a part of metabolic disease treatment and it is not part of the information included in a therapeutic 20

plan aiming to prevent complications caused by under nourishment.

In 94% of cases the main food is pasta and they eat pasta four to six times in a week. While 68% eat meat or fish more than three times in a week, some 5% of patients never eat meat or fish at all. When considered in a general way this would not seem negative, but if we consider them in relation to the lack of a dietetic plan and to the lack of knowledge of patients’ caloric-protein requirements, they acquire a negative meaning. What is shown is the complete inadequacy of many caregivers when required to establish the nutritional requirements of such patients and consequently to help them adapt their own dietary habits in both a qualitative and quantitative sense.

This has some consequences: 䡲 Nutrition is considered in a numeric way (breakfast, lunch and dinner = 3 meals) and the quantitative, qualitative and nutritional sides of it are not considered. More and more often the physicians intervene with noticeably under-nourished patients even if the relatives assert that they eat. 䡲 The care givers do not have sufficient knowledge of dietary requirements and so do not use additional nutrition, such as caloric- protein integrative. Only 26% of patients have used supplementary integrative food. 䡲 39% of the patients eat liquidised food as an alternative meal and in inadequate amounts. 䡲 32% of the patients know how much water they drink in a day. This does not permit an efficient and accurate water and electrolyte balance to be maintained. This goal could be easily attained through the catheterization of immobile patients with pressure ulcers, during all their treatment. 䡲 Only the 40% of patients drink sweetened drinks between the meal times. This could be used to give them an additional source of calories, for example, fruit juices included in an adequate dietetic plan.

Most families bear the cost of the health care for their own immobile family members. In fact, in 287 (60%) of the cases this support includes care provided by the nuclear family. In 48% of cases the patients thought their own income was sufficient. This is usually when in the same patient’s family there are pensions, civil invalidity subsidy, other yield sources, together with economic and material family support, so it is not necessary to seek the help of a nurse. However, if we separate the data, we note how the economic difficulties increase in the geographic areas where the family is not as supportive and the patients need care from nurses. This causes an enormous increase of expenses in order to provide this support. For example, EWMA JOURNAL

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in the metropolitan area of Naples only 37% of patients think their income is sufficient. However, only 44% of patients are helped by their family compared with the overall figure of 60%, and 39% of families need assistance from nurses compared with 30% total data. These data suggest that patients’ income is only usually enough when there is the added support of the family in both economic and material terms.

Most patients do not have sufficient means. In addition, we have to consider the 72 (15%) patients who, in the interviewers’ opinion, were living in poor, non-hygienic and unhealthy conditions. Their loneliness makes their condition worse and makes them more fragile. It is in these cases that the social services have had to intervene, but the help has been partial and insufficient. Unfortunately, 11 patients of this group did not have any help from social services at all.

CONCLUSIONS In most cases, both the economic burden and the provision of nursing care for immobile patients is carried by their families. The high incidence of pressure ulcers is increasing the load of work and the difficulties when treating the patient at home. Family carers do not have the specific knowledge and experience to treat this kind of patient and cope with their problems. They do not have the appropriate knowledge either in the field of prevention or in the quality and amount of nutrition required.

Most health centres are opening domiciliary nursing services. The problem is to provide adequate services to meet their institutional task. It is necessary to improve the assistance, to make it effective and to involve the several levels of assistance available: domiciliary, territorial and hospital.

Domiciliary integrated assistance and Domiciliary Hospital Assistance are surely an adequate answer, but they cannot be sufficient to cope with such a big problem, especially because the domiciliary presence often only occurs when the patient is in the acute phase of his chronic illness.

This study shows that many caregivers lack information and the necessity for health and social professionals to have appropriate knowledge in order to treat the patient in his own home and to inform and educate his family.

It is necessary to stipulate cooperation protocols between Local Health Centres and care givers in the provision of care to immobilized patients. The presence of home carers is still very limited. The burden of immobile patients with pressure ulcers cannot be completely left only in their family’s hands. Especially in the current climate where the typology of family is changing and there are not the extended family members available to care for immobile 䡵 relatives.

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Stuttgart 2005 FROM THE LABORATORY TO THE PATIENT: FUTURE ORGANISATION AND CARE OF PROBLEM WOUNDS STUTTGART · GERMANY · SEPTEMBER 15 -17 · 2005

PLEASE NOTE that the deadline for submitting abstracts for Stuttgart 2005 is 31 May Abstracts should be submitted on-line at www.stuttgart2005.org You may submit the abstract in either English, German or both in English and German.

If you are not able to submit your abstract on-line you can obtain a paper version abstract form from the Scientific Secretariat.

Scientific Secretariat Jutta Schnabel University Hospital Tübingen Waldhoernle Strasse 22 D -72072 Tübingen, Germany Tel: +49 (0) 7071 298 0336 scientific@stuttgart2005.org

www.stuttgart2005.org ETRS

21

After TIME: wound bed preparation for pressure ulcers CONTENTS Keywords: Pressure ulcers; wound bed preparation; chronic wounds; non-healing wounds; TIME framework; care of the elderly; advanced therapeutic products.

Marco Romanelli MD PhD Consultant dermatologist Department of Dermatology University of Pisa, Italy m.romanelli@ med.unipi.it

Madeleine Flanagan MSc, BSC (HONS), DIP, RGN Principal lecturer in tissue viability School of Continuing Professional Development Faculty of Health & Human Sciences University of Hertfordshire, Hatfield, UK m.flanagan@herts.ac.uk

Key points: 1. The treatment of pressure ulcers, particularly chronic or non-healing ulcers, places a significant burden on healthcare systems around the world.

Pressure ulcers can also have a serious detrimental effect on quality of life, particularly among older people.

2. The concept of wound bed preparation and the TIME framework provide a rational and systematic approach to both the assessment and treatment of pressure ulcers.

3. A number of technological developments have greatly enhanced both local and systemic treatments for pressure ulcers.

ABSTRACT Wound bed preparation is a relatively recent concept that can provide a structured approach to the management of chronic wounds.1 Its strength is that it provides a rational and systematic approach to both assessment and treatment that is particularly useful when managing non-healing pressure ulcers. This article reviews wound bed preparation and the latest developments in the treatment of pressure ulcers in the context of the TIME framework (Tissue management, Inflammation and infection control, Moisture balance and Epithelial (edge) advancement).1 INTRODUCTION Pressure ulcers are a serious health issue: they cause great pain and suffering to patients and place a significant financial burden on healthcare systems.

A recent European Pressure Ulcer Advisory Panel (EPUAP) study found that the overall prevalence of pressure ulcers in Europe was 18%, depending on patient group and care environment.2 It is likely that with an ageing population and increasing longevity the number of patients with

22

pressure ulcers or at risk of developing them will continue to rise in the future, placing greater strain on limited healthcare resources.3 Preventive measures are essential to reduce prevalence rates, so healthcare professionals must be able to identify and adopt appropriate strategies to meet individual patient requirements.

The past decade has seen the development of a number of new therapeutic options for the management of pressure ulcers. The introduction of advanced medical devices and new approaches to systemic treatment have led to greater understanding of the mechanism of tissue repair in pressure ulcers, and standardised guidelines for prevention and treatment have been published. The aim of this paper is to apply the components of wound bed preparation and the TIME framework (Tissue management, Inflammation and infection control, Moisture balance and Epithelial (edge) advancement)1 to the practical management of pressure ulcers. This framework will be used to describe the latest technological developments in local and systemic treatments for pressure ulcers.

It is assumed that adequate pressure relief will also be provided in all settings.

BEFORE TIME Pressure ulcers have been defined as ‘an area of localised damage to the skin and underlying tissue caused by pressure, shear, friction and/or a combination of these’.3 Although the term ‘pressure ulcer’ is the most widely accepted because it accurately describes the nature of this type of lesion, alternative terms such as ‘bedsores’, ‘decubitus’ and ‘pressure sores’ have also been used.

The intensity and duration of pressure is a critical factor in the development of pressure ulcers, as is the skin’s tolerance to pressure and its supporting structures. Pressure ulcers are traditionally graded according to the type and extent of tissue damage incurred. A variety of different grading models are available but there is some debate on which of these is the most accurate.

For the purpose of this paper the EPUAP pressure ulcer classification system3 is used (see Table 1).

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Scientific Article Table 1: EPUAP pressure ulcer classification system3 Grade

Definition

Grade 1 non-blanchable erythema of intact skin.

Discolouration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly on individuals with darker skin.

Grade 2 partial-thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister.

Grade 3 full-thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia.

Grade 4 Extensive destruction, tissue necrosis or damage to muscle, bone or supporting structures, with or without full-thickness skin loss.

The first crucial step in the management of pressure ulcers is a holistic assessment of the patient, paying particular attention to any underlying pathologies. The effective management of patients with pressure ulcers or at risk of developing them is an interdisciplinary concern that must be reflected in a united approach that involves both patients and informal carers. Such an approach depends on organisational support, adequate resourcing and the implementation of best clinical practice, which should address all of the following issues: – the redistribution of pressure – nutritional assessment – continence management – pain control.

Nutrition plays a fundamental role in the prevention and treatment of pressure ulcers, so a well-balanced, nutritionally adequate diet should be a priority for all patients with pressure ulcers or at risk of developing them. Anaemia reduces the amount of oxygen available to the fibroblasts, inhibiting the synthesis of collagen and, therefore, the healing process. Low levels of serum albumin and hypoproteinaemia can result in oedema, which reduces cutaneous elasticity, as well as important changes in the microcirculation and a consequent delay in wound closure.4 A series of European clinical guidelines have been formulated to define best practice in the prevention and treatment of pressure ulcers.3,5,6

TISSUE MANAGEMENT The removal of devitalised tissue from pressure ulcers is essential to prevent contamination, reduce tissue degradation and promote the development of healthy granulation tissue. Debridement also decreases bacterial burden and enhances visual assessment, which can improve accuracy when grading pressure ulcers.

Pressure ulcers with full-thickness skin loss (grades 3 and 4) are most commonly associated with extensive tissue damage and necrosis. Devitalised tissue can present as EWMA JOURNAL

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either thick, moist, offensive slough or dry, hard eschar.

Several factors must be considered when deciding on the most appropriate method of debridement in patients with pressure ulcers. These include the grade, size and location of the wound; the patient’s general condition; periwound moisture levels and pain management. Eschar in pressure ulcers need not be debrided if oedema, erythema, fluctuance or drainage are not present.3 Two processes are commonly used to remove devitalised tissue and decrease the cellular burden of pressure ulcers: selective and non-selective debridement. Selective debridement is a more natural process than non-selective debridement because it uses the body’s own enzymes, often in conjunction with exogenous enzymes, to remove only devitalised tissue. For this reason it is also usually less painful than non-selective debridement. In clinical practice a number of different debridement techniques may be used in the course of treating a large, necrotic pressure ulcer.

