聚乳酸基质治疗 Wagner 1 级和 2 级糖尿病足溃疡的疗效:一项单中心、前瞻性随机试验。

Efficacy of a polylactic acid matrix for the closure of Wagner grade 1 and 2 diabetic foot ulcers: a single-center, prospective randomized trial.

机构信息

Surgical Services, Berger Health System, Circleville, OH, United States.

Division of Experimental Surgery, McGill University, Montreal, QC, Canada.

出版信息

Wounds. 2023 Aug;35(8):E257-E260. doi: 10.25270/wnds/23094.

Abstract

INTRODUCTION

CAMPs are used for treating refractory DFUs where other treatments have failed. PLA is a CAMP that has demonstrated effectiveness in promoting healing in burns and acute wounds.

OBJECTIVE

A single-center, prospective, randomized controlled trial comparing PLA-guided closure matrices versus collagen dressings was conducted to assess healing of Wagner grades 1 and 2 DFUs.

MATERIALS AND METHODS

A total of 30 participants were randomized to receive weekly debridement, wound care, and DFU offloading plus either PLA or collagen CAMPs. The primary outcome was the time to achieve full healing, and the secondary outcome was the proportion of ulcers healed at 12 weeks.

RESULTS

The median time to achieve full healing was 9.3 ± 2.9 weeks in the PLA group versus 14.8 ± 8.1 weeks in the collagen group (P = .021), representing a 44% reduction in the time to heal. Furthermore, by 12 weeks, 80% of the PLA-treated ulcers were healed compared to only 33% in the collagen group (P = .025).

CONCLUSION

The results of this study show PLA matrices induce a potent healing response that leads to reduced healing time and an increased OR for achieving healing by 12 weeks.

摘要

简介

CAMPs 用于治疗其他治疗方法失败的难治性 DFUs。PLA 是一种 CAMP,已证明在促进烧伤和急性伤口愈合方面有效。

目的

进行了一项单中心、前瞻性、随机对照试验,比较 PLA 引导的闭合矩阵与胶原蛋白敷料,以评估 Wagner 1 级和 2 级 DFUs 的愈合情况。

材料和方法

共有 30 名参与者随机接受每周清创、伤口护理和 DFU 减压,外加 PLA 或胶原蛋白 CAMPs。主要结果是达到完全愈合的时间,次要结果是 12 周时溃疡愈合的比例。

结果

PLA 组达到完全愈合的中位数时间为 9.3 ± 2.9 周,而胶原蛋白组为 14.8 ± 8.1 周(P =.021),表明愈合时间缩短了 44%。此外,在 12 周时,80%的 PLA 治疗溃疡愈合,而胶原蛋白组仅为 33%(P =.025)。

结论

这项研究的结果表明 PLA 基质诱导出强烈的愈合反应,从而缩短了愈合时间,并增加了在 12 周时达到愈合的 OR。

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