A Novel Epidermal Growth FactorYContaining Wound Dressing for the Treatment of Hard-to-Heal Venous Leg Ulcers Martin Doerler, MD; Sabine Eming, MD; Joachim Dissemond, MD; Anneke Wolter, MD; Maren Stoffels-Weindorf, MD; Stefanie Reich-Schupke, MD; Peter Altmeyer, MD; and Markus Stu ¨ cker, MD ABSTRACT OBJECTIVE: To evaluate the efficacy, tolerability, and safety of a novel wound dressing containing epidermal growth factor (EGF) in a collagen-gel matrix on hard-to-heal venous leg ulcers. PATIENTS AND METHODS: The authors included 33 hard-to-heal venous leg ulcers found on 31 patients. The EGF-containing dressing was applied 3 times while best practice conservative wound treatment was continued. Patients were followed up with after 1, 2, and 3 months to evaluate (a) the wound size, (b) the ease of application and dissolution of the dressing, and (c) the wound dressing by means of a scale ranging from 1 to 5 (1 = best, 5 = worst). RESULTS: The protocol was completed by 25 of 31 patients. The reasons for discontinuation were wound infection, pain, and lost to follow-up (n = 2 each, respectively). After 3 months, the average wound surface was significantly reduced (from 33.69 cm 2 to 18.94 cm 2 , P = .023). On a scale from 0 to 100, the wound dressing was evaluated as very easy to apply and highly dissolvable (mean value of 97.14 and 98.11, respectively; 100 = very easy to apply or 100% dissolution). The dressing was generally well tolerated and scored a mean overall rating of 2.16 by healthcare specialists and 2.40 by patients. CONCLUSION: The authors’ results demonstrate that the novel EGF-containing wound dressing was generally well tolerated and safe. Combined with the significant wound surface reduction, it can be regarded as an adequate novel treatment option for patients with hard-to-heal venous leg ulcers. KEYWORDS: epidermal growth factor, leg ulcers, wound dressings, hard-to-heal wounds ADV SKIN WOUND CARE 2014;27:456Y60 INTRODUCTION Considering that hard-to-heal chronic leg ulcers cause consider- able healthcare expenses, there is an urgent need for efficient and evidence-based treatment options. 1 In venous leg ulcers, improved healing and lower recurrence rates could be demonstrated for su- perficial venous surgery, endovenous laser therapy, and compres- sion therapy. 2Y7 In addition, certain debridement techniques show improved healing outcomes. 8 Patients with hard-to-heal leg ulcers commonly have medical conditions that limit the therapeutic options for conservative strate- gies. However, in contrast to the benefit of compression therapy, multiple randomized controlled trials comparing different wound dressings could not prove a significant impact on the healing of venous leg ulcers. 9 With regard to epidermal growth factor (EGF) treatment for ve- nous leg ulcers, previous studies showed divergent effects. For topical EGF, a greater reduction of the wound size and more healed ulcers were reported compared with the placebo. 10 Studies investi- gating topical transforming growth factor A2 and repifermin (recom- binant human keratinocyte growth factor 2) concluded a potential positive effect on the closure of venous leg ulcers. 11,12 A current systematic Cochrane review found no evidence for improved heal- ing of chronic wounds with autologous platelet-rich plasma, which contains high concentrations of growth factors. 13 The objective of the authors’ prospective, noncomparative study was to investigate the effect of a novel wound dressing containing EGF in a collagen-gel matrix (Neoderm; Ars Arthro, Ankara, Turkey) for the treatment of hard-to-heal chronic venous leg ulcers. METHODS The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the responsible ethics committee (vote no. 11-265). This study included 31 pa- tients with 33 hard-to-heal chronic venous leg ulcers enrolled from 3 specialized German wound centers. All patients with ulcers not ADVANCES IN SKIN & WOUND CARE & VOL. 27 NO. 10 456 WWW.WOUNDCAREJOURNAL.COM ORIGINAL INVESTIGATION Martin Doerler, MD, is a Dermatology Consultant at the Vein Center, Departments of Dermatology and Vascular Surgery, at Ruhr-University Bochum, Germany. Sabine Eming, MD, is a Professor in the Department of Dermatology at the University of Cologne, Germany. Joachim Dissemond, MD, is a Professor in the Department of Dermatology at the University of Essen, Germany. Anneke Wolter, MD, is a Resident in the Department of Dermatology at the University of Cologne, Germany. Maren Stoffels-Weindorf, MD, is a Resident in the Department of Dermatology at the University of Essen, Germany. Stefanie Reich-Schupke, MD, is the Department Head of the Competence Center for Phlebology and Dermatology, Artemed-Fachklinik Prof. Dr. Dr. Salfeld GmbH & Co. KG, Bad Oeynhausen, Germany. Peter Altmeyer, MD, is the Chief Physician and Professor of Dermatology in the Department of Dermatology, Venereology, and Allergology at Ruhr-University Bochum, Germany. Markus Stu ¨ cker, MD, is a Professor at the Vein Center in the Departments of Dermatology and Vascular Surgery at Ruhr-University Bochum, Germany. Acknowledgments: The authors have disclosed that this study was funded by Globalvision Medical GmbH (Bad Honnef, Germany) and that they have no personal financial relationships related to this article. The sponsor had no role in patient recruitment, data analysis and interpretation, or the preparation of the manuscript. Submitted July 23, 2013; accepted in revised form February 24, 2014. Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. 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