Selective debridement: this includes the following techniques: 䡲 Autolytic debridement is a natural process that can be promoted through the use of hydrocolloid, hydrogel or calcium alginate dressings. These create a moist wound interface that enhances the activity of endogenous proteolytic enzymes within the wound, liquefying and separating necrotic tissue from healthy tissue.7 This technique is particularly useful if, for technical or medical reasons, more invasive procedures are not suitable. 䡲 Enzymatic debridement is recommended for pressure ulcers covered by a dry, hard eschar, typically heel or sacral ulcers. Exogenous enzymatic preparations such as collagenase, which act in synergy with endogenous enzymes, can be applied to the wound bed8 or eschar edge, encouraging it to separate from healthy tissue. Their penetration of necrotic tissue may be aided by crosshatching it with a scalpel, but this needs to be performed with care. In the case of cavity pressure ulcers with high exudate levels and wet, sloughy tissue, it may be best to consider an alternative method such as alginate dressings or biosurgical debridement (see below). 䡲 Biosurgical debridement uses sterile fly larvae to treat a range of wounds, including pressure ulcers. The sheep blowfly Lucilia sericata (Diptera: Calliphoridae) is the only maggot currently used for this purpose. Maggots secrete proteolytic enzymes that break down and liquefying tissue, which they then ingest. The enzymes produced by this species dissolve only dead tissue in human wounds and the maggots are therefore unable to damage healthy tissue. Maggot secretions also contain chemicals with inherent antimicrobial properties, which may help to combat infection by having an inhibitory effect on the growth of bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). Maggot therapy may result in more rapid deb23

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Scientific Article

ridement and less pain than some other therapies.9 The main disadvantages are that some patients are averse to the use of maggots and that larvae may drown in deeper, heavily exudating pressure ulcers. In sacral pressure ulcers, friction forces may cause dressing slippage and leakage, making the use of larvae more problematic.

Non-selective debridement includes the following techniques: 䡲 Mechanical debridement involves allowing a traditional gauze-type dressing to dry out and adhere to the surface of the wound before manually removing the dressing, debriding any tissue attached to it. This technique is not generally recommended as it is painful and may traumatise healthy or healing tissue. Hydrotherapy is another form of mechanical debridement, but waterborne pathogens may cause contamination or infection as well as tissue maceration. 䡲 Sharp or surgical debridement is the quickest way to remove the necrotic tissue and senescent cells that slow down the tissue repair process, converting a chronic wound into an acute one in the process. Certain conditions, such as advancing cellulitis or sepsis, require urgent surgical debridement, but the pain caused by the procedure and the risk of extensive bleeding must be considered during assessment. This technique requires skill and must always be performed by a competent practitioner, and EPUAP treatment guidelines recommend that sharp debridement should be carried out only if the patient’s blood supply and general health can adequately support healing.3 It should be noted that sharp debridement of larger chronic wounds may result in short-term bacteraemia, which may justify the administration of antibiotic prophylaxis.

INFLAMMATION AND INFECTION CONTROL Infected pressure ulcers can have many serious consequences, including heightened pain and anxiety, a deterioration in the patient’s general condition and a detrimental effect on quality of life. The wound itself will increase in size, producing more exudate, slough and odour, and unresolved infection may ultimately lead to septicaemia and death.

Pressure ulcers are often colonised by multiple organisms, even though there may be no clinical sign of infection. These organisms originate mainly from skin flora or from the bowel as a result of faecal contamination, and typically include staphylococci, streptococci, Proteus mirabilis and Escherichia coli. Over the past decade the increasing incidence of MRSA and multi-resistant pseudomonas infections such as bacteraemia, pneumonia and surgical wound infections have made bacterial resistance a clinical priority in acute care facilities.

It is well documented that chronic wounds are important sources of MRSA colonisation10,11 so pressure ulcers 24

may act as reservoirs for multi-resistant bacterial strains.

However, it can be difficult to determine the bacteriological status of a pressure ulcer because all exposed ulcers are colonised by bacteria. Cultures should be taken only if there are clinical signs of infection, but swab cultures detect surface contamination only and cannot reveal the micro-organisms responsible for tissue infection. Biopsy by aspiration is widely considered the gold standard technique to determine quantitative counts and identify bacteria, but this is often not practical in the clinical setting.12-14 If clinical infection is suspected the full range of relevant laboratory tests must be carried out and critically evaluated. In accordance with the clinician’s experience and the evidence base from the literature, drug susceptibility tests should be considered.

There is an urgent need to rationalise the use of antibiotics when treating infected pressure ulcers as local ischaemia and the presence of devitalised tissue can prevent antibiotics from reaching the wound bed in sufficient doses to be therapeutic. Systemic antibiotics are not recommended for pressure ulcers that exhibit only clinical signs of local infection.3 However, studies have shown a correlation between the incidence of deep-tissue infection and patients with multiple pathologies and poor general health. Systemic antibiotic use should be restricted to the treatment of cellulitis, osteomyelitis and bacteraemia.3 These infections should be treated quickly using carefully selected antibiotics, with the correct dose prescribed for an appropriate period of time.15 The final outcome for infected pressure ulcers depends on achieving a balance between factors that might create further complications and those that resolve existing problems. Host defence mechanisms are particularly important when assessing infected pressure ulcers as patients are often critically ill and have already received several courses of antibiotic therapy as part of their wound management programme. For these reasons all host defence mechanisms must be maximised, including maintaining adequate nutrition and correcting any electrolyte imbalance.

A number of different approaches can be used to reduce the bacterial burden in pressure ulcers to tolerable levels, including the use of antiseptics and systemic antibiotics in conjunction with maintenance debridement. Several types of topical antiseptics are used in wound management, but cadexomer-iodine, povidone-iodine and nanocrystalline silver have shown consistent efficacy in controlling bacterial burden in pressure ulcers and reducing the risk of resistance. These new slow-release antiseptics enable excellent control of resistant microbial species, such as MRSA and vancomycin-resistant enterococci, and can be used effectively as antimicrobial agents.16 Cadexomer-iodine is an antimicrobial made up of a modified starch matrix to which iodine is physically bound. Wound exudate is absorbed by this matrix, while EWMA JOURNAL

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SMITH & NEPHEW Restore the natural balance Højopløst zip-fil sendt til Kailow 30.3.05

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at the same time the iodine component of the dressing is slowly released into the wound in a controlled manner.

Povidone-iodine comprises iodine attached to an inert vinyl polymer matrix, which allows the iodine to be released into the wound in small amounts at a defined rate.

Nanocrystalline silver has a unique technology in terms of silver delivery which results in an effective biological action against a wide range of bacteria. Silver interacts with the cellular membranes of bacteria, causing structural changes that interrupt cell division and interfere with bacterial and electron transportation.

Superficial infection affects mainly grade 2 pressure ulcers and is characterised by the classic signs and symptoms of infection: delayed healing, a change in the colour of the wound bed, abnormal odour, increased exudate and pain, and friable granulation tissue.16 In such cases, the application of topical antiseptics has been shown to be of great benefit in controlling bacterial burden and preventing systemic complications, and is an increasingly valuable alternative to the indiscriminate use of systemic antibiotics. However, antiseptics should not routinely be used to clean pressure ulcers and should be considered only when the bacterial load needs to be controlled, and then only for a limited period of time until the wound is clean and inflammation has been reduced.3 Deep-tissue infection is a frequent complication of grade 3 and 4 pressure ulcers and is characterised by an increase in the temperature of the skin surrounding the wound, tenderness and pain. It is essential to determine the level of infection using a recognised pressure ulcer classification system, such as the EPUAP guidelines,3 to differentiate between superficial and deep-tissue infection because local infection could rapidly progress to systemic involvement. There may also be extended erythema, reaching to the bone and into new areas of breakdown.

Osteomyelitis is a common complication in infected pressure ulcers, with S. aureus the cause in about 60 percent of cases.18 Any pressure ulcer with exposed bone is particularly at risk of osteomyelitis, which should be suspected if clinical signs of infection do not respond to conventional treatment. A diagnosis of osteomyelitis can be confirmed by blood culture and bone biopsy, and a prolonged parenteral therapeutic regimen lasting four to six weeks is often required.

Finally, the risk of infection and cross-contamination can be reduced by effective hand-washing and the use of clean gloves for each patient. Clinicians should remove their gloves and wash their hands after each patient contact. When treating multiple ulcers on the same patient, care should also be taken to attend to the most contaminated ulcer last.3

26

MOISTURE BALANCE Optimal moisture balance at the wound interface is a key element in wound healing. The level of wound moisture is related to several factors, including: – The type of wound – The phase of wound healing – The absorptive capacity of topical dressings.

The management of moisture is an essential aspect of wound bed preparation, but in pressure ulcers this can be particularly problematic due to increased levels of exudate and continence problems. Patients with pressure ulcers are often immobile and confined to bed, and ulcers are usually located on or near bony prominences, sites where the surrounding skin is vulnerable to the effects of moisture such as exudate, perspiration or urine. Skin moisture is one of the most frequently described factors in increased susceptibility to the external forces of pressure, shear and friction.3,5,19,20 Exudate from chronic wounds such as pressure ulcers contains elevated levels of matrix metalloproteinases (MMPs), which can degrade the extracellular matrix, impairing cell migration and connective tissue deposition.21 Growth factors are also inhibited by the MMPs found in chronic wound exudate, so the inflammatory phase often persists and the wound healing process does not progress to the proliferative phase.22

SKIN PROTECTION The amount of exudate produced by pressure ulcers can be controlled by selecting the most appropriate absorptive dressing from a range of suitable dressing, such as hydrocellulars, hydrofibres, calcium-alginates, hydrocolloids, hydrogels and hydropolymers. The choice of dressing should reflect its ability to absorb excess exudate, minimise tissue trauma, debride devitalised tissue and remain in place. When managing skin sensitivity, it is also important to choose a hypoallergenic dressing. Moisture-retentive dressings have been associated with lower levels of reported pain during wound healing.

The ability to manage exudate in a controlled fashion is the key to obtaining optimal moisture balance at the wound interface, which reduces the risk of maceration and of the wound drying out. Maceration results from prolonged exposure of the skin to excessive moisture and is common around the margins of pressure ulcers. Prolonged contact with moisture also inhibits the skin’s barrier function, increasing the risk of exogenous eczema and contact dermatitis.23 Areas of erythema may be present where exudate is in contact with vulnerable skin, often leading to excoriation, the development of irritant dermatitis and new areas of tissue breakdown.

Dressings with adhesive borders should be avoided when treating patients with fragile, oedematous or macEWMA JOURNAL

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erated skin. Dressing performance may also be affected by the effects of friction and shear forces in areas such as the sacrum and heels, where dressings may ruck up and result in additional local pressure, leakage, maceration or skin sensitivity.

Incontinence dermatitis occurs as a result of high levels of moisture, bacterial and enzymatic activity, and the effects of friction. Erythematous maceration can be extremely painful so treatment should be prompt and may require the application of a topical corticosteroid for a limited time to reduce local inflammation before the application of a barrier preparation.24 The maintenance of skin integrity is therefore an important factor in reducing the risk of tissue breakdown.

Practice guidelines advocate that excess moisture as a result of incontinence, perspiration or exudate should be controlled by gently washing the skin with warm water immediately after soiling using mild cleansing agents, and that moisturisers be lightly applied to dry areas.3,5

EPITHELIAL (EDGE) ADVANCEMENT Grade 1 and 2 pressure ulcers are relatively superficial and heal primarily by epithelialisation. However, the presence of reactive hyperaemia, oedema, maceration, excoriation and blistering of the peri-ulcer skin can make it difficult to ascertain the true extent of tissue damage in this grade of pressure ulcer. Deeper wounds, such as grade 3 or 4 pressure ulcers, are characterised by full-thickness skin loss and often involve large cavities with undermining.

These heal by secondary intention as the wound slowly fills in with granulation tissue, a process that depends on effective wound bed preparation. Epithelial advancement from the edge of these wounds is not the primary method of healing.

