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腹股沟血管外科切口负压伤口治疗的保护作用:一项随机对照试验-INVIPS 试验。

Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: A Randomized Controlled Trial-INVIPS Trial.

机构信息

Vascular Centre, Skane University Hospital, Malmö, Sweden.

Department of Clinical Sciences, Malmö, Lund University, Lund, Sweden.

出版信息

Ann Surg. 2020 Jan;271(1):48-53. doi: 10.1097/SLA.0000000000003364.

DOI:10.1097/SLA.0000000000003364
PMID:31283565
Abstract

OBJECTIVE

A randomized controlled trial (RCT) was undertaken to determine the effect of negative pressure wound therapy (NPWT) on closed incisions after inguinal vascular surgery regarding surgical site infections (SSIs) and other wound complications.

BACKGROUND

SSIs are a major concern in open vascular procedures involving the inguinal region. Prophylactic NPWT on closed incisions has shown promising results, but the quality of evidence can be debated. This study aims to objectively evaluate whether NPWT on sutured inguinal incisions after elective vascular surgery can decrease the incidence of surgical site complications.

METHODS

One hundred thirty-nine patients undergoing elective open vascular surgery with inguinal incisions received either NPWT or a standard dressing. Patients with bilateral incisions randomly received a dressing on one incision and the opposite dressing on the other. The primary endpoints were SSI or other wound complications at 3 months, assessed by wound care experts blinded to the treatment arm and using objective wound assessment criteria (ASEPSIS-score). Statistical analysis was performed on an intention-to-treat basis and obtained P values from analyses in the uni- and bilateral groups were combined to an overall P value using Fisher's method for combining P values.

RESULTS

The incidence of SSI was reduced in the NPWT group compared with the control group [11.9% vs 29.5% in the unilateral group (n = 120), 5.3% vs 26.3% in the bilateral group (n = 19), respectively; combined P = 0.02]. No differences regarding other surgical site complications were observed between the groups.

CONCLUSION

NPWT on closed inguinal vascular surgical incisions in elective patients reduces the incidence of SSI.

摘要

目的

一项随机对照试验(RCT)旨在确定负压伤口治疗(NPWT)对腹股沟血管手术后闭合切口的影响,主要是针对手术部位感染(SSI)和其他伤口并发症。

背景

SSI 是涉及腹股沟区域的开放式血管手术的主要关注点。闭合切口预防性 NPWT 已显示出良好的效果,但证据质量仍存在争议。本研究旨在客观评估择期血管手术后缝合的腹股沟切口 NPWT 是否可以降低手术部位并发症的发生率。

方法

139 例行择期开放式血管手术且有腹股沟切口的患者接受 NPWT 或标准敷料治疗。双侧切口的患者随机接受一侧切口敷料,另一侧切口接受相反的敷料。主要终点是 3 个月时的 SSI 或其他伤口并发症,由对治疗分组不知情的伤口护理专家根据客观伤口评估标准(ASEPSIS 评分)进行评估。统计分析基于意向治疗进行,单侧组(n=120)和双侧组(n=19)中分析获得的 P 值采用 Fisher 方法进行合并,得出总体 P 值。

结果

与对照组相比,NPWT 组的 SSI 发生率降低[单侧组分别为 11.9%(n=120)和 29.5%(n=120),双侧组分别为 5.3%(n=19)和 26.3%(n=19);合并 P=0.02]。两组之间其他手术部位并发症的发生率没有差异。

结论

NPWT 应用于择期患者的腹股沟血管外科闭合切口可降低 SSI 的发生率。

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