Glyaderm(®) dermal substitute: clinical application and long-term results in 55 patients.

Abstract

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. 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. 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. 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(®).