Wound healing is directly related to the size, shape and stage of the pressure ulcer, but the affected area does not reduce in a linear fashion. However, measuring grade 3 and 4 pressure ulcers at initial assessment and at regular but not too frequent intervals thereafter is a reliable predictor of outcome, and calculating healing rates has been shown to effectively distinguish between healing and non-healing ulcers.25-27 In one study, all pressure ulcers that healed had a percentage area reduction of more than 47% at two weeks, which proved a reliable predictor of healing.25 Best practice recommends that pressure ulcers that do not decrease in size within two weeks of active treatment should be reassessed and treatment modified accordingly.28 However, it should be noted that wound debridement can initially increase the size of a pressure ulcer.

Monitoring the wound size, condition of the surrounding skin and wound margin can provide a valuable indication of the efficacy of preventive treatment and should be carefully documented. The importance of accurately measuring pressure ulcers and assessing the skin 28

is emphasised by the rising number of clinical negligence cases worldwide that involve pressure damage and have resulted in increasing claims for compensation.29

NEW TREATMENTS Several pilot studies are evaluating the effectiveness of new technologies or therapies that aim to promote healing in pressure ulcers and reduce healing times. These include topical negative pressure (TNP) therapy and electromagnetic stimulation.

Topical negative pressure: also known as vacuum-assisted closure, this non–invasive, mechanical wound care treatment uses localised and controlled negative pressure (suction) to support and encourage the wound healing process. The negative pressure is applied in continuous or intermittent cycles via an evacuation tube connected to a computerised and programmable pump, with equal distribution to every surface of the wound ensured by a open-cell polyurethane foam dressing. This process: – provides a moist wound healing environment – reduces periwound oedema, which increases local blood perfusion – stimulates cell proliferation, accelerating the formation of granulation tissue.30,31 These three factors encourage uniform epithelial migration and reduce the risk of infection. However, the delivery of TNP depends on the maintenance of an effective seal. This can be difficult when treating certain body areas, particularly sacral pressure ulcers that are continually subject to shear and friction.

Continuous therapy helps to remove fluid from the wound margins and stagnant fluid from within the wound.

Oedema impairs healing by acting as a reservoir for infection and preventing adequate capillary blood flow to the wound bed, which also increases the risk of infection by limiting the availability of lymphocytes and macrophages thirtytwo. Reducing periwound oedema decreases the bacterial burden, lowering the risk of colonisation, and enables fresh blood to penetrate the wound, stimulating the formation of granulation tissue.

Intermittent therapy acts as a mechanical stretch, resulting in the repeated release of the biochemical messengers that stimulate cellular proliferation and tissue growth, speeding up wound healing.33 Wound size, tissue type, exudate level, odour and the condition of the surrounding skin should be monitored at each dressing change. TNP can be used to achieve complete healing or to prepare the wound bed for surgical closure, particularly as an alternative to traditional saline wet-to-moist dressings in chronic non-healing wounds of considerable depth. It can also be used to encourage the formation of granulation tissue and speed up healing rates 䊳 in complicated chronic or non-healing wounds.

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The presence of malignant lesions, untreated osteomyelitis and necrotic tissue within the wound bed reduce the effectiveness of negative pressure therapy and are contraindicated by the manufacturers. Caution should be exercised if there is bleeding, unstable local haemostasis or distal diabetic foot lesions, or if the patient has been prescribed anticoagulants. Contraindications include the use of TPN in wounds containing fistulae that communicate directly with organs or body cavities.

References

Electromagnetic stimulation: the electrical stimulation of electromagnetic fields has been used for years as an adjuvant therapy to treat pressure ulcers. The body has an endogenous bioelectrical system that can accelerate wound healing by attracting the different types of cells involved in the process to the wound bed. These cells carry either a positive or a negative charge and may be influenced by therapeutic levels of electrical current delivered to the wound from an external source.34 Studies have shown that when compared with controls, both alternating and direct electrical currents produced a reduction in healing time, increased tissue perfusion and promoted collagen formation.35 The Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) stated that electrical stimulation may be considered an adjuvant therapy for grade 1, 2 and 4 pressure ulcers. Data on the effectiveness of these adjuvant therapies in relation to wound healing has been encouraging, but studies suggest that different healing rates are produced with various electrotherapy modalities. Further controlled clinical trials are therefore necessary to establish the optimal parameters for the electrical stimulation of pressure ulcers.

7. Bishop SM, Walker M, Rogers AA, Chen WY. Importance of moisture balance at the wound-dressing interface. J Wound Care 2003; 12(4):125-8.

CONCLUSION Wound bed preparation is a relatively recent concept that is fast becoming established in the treatment of chronic wounds. The TIME framework presents a systematic approach to the local assessment and treatment of non-healing pressure ulcers, which make up the largest subset of chronic wounds in the developed world. The limitation of wound bed preparation is that the concept of TIME does not provide a useful framework for the wider aspects of patient management, including the identification of patients’ at-risk status and pressure redistribution, which is of particular relevance when treating grade 3 and 4 pressure ulcers.

Advances in chronic wound management over the past decade have led to the development and implementation of a range of clinical guidelines on the prevention and treatment of pressure ulcers. The excellent cost-benefit relationship of these procedures has underlined the importance of pressure ulcer management in clinical practice. 䡵 30

1. European Wound Management Association. Position Document: Wound bed preparation in practice. London: MEP Ltd, 2004. Available online at: www.ewma.org 2. Clark M, Defloor T, Bours G. A pilot study of the prevalence of pressure ulcers in European hospitals. In: Clark M (Ed). Pressure Ulcers: Recent advances in tissue viability. Salisbury: Quay Books, 2004; 2: 8-22.

3. European Pressure Ulcer Advisory Panel. Pressure Ulcer Treatment Guidelines.

Oxford: EPUAP, 1999. Available online at: www.epuap.org/gltreatment.html#top 4. Anthony D, Reynolds T, Russell L. An investigation into the use of serum albumin in pressure sore prediction. J Adv Nurs 2000; 32(2): 359-65.

5. National Institute for Clinical Excellence. Inherited Clinical Guideline B: Pressure ulcer risk assessment and prevention. London: NICE, 2001. Available online at: www.nice.org.uk/page.aspx?o=20261 6. European Pressure Ulcer Advisory Panel. Nutritional Guidelines for Pressure Ulcer Prevention and Treatment. Oxford: EPUAP, 2003. Available online at: www.epuap.org/guidelines/index.html

8. Alvarez OM, Fernandez-Obregon A, Rogers RS et al. Chemical debridement of pressure ulcers: a prospective, randomized, comparative trial of collagenase and papain/urea formulations. Wounds 2000; 12(2): 15-25.

9. Sherman RA, Wyle F, Vulpe M. Maggot therapy for treating pressure ulcers in spinal cord injury patients. J Spinal Cord Med 1995; 18(2): 71-4.

10. Cox RA, Bowie PE. Methicillin-resistant Staphylococcus aureus colonization in nursing home residents: a prevalence study in Northamptonshire. J Hosp Infect 1999; 43(2): 115-22.

11. Dunford CE. Methicillin resistant Staphylococcus aureus. Nurs Stand 1997 12; 11(25): 58, 61-2.

12. Heggers JP. Defining infection in chronic wounds: methodology. J Wound Care 1998; 7(9): 452-6.

13. Gilchrist B. Taking a wound swab. Nurs Times 2000; 96(4 Suppl): 2.

14. Dow G. Bacterial swabs and the chronic wound: when, how, and what do they mean? Ostomy Wound Manage 2003; 49(5A Suppl): 8-13.

15. Romanelli M, Magliaro A, Mastronicola D, Siani S. Systemic antimicrobial therapies for pressure ulcers. Ostomy Wound Manage 2003; 49(5A Suppl): 25-9.

16. Lansdown AB. Silver. I: Its antibacterial properties and mechanism of action.

J Wound Care 2002; 11(4):125-30.

17. Cutting KF, White RJ. Criteria for identifying wound infection--revisited.

Ostomy Wound Manage 2005; 51(1): 28-34.

18. Parish LC, Witkowski JA. The infected decubitus ulcer. Int J Dermatol 1989; 28(10): 643-647.

19. Brandeis GH, Ooi WL, Hossain M et al. A longitudinal study of risk factors associated with the formation of pressure ulcers in nursing homes. J Am Geriatr Soc 1994; 42(4): 388-93.

20. Defloor T. The risk of pressure sores: a conceptual scheme. J Clin Nurs 1999; 8(2): 206-16.

21. Stamenkovic I. Extracellular matrix remodelling: the role of matrix metalloproteinases. J Pathol 2003;200(4): 448-64.

22. Yager DR, Nwomeh BC. The proteolytic environment of chronic wounds.

Wound Repair Regen 1999;7(6): 433-41.

23. Cameron J, Wilson C, Powell S et al. Contact dermatitis in leg ulcer patients.

Ostomy Wound Manage 1992; 38(9): 8, 10-1.

24. Newton H, Cameron J. Skin Care in Wound Management. A clinical education in wound management booklet. Holsworthy: Medical Communications UK Ltd; 2004.

25. van Rijswijk L. Full-thickness pressure ulcers: patient and wound healing characteristics. Decubitus 1993; 6(1): 16-21.

26. van Rijswijk L, Polansky M. Predictors of time to healing deep pressure ulcers.

Ostomy Wound Manage 1994; 40(8): 40-2, 44, 46-8 passim.

27. Brown GS. Reporting outcomes for stage IV pressure ulcer healing: a proposal.

Adv Skin Wound Care 2000; 13(6): 277-83.

28. Flanagan M. Wound measurement: can it help us to monitor progression to healing?

J Wound Care 2003; 12(5): 189-94.

29. McKeeney L. Legal issues for the prevention of pressure ulcers.

Journal of Community Nursing 2002; 16(7): 28-30.

30. Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg 1997; 38(6): 553-62.

31. Philbeck TE Jr, Whittington KT, Millsap MH et al. The clinical and cost effectiveness of externally applied negative pressure wound therapy in the treatment of wounds in home healthcare Medicare patients. Ostomy Wound Manage 1999; 45(11): 41-50.

32. Morykwas MJ, Argenta LC. Nonsurgical modalities to enhance healing and care of soft tissue wounds. J South Orthop Assoc 1997; 6(4): 279-88.

33. Fabian TS, Kaufman HJ, Lett ED et al. The evaluation of subatmospheric pressure and hyperbaric oxygen in ischemic full-thickness wound healing. Am Surg 2000; 66(12): 1136-43.

34. Pellett R. The use of electrical stimulation in wound healing: a review of the literature. Acute Care Perspectives 2000; 8(1): 9-15.

35. Gardner Se, Frantz RA. Effect of electrical stimulation on chronic wound healing: a meta-analysis. Wound Rep Reg 1999; 7:495-503.

For further details on using the concept of TIME in wound bed preparation, please refer to the European Wound Management Asssociation, ‘Wound bed preparation in practice. A position document, published by MEP Ltd, London 2004. Available from www.ewma.org

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and Contreet are registered trademarks of Coloplast A/S © 10.04. All rights reserved Coloplast A/S, DK-3050 Humlebaek, Denmark

Contreet Foam Significantly faster healing progress1,2 Up to 60% more cost-effective3 Smart,6 sustained silver release Clinically proven1-5 1. Sibbald R.G. and the Contreet Study Group, Wound Bed Preparation properties of a foam dressing and a silver-containing foam dressing. Poster presented at the 2nd WUWHS meeting in Paris, July 2004.

