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一项比较二烷基碳化氯涂层敷料与标准护理用于预防手术部位感染的初步可行性随机临床试验。

A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection.

机构信息

Academic Vascular Surgical Unit, Hull Royal Infirmary, Hull, UK.

出版信息

Int Wound J. 2019 Aug;16(4):883-890. doi: 10.1111/iwj.13113. Epub 2019 Mar 14.

Abstract

A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)-impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean-contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC-coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC-coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large-scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full-scale RCT.

摘要

手术部位感染 (SSI) 可能发生在高达 30%的手术中,并导致显著的发病率和死亡率。我们旨在评估进行一项随机对照试验 (RCT) 的可行性,该试验旨在研究使用二烷基碳酰氯 (DACC) 浸渍敷料,该敷料在伤口床上结合细菌,以预防原发性闭合切口伤口的 SSI。这项先导 RCT 招募了接受清洁或清洁污染的血管手术的患者。参与者在手术中按 1:1 的比例随机分为 DACC 涂层敷料或对照敷料组。结果分为可行性和临床结果。主要临床结果是 30 天的 SSI(使用疾病控制中心标准和额外治疗、浆液性排出物、红斑、脓性渗出物、深部组织分离、细菌分离和住院时间评分方法评估)。该研究在 12 个月内招募了 144 名患者,中位数为每月 10 名。合格人数占 73%,招募人数占 60%。在 30 天,DACC 涂层组的相对风险降低了 36.9%(16.22%比 25.71%,优势比 0.559,P=0.161)。需要治疗的人数为 11 名患者。鉴于本研究显示的相对风险降低,进行一项大型 RCT 是可行且理想的。需要进一步工作来改进研究方案并让更多中心参与全面的 RCT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34a6/7948922/19a5472c639c/IWJ-16-883-g001.jpg

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