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负压伤口疗法在糖尿病足溃疡愈合中的应用:一项前瞻性随机研究。

Expanded negative pressure wound therapy in healing diabetic foot ulcers: a prospective randomised study.

机构信息

Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Miraglia 2, Napoli, Campania, Italy.

出版信息

J Wound Care. 2021 Feb 2;30(2):121-129. doi: 10.12968/jowc.2021.30.2.121.

DOI:10.12968/jowc.2021.30.2.121
PMID:33573486
Abstract

OBJECTIVE

This study aims to evaluate the benefits of treating diabetic foot ulcers (DFU) through a revised procedure using the mechanisms underlying negative pressure wound therapy (NPWT) in such a way as to achieve reduced and more evenly distributed lateral tension lines across the wound.

METHOD

Patients with type 2 diabetes were assessed for elegibility. Included patients were divided randomly into two groups: the NPWT control group and the NPWT+ group. Patients in the NPWT control group were treated in the traditional manner: wounds were covered with foams shaped to fit the wound precisely. In the NPWT+ group, foams were shaped to fit the wound precisely, and an additional foam was then wrapped around the foot.

RESULTS

Some 85 patients were assessed for eligibility; 59 were randomised into two groups: 29 patients in the NPWT+ group and 30 patients in the NPWT group. The primary objective was median healing time (NPWT+ 19 days, interquartile ratio (IQR) 7.5; NPWT 33 days, IQR 16; p<0.00001), and complete wound healing at three weeks (NPWT+ 55.20% NPWT 26.70% p=0.02). Secondary endpoints included number of major amputations (none in either group) and number of infections (NPWT+ 3.44% of patients, NPWT 6.66% of patients; p=0.57).

CONCLUSION

Our initial findings show that this treatment significantly reduced wound closure times and accelerated healing in DFUs. It also demonstrated promising improvements in healing rates, with no significant increase in wound complications.

摘要

目的

本研究旨在评估通过一种改良的程序,利用负压伤口治疗(NPWT)的机制,实现减少和更均匀分布的侧向张力线穿过伤口,从而治疗糖尿病足溃疡(DFU)的益处。

方法

评估 2 型糖尿病患者的入选资格。纳入的患者被随机分为两组:NPWT 对照组和 NPWT+组。NPWT 对照组的患者采用传统方法治疗:用泡沫精确贴合伤口。在 NPWT+组中,泡沫精确贴合伤口,然后在脚周围包裹一层额外的泡沫。

结果

共有 85 名患者接受了资格评估;59 名患者被随机分为两组:NPWT+组 29 名患者和 NPWT 组 30 名患者。主要目的是中位愈合时间(NPWT+19 天,四分位距(IQR)7.5;NPWT 33 天,IQR 16;p<0.00001),以及三周内完全愈合(NPWT+55.20%,NPWT 26.70%,p=0.02)。次要终点包括主要截肢(两组均无)和感染数量(NPWT+3.44%的患者,NPWT 6.66%的患者;p=0.57)。

结论

我们的初步发现表明,这种治疗方法显著缩短了 DFU 的伤口闭合时间,加速了愈合。它还显示出在愈合率方面有很大的改善,而伤口并发症没有显著增加。

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