2. Price P. and the Contreet Study Group, Health-related quality of life aspects after treatment with a foam dressing and a silver-containing foam dressing in chronic leg ulcers. Poster presented at the 2nd WUWHS meeting in Paris, July 2004.

3. Scanlon, E, Münter, K.C., Hart-Hansen, K. Cost-Effectiveness of a Silver Containing Hydro-Activated Foam Dressing in Germany and the UK. Poster presented at the 2nd WUWHS meeting in Paris, July 2004.

4. Lansdown, A.B.G., Jensen, K., Jensen, M.Q. Contreet Foam and Contreet Hydrocolloid: An insight into two new silver-containing dressings. Journal of Wound Care 2003. Vol. 12 (6) p. 205-210.

5. Karlsmark, T., et al. Clinical performance of a new silver dressing, Contreet Foam, for chronic exuding venous leg ulcers, Journal of Wound Care 2003. Vol. 12 (9) p. 351-354 6. Falanga, v. Topical antimicrobials: Can they affect outcomes? The use of a new dressing. ETRS Conference 2001. www.etrs.org / abstracts 02.06.04.

www.coloplast.com · www.contreet.com

Coloplast A/S Holtedam 1 DK-3050 Humlebæk Denmark

Background Article

ARTICLE REVIEW

Sue Bale Professor, Associate Nurse Director R&D Gwent Healthcare NHS Trust Trust Headquarters, Grange House, Llanfrechfa Grange Hospital, Cwmbran, Torfaen, NP44 8YN sue.bale@ gwent.wales.nhs.uk

Title: Randomized clinical trial of four-layer and short-stretch compression bandages for venous ulcers (VenUS 1)

The patientsâ&#x20AC;&#x2122; journey through this trial is clearly outlined in a flow chart that tracks the 988 eligible patients through to trial completion.

Authors: E. A. Nelson, C. P. Iglesias, N. Cullum and D. J. Torgerson Journal: British Journal of Surgery 2004; 91: 1292â&#x20AC;&#x201C;1299

Results 387 of the 988 eligible patients were recruited into this trial and randomized. Nine centres included patients. On inclusion patients in both groups were similar.

The median healing time was 92 (95 per cent confidence interval; 71 to 113) days for the fourlayer group and 126 (95 per cent confidence interval; 95 to 157) days for the short-stretch group.

The difference in the distribution of cumulative healing times between the two groups was not statistically significant (log rank x2 = 2.46, p = 0.117).

In addition, to the type of bandage used, the final best model for the hazard of healing included the treatment centre, number of previous episodes of ulceration, patient weight, natural algorithm of baseline ulcer area, ulcer duration and ankle mobility. Taking these into account there was a statistically significant increase in the probability of healing in the four-layer group.

With regard to secondary outcomes, 112 patients withdrew from the group to which they were randomized (46 in the four-layer group and 66 in the short-stretch group), 20 and 30 respectively were patient-initiated withdrawals.

There were significantly more nurse-initiated withdrawals in the short-stretch group (30 versus 16, p = 0.035). A higher proportion of patients experienced non-bandage-related adverse events, such as health problems, change in ulcer diagnosis or death, in the short-stretch group (39 versus 33), but this was not statistically significant (P = 0.468).

This study is unusual in including healing as a primary outcome measure and this is a very positive aspect of the trial design. However, the different statistical tests employed resulted in both statistical significantly differences being achieved and not achieved for the same data. Although the mathematical arguments are sound, some clinical practitioners and those inexperienced in statistics may be confused. For the purposes of critical analysis and systematic review such discussion regarding statistical analysis is useful

T

he York Group has produced yet another well-designed and executed randomized controlled clinical trial. This Group consistently lead research of an exemplary standard.

This trial focuses on the relative effectiveness and cost-effectiveness of four-layer and short-stretch bandaging systems.

Background Nelson et al define the extent and costs of venous disease in the developed world. They relate this to the role of compression bandages as the mainstay of the effective treatment of patients with venous leg ulceration.

Methods Patients with venous leg ulceration of at least 1cm diameter were included in this trial. Patients were excluded when they were under 18 years of age, had significant arterial disease, diabetes mellitus, were previously unsuccessful using either trial bandage, were unable or unwilling to tolerate compression or could not provide written informed consent.

The randomization procedure was clearly defined and was achieved by employing a concealed, remote telephone randomization service. Patients were thus randomly assigned to either four-layer bandages or short-stretch bandages. The methods of application and use were standardised as were wound care and dressings used.

Health-related quality of life was assessed using the Short Form SF-12, EuroQoL 5D and the Hyland leg and foot questionnaire. The primary endpoint was time to healing of all ulcers on the reference leg, determined as the leg with the largest eligible ulcer. Secondary outcomes included the proportion of ulcers healed at 12 and 24 weeks, withdrawals and adverse events.

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and the researchers should be applauded for doing so in this article.

This study draws attention to issues related to multicentre trials where differences between centres are noted.

Nelson et al do not discount the possible effect centre differences related to nursing factors such as previous bandage experience and bandaging skills. They recommend that future research in this area of practice should include the assessment and management of the bandage application skills of nursing participating in research studies, particularly those of RCT design.

The authors highlight a number of perceived weaknesses in the method. Namely that there was a lack of agreed definitions of ulcer infection, and they noted that this resulted in nurses relying on their clinical judgement to make a diagnosis of infection. In addition, due to the nature of the bandaging intervention it was not possible to blind nurses and patients to the group to which they were randomized. Nelson et al considered that the higher number of nurse-initiated withdrawals could have been due to this lack of blinding. When undertaking wound care RCTs the inability of researchers to blind researchers, patients and nurses to many wound healing interventions is an ongoing challenge to those who wish to employ the best study design.

Nelson et al discuss the results of four other RCTs that compared four-layer with short-stretch bandages.

Such discussion is of great value to readers in assisting them to better understand the usefulness of both types of bandages in clinical practice. Although the sample sizes of these other studies were small, similar healing rates to those achieved in Nelson et al were reported. The tabulation of all five studies facilitates comparison and in doing so provides an excellent additional benefit of this article.

The results of this trial serve to reassure clinicians currently using four-layer bandages of their positive effect on healing. The authors offer recommendations that clinicians consider using short-stretch bandages where patients cannot tolerate the four-layer system, so providing a balanced 䡵 conclusion to this trial.

5th Scientific Meeting

Diabetic Foot Study Group Diabetic Foot Study Group of the European Association for the Study of Diabetes 7-10 September 2005 Chalkidiki, Greece

Advancement of Knowledge on all aspects of Diabetic Foot Care Main subjects during conference: 䊱

䊱

Basic and clinical science Classification, foot clinic, epidemiology Orthopaedic surgery Uraemia, infection Revascularisation, bio-mechanics Wound healing/outcome Diagnostics

䊱

Charcot

䊱

䊱 䊱 䊱 䊱

Please visit www.dfsg.org for futher information.

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ABSTRACTS OF RECENT COCHRANE REVIEWS Wound drainage for caesarean section Gates S, Anderson ER The Cochrane Database of Systematic Reviews 2005 Issue 1. Copyright © 2005 The Cochrane Collaboration.

Published by John Wiley & Sons, Ltd.

Sally Bell-Syer, MSc Review Group Co-ordinator Cochrane Wounds Group Department of Health Sciences Area 4 Seebohm Rowntree Building University of York York, United Kingdom sembs1@york.ac.uk

SYNOPSIS The routine use of wound drains after cesarean section does not appear either beneficial or harmful to the women involved.

Women who have a cesarean section operation (removing the baby by surgery through the mother’s abdomen) sometimes have a wound drain put in place.

The review did not find any differences in the risk of wound infection or other post operative complications between women who had wound drains compared with those who did not, but the evidence is not conclusive.

ABSTRACT Background: Subcutaneous and sub rectus sheath wound drains are sometimes used in women who have undergone caesarean section. The indications for using drains vary by clinician.

Objectives: To compare the effects of using a wound drain with not using a wound drain at caesarean section, and of different types of drain, on maternal health and healthcare resource use.

Main results: Seven trials (1993 women) were included in the review. Meta-analysis found no difference in the risk of wound infection, other wound complications, febrile morbidity or endometritis in women who had wound drains compared with those who did not. There was some evidence that caesarean sections may be about five minutes shorter and that blood loss may be slightly lower when drains were not used.

Reviewers’ conclusions: There is no evidence in the seven small trials included to suggest that the routine use of wound drains at caesarean section confers any benefit on the women involved.

These trials do not answer the question of whether wound drainage is of benefit when haemostasis is not felt to be adequate.

Further large trials are justified using blinded outcome assessment to examine the role of different types of wound drain at caesarean section. Comparing the use of drains in women with different degrees of obesity and in women having first or repeat caesareans and intrapartum or prelabour caesarean sections would be of interest. Women’s views and experience of drains have not been studied in these trials. 䡵

Search strategy: This review draws on the search strategy developed for the Cochrane Wounds Group as a whole. Electronic databases (MEDLINE, EMBASE, Cinahl and CAB Health), and the reference lists of included articles were also searched up to June 2004 Selection criteria: Studies were included if they allocated women to groups at random and they compared any type of wound drain with no wound drainage, or with any other type of drain, in women undergoing caesarean section.

Data collection & analysis: Trials were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. This was done by two reviewers according to pre-stated eligibility criteria.

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EBWM

Selected abstracts from 2nd World Union of Wound Healing Societies meeting

Epidemiology of Venous Ulceration Peter J Franks, Centre for Research & Implementation of Clinical Practice, Thames Valley University, 32-38 Uxbridge Road, London W5 2BS, UK.

Current prevalence estimates of chronic leg ulceration are frequently based on studies undertaken during the 1980’s.

During the last decade, major changes have occurred in the application of evidence based practice, potentially altering the prevalence and patient characteristics of this group.

We have determined the prevalence and aetiology of leg ulceration in a defined geographical population with eight years experience of providing standardised evidence based protocol of care.

Identification, interview and clinical assessment of patients with leg ulceration (>four weeks) within an integrated acute and community leg ulcer service were undertaken. Standardised questionnaire on medical history, ulcer details and non invasive vascular investigation were used to describe aetiology. Estimated prevalence of leg ulceration was determined together with the aetiological classification.

One hundred and thirteen patients were identified in a population of 252,000, giving a crude prevalence of 0.45/1,000 (0.3/1,000 in men, 0.5/1,000 in women).

Rates were highly dependent on age, increasing to 8.29 and 8.06/1,000 in the over 85’s respectively. Of the total 62/112 (55%) had their ulcer for longer than one year.

Uncomplicated venous ulceration was observed in only 59/138 (43%) ulcerated limbs, with a further 21 having ulceration primarily due to arterial disease. Complex aetiologies were present in 48 (35%) limbs, most of whom had venous disease in combination with diabetes (35%), lymphoedema (42%) and rheumatoid arthritis (26%).

The prevalence of chronic leg ulceration is about one third of that predicted by previous studies using similar methodologies in the 1980’s. Patients with ulceration have more complex aetiologies than previously recognised which may be a consequence of both increasing ulcer chronicity and age.

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Self-Care for Leg Ulcers – a new way forward?

