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Improvement of Periulcer Skin Condition in Venous Leg Ulcer Patients: Prospective, Randomized, Controlled, Single-blinded Clinical Trial Comparing a Biosynthetic Cellulose Dressing with a Foam Dressing

Dini, Valentina MD; Romanelli, Marco MD, PhD; Andriessen, Anneke PhD, PA; Barbanera, Sabrina MD; Bertone, Maria Stefania NT; Brilli, Cinzia RN; Abel, Martin PhD

Advances in Skin & Wound Care:
doi: 10.1097/01.ASW.0000431237.22658.15
Features: Original Investigations

OBJECTIVES: The aim of this study was to investigate the influence of a biosynthetic cellulose wound dressing (BWD) to stimulate wound healing in patients with a venous leg ulcer on periulcer skin condition when compared with standard care using a foam dressing.

METHODS: Each patient with a venous ulcer received compression therapy with a short stretch bandage system and either a BWD + foam (study group [SG]) or foam (control group [CG]). Periulcer skin condition was compared with the untreated lower leg skin and the forearm skin, using noninvasive parameters, comparing day 0 versus day 28 results. Ulcers were further evaluated for healing rate. The study period was 28 days, and the follow-up period was 12 weeks. Fifty patients were recruited to the study, of which N = 46 (SG, n = 26; CG, n = 20) completed the 28-day study period and were included in the analysis.

RESULTS: The BWD showed a more improved periulcer skin condition versus the CG. Transepidermal water loss was significantly less in the SG (P = .003), as well as the results shown with the chromatometer (P =. 05). Ulcer healing rate was also statistically significant in favor of the SG (P = .0001).

CONCLUSION: Treatment for the BWD + foam group was shown to be safe and significantly improved periwound skin condition, leading to more expeditious wound healing than treatment with foam alone.

In Brief

In this investigation, the influence of a biocellulose wound dressing to stimulate wound healing in patients with venous leg ulcers on periulcer skin condition when compared with standard care using a foam dressing is assessed.

Author Information

Valentina Dini, MD, is a Consultant Dermatologist, Wound Healing Research Unit, and Marco Romanelli, MD, PhD, is Assistant Professor, both in the Department of Dermatology, University of Pisa, Pisa, Italy. Anneke Andriessen, PhD, PA, is Director, Andriessen Consultants Malden and UMC St Radboud, Nijmegen, the Netherlands. Sabrina Barbanera, MD, is a Consultant Dermatologist; Maria Stefania Bertone, NT, is a Nutritionist; and Cinzia Brilli, RN, is a Consultant Dermatology Nurse, all in the Wound Healing Research Unit, Department of Dermatology, University of Pisa, Pisa, Italy. Martin Abel, PhD, is Head of Medical & Regulatory Affairs, Lohmann & Rauscher GmbH & Co KG, Rengsdorf, Germany. Drs Dini, Romanello, Andriessen, and Barbanera and Mss Bertone and Brilli have disclosed they have no financial relationships related to this article. Dr Abel has disclosed that he is an employee of Lohmann & Rauscher GmbH & Co KG.

Acknowledgment: This study was supported by Lohmann & Rauscher GmbH. Submitted November 7, 2011; accepted in revised form March 1, 2012.

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