Ali Pirayesh1, Henk Hoeksema1, Cornelia Richters2, Jozef Verbelen1, Stan Monstrey3. 1. Department of Plastic and Reconstructive Surgery, Burn Center, Ghent University Hospital, Ghent, Belgium. 2. Department of Molecular Cell Biology and Immunology, Medical Faculty, Vrije Universiteit Medical Center, Amsterdam, The Netherlands; Euro Skin Bank, Beverwijk, The Netherlands. 3. Department of Plastic and Reconstructive Surgery, Burn Center, Ghent University Hospital, Ghent, Belgium. Electronic address: Stan.Monstrey@UGent.be.
Abstract
INTRODUCTION:Glycerol preserved acellular dermis (Glyaderm(®)) consists of collagen and elastin fibers and is the first non-profit dermal substitute derived from glycerol-preserved, human allogeneic skin. It is indicated for bi-layered skin reconstruction of full thickness wounds. METHODS: A protocol for clinical application and optimal interval before autografting with split thickness skin graft (STSG) was developed in a pilot study. A phase III randomized, controlled, paired, intra-individual study compared full thickness defects engrafted with Glyaderm(®) and STSG versus STSG alone. Outcome measures included percentage of Glyaderm(®) take, STSG take, and scar quality assessment. RESULTS:Pilot study (27 patients): Mean take rates equaled 91.55% for Glyaderm(®) and 96.67% for STSG. The optimal autografting interval was 6 days (±1 day). Randomized trial (28 patients): Mean Glyaderm(®) take rate was 88.17%. STSG take rates were comparable for both research groups (p=0.588). One year after wound closure, Glyaderm(®)+STSG was significantly more elastic (p=0.003) than STSG alone. Blinded observers scored Glyaderm(®) treated wounds better in terms of scar quality. DISCUSSION: The efficacy of Glyaderm(®) as a suitable dermal substitute for full thickness wounds is attested. Currently a procedure for simultaneous application of Glyaderm(®) and STSG is adopted, allowing for further widespread use of Glyaderm(®).
RCT Entities:
INTRODUCTION:Glycerol preserved acellular dermis (Glyaderm(®)) consists of collagen and elastin fibers and is the first non-profit dermal substitute derived from glycerol-preserved, human allogeneic skin. It is indicated for bi-layered skin reconstruction of full thickness wounds. METHODS: A protocol for clinical application and optimal interval before autografting with split thickness skin graft (STSG) was developed in a pilot study. A phase III randomized, controlled, paired, intra-individual study compared full thickness defects engrafted with Glyaderm(®) and STSG versus STSG alone. Outcome measures included percentage of Glyaderm(®) take, STSG take, and scar quality assessment. RESULTS: Pilot study (27 patients): Mean take rates equaled 91.55% for Glyaderm(®) and 96.67% for STSG. The optimal autografting interval was 6 days (±1 day). Randomized trial (28 patients): Mean Glyaderm(®) take rate was 88.17%. STSG take rates were comparable for both research groups (p=0.588). One year after wound closure, Glyaderm(®)+STSG was significantly more elastic (p=0.003) than STSG alone. Blinded observers scored Glyaderm(®) treated wounds better in terms of scar quality. DISCUSSION: The efficacy of Glyaderm(®) as a suitable dermal substitute for full thickness wounds is attested. Currently a procedure for simultaneous application of Glyaderm(®) and STSG is adopted, allowing for further widespread use of Glyaderm(®).
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Authors: Corien Oostendorp; Peter J E Uijtdewilligen; Elly M Versteeg; Theo G Hafmans; Ellen H van den Bogaard; Paul K J D de Jonge; Ali Pirayesh; Johannes W Von den Hoff; Ernst Reichmann; Willeke F Daamen; Toin H van Kuppevelt Journal: Sci Rep Date: 2016-01-07 Impact factor: 4.379