E. Nelson, University of York, Department of Health Sciences, Seebohm Rowntree Building, York YO10 5DD, United Kingdom

The new frontline in healthcare is the home, and health professionals need to support self-care, particularly to help people manage chronic conditions. People with venous leg ulcers are mainly treated in primary care, some of them having weekly visits for years. Yet it remains unclear to what extent patients contribute to the healing of their ulcer and whether there is any scope for increasing the extent to which patients could help manage their treatment. Clinicians and patients with other chronic health conditions such as arthritis, heart failure, and asthma have embraced self-management programmes, but there are no programmes for those with chronic venous insufficiency.

This paper will describe a study to assess the barriers and drivers, as well as potential benefits for self-management in the treatment of venous ulceration. The study sets out to answer the following questions: 1. To what extent do nurses and patients currently engage in self-management?

2. What do nurses and patients see as the barriers and drivers for greater self-management in the treatment and prevention of venous ulcers?

3. What patient, professional and organisational preparation is needed to facilitate shared-management of chronic venous insufficiency?

This paper will argue that the management of leg ulceration could draw upon self-management approaches to address the needs of patients in terms of symptom control, relationships with healthcare professionals, and instilling confidence and motivation to live life to the full in spite of their chronic venous insufficiency. *Funded by a Department of Health /PPP Healthcare Primary Care Post-doctoral Fellowship. The opinions expressed are those of the author, not the funder. *

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EWMA Educational Panel

T

Madeleine Flanagan MSc, BSC (HONS), DIP, RGN

he wound education project was initiated in October 2000, its overall aim is to produce a flexible framework for the delivery of education within wound management.

The focus of this initiative is to define the content of specific wound management modules to facilitate development of education and training in counties or areas that currently do not benefit from structured wound healing initiatives. It is envisaged that this approach will ultimately support a range of practice development initiatives in countries across Europe in order to raise awareness of wound care best practise.

The Educational Panel has extended its activities considerably in the past year. As a result the Panel has two new members and is expected to welcome more new members in the coming year.

The panel now consists of:

Aim and Objectives of the EWMA Educational Panel The Panel aims to raise the international profile of wound healing education and research by: – Enhancing the quality of education in wound care for all relevant target groups and subsequently improve wound management in Europe.

– Offering contemporary, interdisciplinary, unbiased education about all aspects of wound management.

– Providing healthcare professionals with the knowledge and skills to equip them to perform their role in the delivery of optimal wound care.

– Presenting a European dimension to education and co-operation between universities and colleges in Europe, who are offering undergraduate and postgraduate programmes in wound healing and management.

– Establishing quality practice and educational standards against which other organisations can evaluate existing wound healing educational initiatives.

Madeleine Flanagan (Chair)

Carol Dealey

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Luc Gryson

Finn Gottrup (Co-chair)

Deborah Hofman

Christina Lindholm

– Achieving European acceptance by developing an educational framework, which harmonises with the European Commission’s educational initiatives in order to disseminate best practice in wound care.

Zena Moore

Katia Furtado New member

Carol Wyndham-White New member

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Modules developed At the present stage, the project has developed the following specific modules: 䡲 Leg Ulcer Management 䡲 Diabetic Foot Ulcer 䡲 Pressure Ulcer Prevention/Management 䡲 Oncology Wounds 䡲 Acute Traumatic Wounds 䡲 Chronic Wound Management

Call for Registration of all Clinical Trials Catherine De Angelis, Jeffrey M. Drazen, Frank A. Frizelle, Charlotte Haug, John Hoey, Richard Horton, Sheldon Kotzin, Christine Laine, Ana Marusic, A. John P.M. Overbeke, Torben V. Schroeder, Hal C. Sox, Martin B. Van Der Weyden.

CMAJ 2004 Sep 14;171(6):606-7

Planned modules 䡲 Wound Assessment 䡲 Burns 䡲 Aspects of Infection control/microbiology 䡲 Clinical Research 䡲 Paediatric Wounds 䡲 Lymphoedema These modules set a benchmark standard for quality wound related education. They can be requested when developing new courses or used to evaluate the quality of existing wound management courses. To ensure that EWMA standards have been met, an audit will be conducted by the Educational Panel to determine eligibility to obtain EWMA approval. Once approval is granted, details of the course and links to the host institution will be included on the EWMA website www.ewma.org in the form of an Directory of EWMA Approved Courses/Programmes. The first entries for the Directory are currently being prepared and are expected to be available in June 2005.

Other activities: Learning Resources – Later this year, the Educational Panel hopes to commence a review of commercially produced learning resources and will include those that meet EWMA’s quality standards in a Directory of Approved Learning Resources on the EWMA website in order to disseminate best practice.

Conferences and Seminars – The Educational Panel will arrange seminars and conferences in relation to the above themes. The next opportunity to join us will be at Stuttgart on the 15. September 2005 at 14.00 and 17. September at 10.30.

For further discussion and information on the opportunities available for involvement in the the Educational Development project or if you have new ideas for the development of wound related education across Europe, please contact Madeleine Flanagan at m.flanagan@herts.ac.uk or the EWMA Organisation Management, Linda Roer 䡵 at l.roer@ccconsult.com.

A

ltruism and trust lie at the heart of research on human subjects. Altruistic individuals volunteer for research because they trust that their participation will contribute to improved health for others and that researchers will minimize risks to participants. In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly. Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavourably on a research sponsor’s product.

Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision- making. Researchers (and journal editors) are generally most enthusiastic about the publication of trials that show either a large effect of a new treatment (positive trials) or equivalence of 2 approaches to treatment (non-inferiority trials). Researchers (and journals) typically are less excited about trials that show that a new treatment is inferior to standard treatment (negative trials) and even less interested in trials that are neither clearly positive nor clearly negative, since inconclusive trials will not in themselves change practice.

Irrespective of their scientific interest, trial results that place financial interests at risk are particularly likely to remain unpublished and hidden from public view. The interests of the sponsor or authors notwithstanding, anyone should be able to learn of any trial existence and its important characteristics.

The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice. Rather than a single trial, it is usually a body of evidence, consisting of many studies, that changes medical practice. When research sponsors or investigators conceal the presence of selected trials, these studies cannot influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-coverage policy. If all trials are registered in a 䊳

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public repository at their inception, every trial existence is part of the public record and the many stakeholders in clinical research can explore the full range of clinical evidence. We are far from this ideal at present, since trial registration is largely voluntary, registry data sets and public access to them vary, and registries contain only a small proportion of trials. In this editorial, published simultaneously in all member journals, the International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness and announces that all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal.

The ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrolment. This policy applies to any clinical trial starting enrolment after July 1, 2005. For trials that began enrolment before this date, the ICMJE member journals will require registration by Sept. 13, 2005, before considering the trial for publication. We speak only for ourselves, but we encourage editors of other biomedical journals to adopt similar policies. For this purpose, the ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase I trials), would be exempt.

The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a notfor-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable. An acceptable registry must include at minimum the following information: – a unique identifying number, – a statement of the intervention (or interventions) and comparison (or comparisons) studied, – a statement of the study hypothesis, – definitions of the primary and secondary outcome measures, – eligibility criteria, – key trial dates (registration date, anticipated or actual start date, anticipated or actual date of last followup, planned or actual date of closure to data entry, and date trial data considered complete),

– target number of subjects, – funding source, – contact information for the principal investigator.

To our knowledge, at present, only www.clinicaltrials.gov, sponsored by the US National Library of Medicine, meets these requirements; Clinical trial registration: a statement from the International Committee of Medical Journal Editors Catherine De Angelis, Jeffrey M. Drazen, Frank A. Frizelle, Charlotte Haug, John Hoey, Richard Horton, Sheldon Kotzin, Christine Laine, Ana Marusic, A. John P. M. Overbeke, Torben V. Schroeder, Hal C. Sox, Martin B. Van Der Weyden DOI:10.1503/cmaj.1041281 there may be other registries, now or in the future, that meet all these requirements.

Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials. Research sponsors may argue that public registration of clinical trials will result in unnecessary bureaucratic delays and destroy their competitive edge by allowing competitors full access to their research plans. We argue that enhanced public confidence in the research enterprise will compensate for the costs of full disclosure. Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial 䡵 registration will advance this goal.

Correspondence to: John Hoey, Editor, CMAJ, 1867 Alta Vista Dr., Ottawa ON K1G 3Y6; fax 613 565-5471; john.hoey@cma.ca This document is not covered by copyright and may be copied or reprinted without permission.

Competing interests: None declared.

All authors are members of the International Committee of Medical Journal Editors: Catherine De Angelis, Editor-in-Chief, JAMA; Jeffrey M. Drazen, Editor-in- Chief, New England Journal of Medicine; Frank A. Frizelle, Editor, The New Zealand Medical Journal; Charlotte Haug, Editor-in-Chief, Norwegian Medical Journal; John Hoey, Editor, CMAJ; Richard Horton, Editor, The Lancet; Sheldon Kotzin, Executive Editor, MEDLINE, National Library of Medicine; Christine Laine, Senior Deputy Editor, Annals of Internal Medicine; Ana Marusic, Editor, Croatian Medical Journal; A. John P.M. Overbeke, Executive Editor, Nederlands, Tijdschrift voor Geneeskunde (Dutch Journal of Medicine); Torben V. Schroeder, Editor, Journal of the Danish Medical Association; Hal C. Sox, Editor, Annals of Internal Medicine; Martin B. Van Der Weyden, Editor, The Medical Journal of Australia.

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Stuttgart 2005 FROM THE LABORATORY TO THE PATIENT: FUTURE ORGANISATION AND CARE OF PROBLEM WOUNDS STUTTGART · GERMANY · SEPTEMBER 15 -17 · 2005

Important Deadlines

Conference Venue

Information

Abstract Submission deadline 31 May 2005

Liederhalle Cultural and Congress Centre Stuttgart, Germany

Registration Secretariat Congress Partner registration@stuttgart2005.org Tel +49-30-204 59 0 Fax +49-30-204 59 50

Commercial Secretariat Congress Consultants commercial@stuttgart2005.org Tel +45 7020 0305 Fax +45 7020 0315

Scientific Secretariat Jutta Schnabel scientific@stuttgart2005.org Tel +49 (0) 7071 298 0336

For further information, please fill out the form at www.stuttgart2005.org

Early Registration before 15 June 2005 Acommodation requests before 20 June 2005

Official Languages The conference will be fully bilingual German/English – English/German

Late registration before 15 August 2005 (on-site registration possible) Conference Dates 15-17 September 2005

ETRS

www.stuttgart2005.org

EWMA Journal Previous Issues

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

Volume 3, no 1, Spring 2003 Multidisciplinary Wound Healing Concepts Finn Gottrup Smoking and Wound Healing Lars Tue Sørensen Wound Healing, Bacteria and Topical Therapies Keith F. Cutting The Use of the Laplace Equation in the Calculation of Sub-bandage Pressure Steve Thomas Wounds in Art Christina Lindholm Was it Art or Science?

Carol Dealey

English

Using Support Surfaces to Manage Tissue Integrity David M. Brienza, Mary Jo Geyer Choosing the Right Support Surface JoAnn Maklebust Pressure Ulcers in Secondary Care: Incidence, Prevalence, and Relevance Jürgen Stausberg, Knut Kröger, Irene Maier, Helmut Schneider, Wolfgang Niebel Cutaneous Anthrax: Conservative or Surgical Treatment?

Janusz J. Godyn, Luis Reyes, Richard Siderits, Anup Hazra Helpful Hints for Hyperbaric Oxygen and Drugs/ Biologicals Reimbursement Kathleen D. Schaum Skin Care of the Incontinent Patient Mikel Gray What is… Evidence-Based Medicine?

