Use of an electrospun bioveil is safe and does not decrease skin graft take on burn wounds: A randomised, controlled...

Split-thickness skin autografts are the gold standard for surgical treatment of burns. In preclinical studies, the use of SKINHEALTEX PLGA, an electrospun poly(lactic-co-glycolide) acid (PLGA) bioveil, placed between autografts and their bed has shown potential to stimulate dermal regeneration, increase graft take and improve scar quality. These properties have not yet been evaluated in human clinical trials.

The primary goal of this study was to evaluate tolerability and safety of SKINHEALTEX PLGA on human tissues, specifically, split-thickness skin autografts and wound beds of debrided burns.

A double-blind randomised controlled clinical trial was conducted with adult patients with deep burns requiring surgical treatment, for 4 years (November 2018 to September 2022). Each patient acted as their own control, and they were followed for 12 months. In the control area a skin autograft was applied, while in the treatment area SKINHEALTEX PLGA was interposed between the autograft and the bed. The outcome variables were incidence of adverse events, the percentage of graft take (evaluated clinically), and Vancouver Scar Scale and Patient and Observer Scar Assesment Scale scores.

The bioveil was well tolerated in the 26 patients that were recruited. No adverse events related to SKINHEALTEX PLGA were observed. No statistically significant differences were observed in split-thickness skin autograft take and subsequent scar quality between the control group (split-thickness skin autografts alone) and the autograft and SKINHEALTEX PLGA group.

This is the first clinical trial investigating the application of an electrospun biomaterial in the treatment of burns using skin autografts. SKINHEALTEX PLGA is a biocompatible and safe product that can be applied as an interface between autografts and the debrided bed of a burn without reducing graft take. Further research is needed to assess the value of SKINHEALTEX PLGA for burn wounds and its potential as an administration route of molecules than enhance dermal regeneration in burn patients.