A comparative experimental trial between two artificial skin substitutes: Integra bilayer versus Matriderm 2mm to cover a full-thickness skin wound

Abstract

Background: Artificial Skin Substitutes (ASS) are bioengineered materials designed as acellular scaffolds that act as substrate for cellular growth, proliferation and support for new tissue formation. ASS are indicated as alternatives to wound healing in circumstances when standard therapies are not feasible. ASS are a reality since 1981 and there currently are a huge range of matrix to choose. Integra® has been the first one and the most used worldwide. Nevertheless, there are other ASS with different characteristics than can improve it. Matriderm® 2mm is a new acellular scaffold similar to Integra®, but with a different material composition that allows an earlier cover of the skin loss with a skin autograft. Objective: To compare the clinical outcomes between Matriderm® 2 mm versus Integra® bilayer, as a treatment to cover a full-thickness skin wound, using the clinical scales Vancouver Scar Scale (VSS) and Patient and Observes Scar Assessment Scale (POSAS). Intervention: Both ASS will be performed in two-step grafting procedure. The wound will be covered at first with an ASS and there will be a second stage surgery to graft a split-thickness skin autograft. Methods/Design: It is designed a multicenter, controlled, randomized and single blind trial. 154 patients with full-thickness skin wound that fulfill the inclusion and exclusion criteria will be included