Laura Bolton The Role of Nutrition in Tag F-314 Compliance Mary Ellen Posthauer Staging Necrotic Wounds According to Health Care Setting Elizabeth A. Ayello The NPUAP Support Surface Initiative Laura Edsberg, Mary Jo Geyer, Karen Zulkowski

Volume 3, no 2, Fall 2003 Diabetic foot ulcer metabolism Lars B Stolle, Per Reigels Nielsen Clinical evaluation of L-Mesitran® – a honey-based wound ointment Jan Vandeputte, P.H. Van Waeyenberge Research on wound healing: The integration of a basic research laboratory into a clinical wound care unit Stephan Coerper, M.Witte, M. Schäffer, C. Wicke, S. Wagner, G. Köveker, H.D. Becke The prevalence of leg ulceration: a review of the literature Michelle Briggs, S José Closs Experiences of two (first-time) Cochrane reviewers Gabriele Schlömer, Gero Langer Finnish Volume 4, no 1, Spring 2004 Prevalence Investigation of Pressure Ulcers Susan Bermark, Vonnie Zimmerdahl, Kirsten Müller Histological examination of the distribution change of myofibroblasts in wound contraction Ai Tanaka Problematic recurrent ulcers: A case of calciphylaxis in a dialyzed patient Massimo Bulckaen, A. Capitanini, I. Petrone, N. Petrini, Del Corso, F. Giuntoli, A. Rossi The TELER System in Wound Care Research and Post Market Surveillance Natasha Browne et al.

The Contribution of French Surgeons to Wound Healing in Medieval and Renaissance Europe Carol Dealey

Haava, no 1, 2005 Evidence Based Wound Management – literature review Helvi Hietanen Development of Finnish Pressure Ulcer Risk Assessment Mervi Lepistö Evidence Based or Traditional Wound Treatment Virve Koljonen Wound Management in Triage – Experiences of Asian Tsunami Catastrophe Helvi Hietanen, Virve Koljonen, Kirsi Mikkonen, Ulla Elfving-Little Finnish Research and Literature in Wound Management in 1990-2000 Helvi Hietanen Effectiveness of Prevention, Treatment and Rehabilitation Antti Malmivaara Nursing Science and Qualitative Research in the Development of Wound Management Jari Kylmä, Merja Nikkonen, Taru Valjakka Iodine – Harmful of Good in Local Treatment of Wounds?

Ansa Iivanainen, Helvi Hietanen

Volume 5, no 1, Spring 2005 Word from the president Peter Vowden Advanced treatments for non-healing chronic wound Vincent Falanga Watch the pressure – It drops!

Anne Marie Larsen, Inger Futtrup Cost Effectiveness of Dressing Materials Peter J. Franks Wound healing: Historical Aspects Finn Gottrup, David Leaper Wound healing and fine art: What is possible to learn?

Massimo Papi

Advances in Skin & Wound Care, Vol 18, no 3, April 2005 www.woundcarejournal.com

Spanish

Helcos Vol 16, no 1, 2005 The quest for scientific evidence in pressure ulcers: five years, one goal, multiple ways Protective bandage or hydrocellular dressing to prevent pressure ulcers on heels?

Previous issues can be acquired for €7,50 per copy. Please contact: Congress Consultants, Martensens Allé 8, DK-1828 Frederiksberg C, Denmark Tel: + 45 7020 0305, Fax: + 45 7020 0315, ewma@ewma.org The EWMA Journals can also be downloaded free of charge from www.ewma.org

40

EWMA JOURNAL

2005 VOL 5 NO 1

EWMA

English

The International Journal of Lower Extremity Wounds Vol 3, no 4, December 2004 http://ijlew.sagepub.com

English

Whither Progress in the Diabetic Foot Clinical and Research?

Case series of use of Manuka honey in leg ulceration Georgina Gethin, Seamus Cowman Risk assessment of the diabetic foot and wound Stephanie Wu, David G Armstrong Evaluation of Tielle hydropolymer dressings in the management of chronic exuding wounds in primary care Curt Diehm, Holger Lawall Health-related quality of life with lymphoedema: a review of the literature Philip A Morgan, Peter J Franks, Christine J Moffatt The silver-releasing foam dressing, Contreet Foam, promotes faster healing of critically colonised venous leg ulcers: a randomised, controlled trial Bo Jørgensen, Patricia Price, Klaus E Andersen, Finn Gottrup, Niels Bech-Thomsen, Elizabeth Scanlon, Robert Kirsner, Henriette Rheinen, Jytte Roed-Petersen, Marco Romanelli, Gregor Jemec, David J Leaper, Martino Ha Neumann, Joep Veraart, Stefan Coerper, Rikke H Agerslev, Susanne H Bendz, Jan R Larsen, R Gary Sibbald Pressure ulcer-like presacral gummata in a patient with tertiary syphilis Uwe Wollina, André Koch, Mohammed Badawy Abdel-Naser, Jacqueline Schönlebe Pressure sores with associated spasticity: a clinical challenge Bishara S Atiyeh, Shady N Hayek Hip ulcer secondary to foreign body reaction and vacuum-assisted closure therapy: report of a case Gabriela Moreno-Coutiño, Guadalupe Estrada-Chávez, Judith Domínguez-Cherit

Pressure Offloading and “Advanced” Wound Healing: Isn’t It Finally Time for an Arranged Marriage?

Minimally Invasive Treatment for Varicose Veins: A Review of Endovenous Laser Treatment and Radiofrequency Ablation The Venous Ulcer and the Superficial Venous Reflux Inflammation and Wound Healing: The Role of Bacteria in the Immuno-Regulation of Wound Healing A Hospital-Based Survey of Risk Factors for Diabetic Foot Ulceration in Northern Thailand Deep Infection After Ilioinguinal Node Dissection: Vacuum-Assisted Closure Therapy?

The Clinical Evaluation of Pterocarpus santalinus Linn.

Ointment on Lower Extremity Wounds – A Preliminary Report

English

Journal of Wound Care, April issue, Vol 14, No 4. www.journalofwoundcare.com; jwc@emap.com Evaluation of the quality of venous leg ulcer care given in a multidisciplinary specialist centre M.L. Kjaer, L.T. Sorensen T. Karlsmark et al.

A comparison of laser Doppler imaging with other measurement techniques to assess burn depth S.J. Hemington-Gorse Silver absorption and antibacterial efficacy of silver dressings A.B.G Lansdown, A. Williams, S. Chandler, S. Benfield Estimating costs of pressure area management based on a survey of ulcer care in one Irish hospital G. Gethin, J. Jordan-O’Brien, Z. Moore Using topical negative pressure therapy to resolve wound failure following perineal resection P. Jethwa Does the use of a cleanser on skin surrounding pressure ulcers in older people promote healing?

C. Konya, H. Sanada, J. Sugama, M. Okuwa, A. Kitagawa Skin grafting techniques for soft-tissue coverage of diabetic foot and ankle wounds T.S. Roukis, T. Zgonis Using cycloidal vibration to heal venous leg ulcers: a cost-analysis based on retrospective data G.W. Cherry, T.J. Ryan Wound pain: the need for a more understanding approach C.S. Clay, W.Y. J. Chen The role of pressure-redistributing equipment in the prevention and management of pressure ulcers J. Bell

Scandinavian

EWMA JOURNAL

Wounds (SÅR) Vol 13, no 1, 2005 www.saar.dk Measurement of Life Quality on Leg Ulcer Patients Lis Ribu, Astris Wahl Leg Ulcer Healing with a New Super Absorbing Bandage Øystein Vatne Intermittent Pneumatic Compression Mikael Bitsch, Susan Nørregaard, Per Holstein An Intern Supplementary Training of Foot Therapists Jane Bremer Holgersen Is the communication between the Therapists good enough?

Anne Jensen Better Wound Healing for Less Money!

Birthe Malmos

2005 VOL 5 NO 1

International Wound Journal March 2005, Volume 2 Issue 1, Page 1-83 www.blackwellpublishing.com

German

Zeitschrift für Wundheilung, Issue 2/2005 www.dgfw.de Article with english abstract available are:

Metabolic Kinetics of cultivated Human Fibroblasts as an Indicator of Pathological Wound Healing – Preliminary Results H. Seyhan, R. E. Horch, S. Schulte-Mosgau and J. Kopp Affecting the Wound healing prcess of Chronic Ulcera by an Octenidine based wound antiseptics – An explorative Analysis of a controlled clinical Trial W. Vanscheidt, M. Bär, T.W. May and J. Siebert Scarring and contracting in Normal Wound Healing If existing A. Fette English abstracts are The Importance of Psychological Factors in the Treatment available from www.mhp-verlag.de of Chronic Wounds K. Chr. Münter

EWMA values your opinion and would like to invite all readers to participate in shaping the organisation.

Please submit possible topics for future conference sessions.

EWMA is also interested in receiving book reviews, articles etc.

Please contact the Journal Secretariat at ewma@ewma.org

41

Author Guidelines

T

his Journal is the official publication of The European Wound Management Association.

The Journal publishes original scientific and/or clinical papers on the broadly defined topics of wound management, education and research.

Manuscripts will be accepted from any country and should normally be submitted in English (contact the editor for guidance regarding this), and will be subject to copyediting before publication.

SUBMISSION OF MANUSCRIPTS Two copies of each paper, including illustrations, should be submitted by email or hard copy / CD Rom to the EWMA journal Secretariat Office at the following address: EWMA Journal, Congress Consultants, Martensens Allé 8, DK-1828 Frederiksberg C, Denmark ewma@ewma.org. www.ewma.org Tel: +45 70 20 03 05. Fax: +45 70 20 03 15 Please note that illustrations should be forwarded in graphical formats i.g. .jpg, .psd, .ai, .tiff etc in a high resolution (300 ppi at 100% enlargement).

Authors may suggest the names of two reviewers for the manuscript; however, selection of the referees will be determined by the Editor.

Abstracts of oral or poster presentation are not considered to constitute prior publication.

COPYRIGHT OF ALL PAPERS IS VESTED IN EWMA All manuscripts must be accompanied by a letter with the following statement signed by all authors: „The undersigned authors transfer all copyright ownership of the manuscript [insert name of article here] to EWMA in the event the work is published.

The undersigned authors warrant that the article is original, does not infringe upon any copyright or other proprietary right of any third party, is not under consideration by another journal, and has not been previously published.“ Copyright assignment is a condition of publication and papers will not be published unless copyright has been assigned.

It is the responsibility of the authors to disclose to the Editor any significant financial interests they may have in products mentioned in their manuscript. This information will be deemed confidential and will only be disclosed to manuscript reviewers if, in the opinion of the Editor, the information is directly pertinent for an informed review.

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GENERAL INSTRUCTIONS The manuscript should be typed on white paper, A4 size.

Type on only one side of the paper.

Use double-spacing throughout, including title page, abstract, text, acknowledgments, references, footnotes, tables, and legends for illustrations.

Number pages consecutively, beginning with the title page.

Title page: The title page will carry (a) the title of the article, which should be concise but informative; (b) first name, middle initial, and last name of each author, with highest academic degree(s), professional qualification and institutional affiliation; (c) name of department(s) and institution(s) to which the work should be attributed; (d) name, address, telephone, fax number, and email address of author responsible for correspondence about the manuscript; (e) name and address of author to whom requests for reprints should be addressed.

Authorship: All persons designated as authors must qualify for authorship. Each author should have participated sufficiently in the work to take public responsibility for the content. Participation solely in the acquisition of funding or the collection of data does not justify authorship. General supervision of the research group is also not sufficient for authorship.

