Primary Care Clinical Sciences, University of Birmingham, United Kingdom.
Ann Surg. 2012 Jun;255(6):1017-29. doi: 10.1097/SLA.0b013e31823e7411.
Assess the existing evidence on the clinical effectiveness of wound-edge protection devices (WEPDs) in reducing the surgical site infection (SSI) rate in patients undergoing open abdominal surgery.
Surgical site infections are a common postoperative complication associated with considerable morbidity, extended hospital stay, increased health care costs, and reduced quality of life. Wound-edge protection devices have been used in surgery to reduce SSI rates for more than 40 years; however, they are yet to be cited in major clinical guidelines addressing SSI management.
A review protocol was prespecified. A variety of sources were searched in November 2010 for studies containing primary data on the use of WEPDs in reducing SSI compared with standard care in patients undergoing open abdominal surgery. The outcome of interest was a well-specified, clinically based definition of an SSI. No language or time restrictions were applied. The quality assessment of the studies and the quantitative analyses were performed in line with the principles of the Cochrane Collaboration.
Twelve studies reporting primary data from 1933 patients were included in the review. The quality assessment found all of them to be at considerable risk of bias. An exploratory meta-analysis was performed to provide a quantitative indication on the effect of WEPDs. The pooled risk ratio under a random effects model was 0.60 (95% confidence interval, 0.41-0.86), indicating a potentially significant benefit from the use of WEPDs. No indications of significant between-study heterogeneity or publication bias, respectively, were identified.
Evidence to date suggests that WEPDs may be efficient in reducing SSI rates in patients undergoing open abdominal surgery. However, the poor quality of the existing studies and their small sample sizes raise the need for a large, good quality randomized controlled trial to validate this indication.
评估现有的关于腹壁切开术中使用伤口边缘保护装置（WEPD）降低手术部位感染（SSI）发生率的临床效果的证据。
手术部位感染是一种常见的术后并发症，会导致相当大的发病率、延长住院时间、增加医疗保健成本和降低生活质量。WEPD 已在手术中使用超过 40 年，以降低 SSI 发生率；然而，它们尚未被引用到解决 SSI 管理的主要临床指南中。
预先规定了审查方案。2010 年 11 月，从各种来源搜索了包含 WEPD 与标准护理在接受开放式腹部手术的患者中比较，以降低 SSI 发生率的原始数据的研究。关注的结果是对 SSI 的明确定义、基于临床的定义。没有应用语言或时间限制。研究的质量评估和定量分析符合 Cochrane 协作的原则进行。
综述共纳入了 12 项研究，这些研究报告了 1933 名患者的原始数据。质量评估发现，所有研究都存在相当大的偏倚风险。进行了探索性荟萃分析，以提供 WEPD 效果的定量指示。随机效应模型下的汇总风险比为 0.60（95%置信区间，0.41-0.86），表明 WEPD 的使用可能具有显著的益处。未发现研究间异质性或发表偏倚的迹象。
迄今为止的证据表明，WEPD 可能有助于降低接受开放式腹部手术的患者的 SSI 发生率。然而，现有研究的质量差和样本量小，需要进行一项大型、高质量的随机对照试验来验证这一适应症。
