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

IF 3.2 3区医学 Q2 CRITICAL CARE MEDICINE

Burns Pub Date : 2025-02-18 DOI:10.1016/j.burns.2025.107427

María Dolores Pérez-Del-Caz , Nieves Vanaclocha , Pilar Sepúlveda Sanchis , María Blanes , Bruno Marco , Rafael Botella Estrada , Eduardo García-Granero Ximénez , Luís Sabater Ortí , Aranzazu Pérez-Plaza

{"title":"Use of an electrospun bioveil is safe and does not decrease skin graft take on burn wounds: A randomised, controlled clinical trial","authors":"María Dolores Pérez-Del-Caz , Nieves Vanaclocha , Pilar Sepúlveda Sanchis , María Blanes , Bruno Marco , Rafael Botella Estrada , Eduardo García-Granero Ximénez , Luís Sabater Ortí , Aranzazu Pérez-Plaza","doi":"10.1016/j.burns.2025.107427","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Materials and methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":50717,"journal":{"name":"Burns","volume":"51 4","pages":"Article 107427"},"PeriodicalIF":3.2000,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Burns","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0305417925000567","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction

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.

Objective

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.

Materials and methods

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.

Results

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.

Conclusion

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.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Burns 医学-皮肤病学

CiteScore

4.50

自引率

18.50%

发文量

304

审稿时长

72 days

期刊介绍： Burns aims to foster the exchange of information among all engaged in preventing and treating the effects of burns. The journal focuses on clinical, scientific and social aspects of these injuries and covers the prevention of the injury, the epidemiology of such injuries and all aspects of treatment including development of new techniques and technologies and verification of existing ones. Regular features include clinical and scientific papers, state of the art reviews and descriptions of burn-care in practice. Topics covered by Burns include: the effects of smoke on man and animals, their tissues and cells; the responses to and treatment of patients and animals with chemical injuries to the skin; the biological and clinical effects of cold injuries; surgical techniques which are, or may be relevant to the treatment of burned patients during the acute or reconstructive phase following injury; well controlled laboratory studies of the effectiveness of anti-microbial agents on infection and new materials on scarring and healing; inflammatory responses to injury, effectiveness of related agents and other compounds used to modify the physiological and cellular responses to the injury; experimental studies of burns and the outcome of burn wound healing; regenerative medicine concerning the skin.