Abstract: The second page will carry an abstract of no more than 200 words. The abstract should state the purposes of the investigation, basic procedures, main findings, BE SPECIFIC, and the principal conclusions. Emphasize new or unique aspects of the investigation. Abbreviations may not be used in the abstract.

Text: The text of the manuscript should be divided into the following sections with headings: Introduction, Methods, Results, Discussion.

Longer articles may be further divided with appropriate subheadings.

For information regarding ethical considerations; Statistics; Study Type; Acknowledgments; References; Illustrations etc. please visit the web site www.ewma.org or contact the 䡵 EWMA journal Secretariat, ewma@ewma.org

EWMA JOURNAL

2005 VOL 5 NO 1

EWMA

EWMA Corporate Sponsor Contact Data Corporate A

Coloplast Holtedam 1-3 DK-3050 Humlebæk Denmark Tel: +45 49 11 15 88 Fax: +45 49 11 15 80 www.coloplast.com

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

Ethicon GmbH Johnson & Johnson Wound Management Oststraße 1 22844 Norderstedt Germany Tel: +49 40 52207 230 Fax: +49 40 52207 823 www.jnjgateway.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.kcimedical.com

EWMA JOURNAL

2005 VOL 5 NO 1

Corporate B

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

Mölnlycke Health Care Ab Box 13080 402 52 Göteborg, Sweden Tel: +46 31 722 30 00 Fax: +46 31 722 34 08 www.tendra.com

Smith & Nephew Po Box 81, Hessle Road HU3 2BN Hull, United Kingdom Tel: +44 (0) 1482 225 181 Fax: +44 (0) 1482 328 326 www.smith-nephew.com

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

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

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

Use the EWMA Journal to profile your company

Deadline for advertising in the next issue is 1. June 2005.

43

Conferences

Conference Calendar Conference

Month

Date Place

Country

18th Annual Symposium on Advanced Wound Care

Apr

21-24 California

United States

Tissue Viability Society Meeting

May

4

Aberdeen

Scotland

EPUAP 8th European Pressure Ulcer Advisory Panel Open Meeting

May

5-7

Aberdeen

Scotland

May

18

Chicago / Illinois

US

Wound Healing Society 2005

Theme

Marketing Opportunities

Wound Conference

May

20-21 Koblenz

Germany

WOCN Society 37th Annual Conference

Jun

12-16 Las vegas

US

Wounds-UK 2005 Summer Conference

Jun

European Wound Healing Summer School

Jun

29

Manchester

UK

22-25 Oxford

United Kingdom

15-17 Stuttgart

Germany

Sep

7-10 Chalkidiki

Greece

Wound Care Consultant Soeciety

Nov

4-5

Czech Wound Management Society

Nov

Stuttgart 2005 EWMA, DGfW and ETRS

From the laboratory to the Sep patient: future organization and care of problem wounds

DFSG - 5th Scientific Meeting

CAWC 11th annual

Bridging wound care

Wounds-UK 2005 UWCNE

Wound Care Update 2005

1st Scientific Congress of PWMA

Utrecht

The Netherlands

Hradec Králové

Czech Republic

Nov

12-15 Montreal

Canada

Nov

14-16 Harrogate

UK

Nov

16-17 Washington

US

Nov

24-27

Poland

2006 6th National Australian Wound Management Association Conference

Mar

15-18 Canberra

Australia

European Wound Management Association

May

18-20 Prague

Czech Republic

22. Congrès Mondial de l’Union Internationale d’Angiologie

Jun

24-28 Lisbonne

Portugal

EWMA Position Document 2004 Editor: Christine Moffatt.

Languages: English, French, German, Italian and Spanish.

See www.ewma.org Wound bed preparation in practice The third EWMA position document arose out of the need to focus on the factors that influence healing and why a significant proportion of chronic wounds fail to heal even with the highest standards of care.

The document, entitled ‘Wound bed preparation in practice’ seeks to advance understanding of the concept of wound bed preparation by examining how the four components of the ‘T.I.M.E.’ model (Tissue management; Inflammation and infection control; Moisture balance and Epithelial (edge) advancement) are translated into the practical management of different wound types, each presenting with unique clinical challenges.

The document has been made possible by a educational grant from Smith & Nephew. It has been published in English, French, German, Italian and Spanish and is available to download from the EWMA website (www.ewma.org) as a pdf.

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Previous Position Documents:

EWMA JOURNAL

2005 VOL 5 NO 1

Organisations

Wound Management in Poland PWMA Polish Wound Management Association

Prof. Zbigniew Rybak, President zrybak@poczta.onet.pl

– facing challenges of XXI century Poland – a country with population of 38 million people and estimated number of 500 000 patients with chronic wounds annually has been trying for last three years to build system of advanced wound care.

As sometimes happens with such major undertakings, the further we go with building a unified approach to wound care we find that the new boundaries and issues emerge and try to push us away from the route we have chosen. The goal of Polish Wound Management Association is to change practice in care for people with wounds in Poland.

As the problem of modern wound management – or actually – lack of knowledge amongst physicians in the majority of the Central and Eastern European countries is common, our struggle might be an interesting experience to all of EWMA members who still hesitate if they should claim more support for developing wound care from local authorities and scientific societies.

Wojciech Stras Secretary PWMA ptlr_sekretarz@op.pl Contact address: Polskie Towarzystwo Leczenia Ran, Krochmalna Str. 32a 00-864 Warsaw, Poland

The Polish Wound Management Association was established with aim to educate health professionals on modern wound care and to change current practice in order to utilise the systems and methods commonly used in countries as the United Kingdom and Sweden.

We have had a plan in place, with the basic objectives to: educate different specialist groups, organize conferences and workshops, influence education of doctors and nurses to place the wound healing blocks in their study courses and post-graduate education. Finally we also wanted to build an organisational system to endorse wound care progress and outcomes and to allow more patients receiving clinically and cost effective proven treatment.

We have recognized the need for constant dialogue with local authorities and payers to establish consensus on understanding the basic benefits for all parties involved in wound management i.e. payers, physicians, nurses, and the patients. The latter of course should always be in the centre of our focus and we have tried to maintain that as a key element of our activities.

Very quickly we realized that it is very difficult to provide effective wound care in a coun-

try where elderly people – as we all know they happen to be main victim of chronic ulceration – are poor and the Health Care system is not offering them access to clinically effective wound treatment. In simple words we have a reimbursement system where drugs and medical devices can be collected by patients either after co-paying some small fee or covering 3050% of the retail price of the products – it depends upon what type of reimbursement list a particular product enters. The decision on that is made by Ministry of Health, which places the products on different reimbursement lists.

Hence reimbursement exists but the co-payment rate varies depending on to which list the particular product is allocated.

In the case of dressings it is usually the 50% co-payment, but the situation is more complicated because of price limitation – the price is not even based on the price of the cheapest products but often on the price of the cheapest 1cm2 of any dressing!!! Not even looking deeper into the system solutions in Poland we can state that the reimbursement often covers not more than 30-40% of retail price and thus the burden patients have to shoulder is vast.

We have started the discussion with the Ministry of Health to work out the better and more cost effective solutions but it has not produced any results so far.

Education is one of key elements of our constitutional targets. In this area we have really done a great deal. We are very proud of the great interest in wound care that has risen amongst doctors and nurses in Poland.

In October 2004 we organized the Second Conference of the Polish Wound Management Association. This was the first conference organized solely by us without sharing the organizational burden with the Polish Phlebological Association as we did in March 2004.

During that conference we had an extremely successful session with great participation of Peter Vowden, Christine Moffat and Finn Gottrup. We must admit that although it was planned that our second conference be a regional educational event, the interest amongst physicians and nurses exceeded our expectations. It was great to learn that after just three years of PWMA’s presence there was already 䊳

EWMA JOURNAL

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45

significant change in the understanding of wound care amongst a growing number of practitioners. Medical professionals in Poland have started to recognize the issue of chronic wounds, see the need for improvement in these areas and understand that patients’ misery related to chronic ulceration can be effectively diminished.

Certainly, the participation of President Elect of EWMA Peter Franks had great impact on the attractiveness of the meeting. It was also extremely important for our association that Peter participated in the meeting that took place on the conference eve related to reimbursement issues in Poland. At that meeting we managed to gather several national consultants in key medical specialties related to wound management and also few KOL – Professors in different surgical areas. We also expected the participation of the Ministry of Health but despite confirmation of participation, the representative of the MoH failed to appear. Peter Franks made a presentation at that meeting and, after his talk, there was a common understanding and approval for the superiority of modern management in relation to cost and Quality of Life. All the Professors who had participated in the meeting signed the letter addressed to Ministry of Health in Poland claiming better reimbursement for wound dressings.

After the success of these conferences we were much braver in undertaking preparations for the next educational event, but this time organized on a national or maybe even international level.

As result on 24-27 November 2005 there will be held in Poznan, Poland the 1st Scientific-Educational Congress of the Polish Wound Management Association – Wound Healing a Challenge of the XXI Century.

We plan to gather around 700 participants from Poland and we have started wondering if during the Congress – a

46

significant part of which will be held in English – we could organize a central European meeting of wound healing societies to start discussion on future of wound care in our part of Europe and the reimbursement issues across our countries.

We would be happy for any interested societies from central and Eastern Europe to approach us to discuss it further.

In the last part of this review, we wish to show our approach to the organization of wound care services in Poland. One of the initial plans we had was to organize and then facilitate an organization of Wound Healing Centers (WHC) in several regions of Poland.

However, we came to the conclusion that with such a huge number of ulcers in our country and the geographical spread of patients with wounds we cannot hope for a system of wound specialists to match the needs of all the patients. At least, we were sure we couldn’t bring to market the relevant number of such specialists in a short time. Our decision then was to establish a system of WHC, which would work through collaboration between many regional general practitioners surgeries.

The whole system would work as follows: Our association in collaboration with the General Practitioners Association organizes a series of course for GPs in the whole country on the basics of wound management.

In each region a Wound Healing Centre is built – that would be formed of a group of specialists working in outpatients’ clinics who would have a deeper knowledge and practice in wound management. In WHC the experience would be much more significant as they would be looking after tens of patients in each such unit whereas an average GP has 3-6 patients with wounds. This way we would have covered the basic needs of wound management in the majority of populations and we also would have a system in place

where the more complicated cases would be referred and managed properly. The WHC would also provide continuous education in wound care in areas of their geographical location.

We still believe that the approach is a good one but after several attempts to develop it we came to the conclusion that, without significant external financing, we cannot bring this system to life and build it in the majority of the country.

In conclusion, we have had certain successes in changing the environment in Poland and building awareness amongst all parties involved in wound care. As a result we are starting to have a system that allows hospitals and out-patients’ clinics to manage wounds and collect the payment for procedures related specifically to wound management. These procedures are listed on the procedure list issued by our National Health Care Fund – there is just one health insurer in Poland.

That was one of the major changes towards building the system of care for wounds, which included the specifics of this clinical entity.

We understand that there are still so many things to do in Poland to make wound management match the best standards and that we have plenty of work for next ten years.

We must find some more convincing arguments that would convince our Ministry of Health that it is worth reimbursing modern wound management items because it allows for savings in the health care system.

We have definitely had some successes but also some failures. We hope that in the future we will have more support from EWMA and also that we will have a chance to establish collaboration with other central European societies to put bigger pressure on our health authorities to change the system towards better wound care for patients.

