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

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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.

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使用电纺生物纱布是安全的，并且不会减少烧伤创面的皮肤移植：一项随机对照临床试验

分厚自体皮肤移植是烧伤外科治疗的金标准。在临床前研究中，使用SKINHEALTEX PLGA，一种静电纺聚（乳酸-羟基乙酸）酸（PLGA）生物膜，放置在自体移植物和其床之间，显示出刺激皮肤再生，增加移植物吸收和改善疤痕质量的潜力。这些特性尚未在人体临床试验中得到评估。目的：本研究的主要目的是评估SKINHEALTEX PLGA在人体组织（特别是自体裂厚皮肤移植和创面烧伤）上的耐受性和安全性。材料与方法对需要手术治疗的成人深度烧伤患者进行了一项为期4年的双盲随机对照临床试验（2018年11月至2022年9月）。每位患者作为自己的对照，随访12个月。在对照区应用自体皮肤移植物，而在治疗区，在自体移植物和床之间插入SKINHEALTEX PLGA。结果变量为不良事件发生率、移植百分比（临床评估）、温哥华疤痕量表、患者和观察者疤痕评估量表得分。结果26例患者对生物膜的耐受性良好。未观察到与SKINHEALTEX PLGA相关的不良事件。对照组（单独的自体皮片）与自体皮片和SKINHEALTEX PLGA组在自体皮片厚度和随后的疤痕质量方面无统计学差异。结论应用电纺生物材料治疗自体植皮烧伤的临床研究尚属首例。SKINHEALTEX PLGA是一种具有生物相容性和安全性的产品，可以作为自体移植物和烧伤清除床之间的界面，而不会减少移植物的吸收。需要进一步的研究来评估SKINHEALTEX PLGA对烧伤创面的价值，以及它作为一种促进烧伤患者皮肤再生的分子给药途径的潜力。

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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.