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

Area of Science:

• Biomaterials Science
• Regenerative Medicine
• Burn Surgery

Background:

• Split-thickness skin autografts are the standard surgical treatment for burns.
• Electrospun poly(lactic-co-glycolic) acid (PLGA) bioveil (SKINHEALTEX PLGA) showed preclinical promise for dermal regeneration and improved graft outcomes.
• Clinical data on SKINHEALTEX PLGA for burn treatment was previously unavailable.

Purpose of the Study:

• To evaluate the tolerability and safety of SKINHEALTEX PLGA.
• To assess the impact of SKINHEALTEX PLGA on split-thickness skin autografts and debrided burn wound beds in humans.

Main Methods:

• A 4-year, double-blind, randomized controlled clinical trial involving adult burn patients.
• Each patient served as their own control, comparing autograft alone versus autograft with interposed SKINHEALTEX PLGA.
• Outcomes measured included adverse events, clinical graft take percentage, and scar quality via Vancouver Scar Scale and Patient and Observer Scar Assesment Scale.

Main Results:

• The bioveil was well-tolerated by 26 recruited patients, with no observed adverse events related to SKINHEALTEX PLGA.
• No statistically significant differences were found in split-thickness skin autograft take between the control and treatment groups.
• Scar quality, assessed by standardized scales, showed no significant differences between the groups.

Conclusions:

• This first-in-human clinical trial confirms SKINHEALTEX PLGA is a biocompatible and safe interface material for skin autografts in burn treatment.
• SKINHEALTEX PLGA can be applied without compromising graft take or initial scar quality.
• Further research is warranted to explore its therapeutic potential and use as a drug delivery system for enhanced dermal regeneration in burn patients.