EWMA JOURNAL

2005 VOL 5 NO 1

Organisations

Russian Federation (Enclave)

Baltic Sea

Poland T

Lithuania

Gdansk

he Republic of Poland is situated in northeastern Europe, bordering Germany, the Czech Republic and Slovakia to the West and South with Russia to the north and Lithuania, Belarus and the Ukraine to the East.

Szczecin Warszawa Poznan Lodz

Germany

Poland is a country of varied topography including the shores of the Baltic Sea to the north, the Sudeten and Carpathian Mountains along the southern borders and the Tatra Range of mountains in the central regions. These mountains are the only range of Polish mountains with an alpine character.

The Tatra Range is home to Poland’s highest peak – Mount Rysy at 2,499 meters above sea level. In addition to high mountains, there are hundreds of lakes hidden away in the Pomeranian and Mazurian Lakelands where beautiful lakes are found amidst picturesque hills and beautiful forests. The largest is Lake Sniardwy, which occupies a surface area of 109,700 hectares.

The Polish climate is balanced between the marine mild climate of Western Europe (mild summers and winters, lot of rain, clouds) and the continental climate of Eastern Europe (with warm dry summers and cold winters). The coldest area is in the northeast and the warmest is the southwest. During the summer, the average temperature in July is 76°F (24°C) and the coldest winter months are January and February with the average January temperature dropping to 30 °F (-5°C). A benefit of this is that the huge winter snowfalls offer good conditions for winter sports enthusiasts.

During the past couple of centuries Poland has been a battleground for several wars. As a nation, Poland gained independence in 1918 following WWI, only to be overrun by German and Russian forces in September 1939 and, after WWII, to become a soviet satellite state. In 1956 the leaders of the eastern block signed the Warsaw Pact, the soviet counter piece to NATO, in Warsaw. During the 1980s labour turmoil in the large shipyards of Gdansk, on the Baltic Sea, resulted in the formation of “Solidarity”. A trade union that, over the next 10 years, became a strong political force in Poland and which by 1989 achieved success in the parliamentary elections with an elected president.

The leader of Solidarity, Lech Walesa, was the first elected president.

After the end of the cold war, Poland joined NATO in 1999 and the EU in 2004.

EWMA JOURNAL

2005 VOL 5 NO 1

Belarus

Wroclaw Krakow Czech Republic

Ukraine

Slovakia

Official name: Republic of Poland (in Polish: Rzeczpospolita Polska) Area: 312,685 sq km Population: 38.62 million (2003 estimate) Government type: Republic Head of State President Aleksander Kwasniewski Head of Government: Prime Minister Marek Belka Well-known Poles: Pope John Paul II, Former President Lech Walesa Language Polish Religion 95% Roman Catholics Capital Warsaw (population 1.75 million) Important cities: Gdansk, Krakow Currency Zloty (zl), 1 zl ~ 0.25 € (January 2005) GDP per capita 9,700 US$, estimated growth 3.7% (2003) Labour force 16.92 million (2003) Unemployment 20% (2003) Additional information: www.pl-info.net, www.polandtour.org, www.poland.pl Sources: CIA World Fact book, Lonely Planet, National Polish Tourist Office

47

DGfW DGfW Deutsche Gesellschaft für Wundheilung und Wundbehandlung e.V.

Horst Dieter Becker President

The German society for Wound Healing and Wound Treatment (DGfW e.V.) was created as an interdisciplinary scientific organisation in Wiesbaden in 1994. A goal of the founders was to create an organisation which supports knowledge transfer between research and practice for the improved treatment of acute and chronic wounds. The society pursues exclusively non-profit purposes and altruistic activities. An aim of the society is to promote the relations of wound healing and wound treatment to practice, research and science.

Stuttgart 2005

DGfW Council Horst Dieter Becker President

EWMA 2006 · PRAGUE

Ralf-Uwe Peter Vice-President Martin Koschnick Treasurer Roswitha Faller Bernd AssenheimmerWalter Wetzel-Roth DGfW Contact Information: c/o Brigitte Nink-Grebe Glaubrechtstraße 7 D-35392 Giessen Germany Tel: +49 (0) 641 686 8518 Fax: +49 (0) 641 686 8517 dgfw@dgfw.de www.dgfw.de

The DGfW e.V. communicates progress in diagnostics, therapy and prevention to the public. An annual national conference is held

by DGfW, who also supports regional initiatives by acting as an umbrella organisation.

DGfW promotes the cooperation between all occupational groups within wound healing and supports the interlinking between inpatient and outpatient treatment.

The organisation publishes the bimonthly journal Journal of Wound Healing/Zeitschrift für Wundheilung.

CZECH REPUBLIC 18 -20 MAY · 2006

48

EWMA JOURNAL

2005 VOL 5 NO 1

Organisations

Samtök um Sárameðferð IWHS Icelandic Wound Healing Society

Guðbjörg Pálsdóttir Primary Healthcare Nurse in Reykjavik sums@sums-is.org www.sums-is.org

Icelandic Wound Healing Society established on October the 28th 2004 In recent years the idea of establishing a wound healing society in Iceland has been discussed more and more often, especially among nurses.

When Baldur Tumi Baldursson, dermatologist and his colleague from Össur hf in Iceland attended the WUWHS conference in Paris in July 2004, they met Finn Gottrup and Henrik Nielsen from EWMA and things started to develop. In connection with this meeting they proposed to start preparation for a wound healing society in cooperation with and assistance from EWMA. The firm Össur hf volunteered to assist financially with the first steps, a meeting with Finn Gottrup and Henrik Nielsen in Reykjavík in August. People from different disciplines and representatives from firms dealing in wound healing products were invited to this meeting.

They all showed interest in the subject and the meeting was very successful.

Finn Gottrup gave a short presentation on wounds, where he drew attention to the high cost to the community and how important multidisciplinary cooperation is in this connection. Henrik Nielsen introduced EWMA and EWMA’s function and how they could be of assistance in starting an Icelandic Wound Healing Society.

At the meeting a preparative group of ten people was set up. This group consisted of people from the industry and different professions with different specialities, a docent in nursing at the Faculty of Nursing of the Univer-

Excellent keynote speakers: Finn Gottrup and Kirsten Müller from Danish Wound Healing Society, Christine Moffatt from England, and Henrik Nielsen represented EWMA.

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sity of Iceland, a dermatologist, vascular surgeon and a physiotherapist. The group started its work by discussing the objectives of establishing a wound healing society. There are many professionals, many different institutes in the health care system with great knowledge and ideas. But often they work rather in isolation.

The group came to the conclusion that it was of great importance to enhance multidisciplinary cooperation and according to this to gather, expand and spread knowledge about wound healing and treatment of wounds. It was agreed to to hold a symposium about wounds and to establish an Icelandic wound healing society in connection with the symposium.

The symposium was held on October 28, 2004, with excellent keynote speakers.

They were Christine Moffatt from England, Finn Gottrup and Kirsten Müller from Denmark. Henrik Nielsen represented EWMA. I want to stress that Kirsten Müller has been a unique support and inspiration for Icelandic nurses interested in wound healing.

The day of the symposium was a great success. 130 participated, everyone yearning to learn about wounds. At the end of the day The Icelandic Wound Healing Society, Samtök um sárameðferð (www.sums-is.org) had been established with 80 members. We are aware of a growing interest in wound healing amongst Icelandic health care professionals and we are looking forward to cooperate with EWMA and other wound healing societies in Europe and elsewhere.

The council of the newly established wound healing society in Iceland: Jón Hjaltalin Ólafsson, Karl Logason, Jóna Kristjánsdóttir, Adalheidur Thórarinsdóttir, Herborg Ívarsdóttir and Guðbjörg Pálsdóttir.

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Co-operating Organisations AISLeC Associazione Infermieristica per lo Studio Lesioni Cutanee Italian Nurse Association for the Study of Cutaneous Wounds www.aislec.it

AIUC Associazione Italiana Ulcere Cutanee Italian Association for Cutaneous Ulcers www.aiuc.it

APTF Portuguese Wound Management Association www.aptferidas.no.sapo.pt

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

CNC/BFW Wound Management Organisation www.befewo.org www.wondzorg.be

CSLR Czech Wound Management Society www.cslr.cz

DGfW Deutsche Gesellschaft für Wundheilung www.dgfw.de Danish Wound Healing Society

DWHS Danish Wound Healing Society www.dgfw.de

FWCS Finnish Wound Care Society www.suomenhaavanhoitoyhdistys.fi

GAIF Grupo Associativo de Investigacão em Feridas www.gaif.net

GNEAUPP Grupo Nacional para el Estudio y Asesoramiente en Ulceras por Presión y Heridas Crónicas www.gneaupp.org

IWHS Iceland Wound Healing Society www.sums-is.org

LBAA Latvian Wound Treating Organisation sergejs.kolesnikovs@molnlycke.net

LSN The Lymphoedema Support Network www.lymphoedema.org/lsn

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Organisations

LUF The Leg Ulcer Forum www.legulcerforum.org

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

PWMA Polish Wound Management Association

SAfW Swiss Association for Wound Care www.safw.ch

SFFPC La Société Française et Francophone de Plaies et Cicatrisations www.sffpc.org

SWHS Svenskt Sårläkningssällskap www.sarlakning.com

TVS Tissue Viability Society www.tvs.org.uk

WMAOI Wound Management Association of Ireland www.wmaoi.org

WMAS Slovenian Wound Management Association

WMAT Wound Management Association Turkey

EWMA Membership application Surname:

Payment accepted in pound sterling only, drawn on UK bank.

I enclose a cheque of £15. Please indicate cheque no.: Please make cheques payable to: European Wound Management Association

First name(s): Profession: Physician

Surgeon

Dietician

Nurse

Work Address:

Address for Correspondence (if different from above):

Pharmacist

Other

Or: Please debit my account by £15: Credit Card type: (Delta, Master Card or Visa) Credit card no:

Expiry Date: Exact name and initials on the credit card:

Tel:

Please return form and enclose cheque to: EWMA Secretariat, PO Box 864, London SE1 8TT, United Kingdom Tel: +44 207 848 3496, ewma@kcl.ac.uk

Fax: E-mail:

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3 Editorial Carol Dealey

Scientific Articles

4 Wound Healing and Wound Treatment 2004 – the current state Stephan Coerper

10 Vascularized Bone Replacement for the Treatment of Chronic Bone Defects – Initial Results of Microsurgical Solid Matrix Vascularization Ulrich Kneser

16 The Importance of Family and Domiciliary Treatment of Immobile Patients with Chronic Wounds F. Petrella

22 After TIME: wound bed preparation for pressure ulcers Marco Romanelli, Madeleine Flanagan

Background Article

32 Article Review Sue Bale

EBWM

34 Abstracts of Recent Cochrane Reviews Sally Bell-Syer

35 Selected abstracts from 2nd World Union of Wound Healing Societies meeting EWMA

36 EWMA Educational Panel Madeleine Flanagan

37 Call for Registration of all Clinical Trials 40 EWMA Journal Previous Issues 40 International Journals 42 EWMA Author Guidelines 43 EWMA Corporate Sponsor Contact Data Conferences

44 Conference Calendar Organisations

45 PWMA Wound Management in Poland – facing challenges of XXI century Zbigniew Rybak, Wojciech Stras

47 Poland 48 DGfW 49 IWHS Samtök um Sárameðferð Guðbjörg Pálsdóttir

50 Co-operating Organisations