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

Burns. 2015 Feb;41(1):132-44. doi: 10.1016/j.burns.2014.05.013. Epub 2014 Jun 16.

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(®).

Keywords: Acellular dermal matrix; Dermal substitute; Full thickness burn; Glyaderm(®); Skin substitute.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Acellular Dermis*
  • Adolescent
  • Adult
  • Aged
  • Burns / pathology
  • Burns / surgery*
  • Child
  • Child, Preschool
  • Cicatrix
  • Elasticity
  • Humans
  • Infant
  • Laser-Doppler Flowmetry
  • Middle Aged
  • Pilot Projects
  • Skin / blood supply
  • Skin / pathology*
  • Skin Transplantation*
  • Treatment Outcome
  • Wound Healing*
  • Young Adult