ImportanceSurgical site infections (SSIs) are prevalent hospital-acquired infections with significant patient impacts and global health care burdens. The World Health Organization recommends using wound protector devices in abdominal surgery as a preventive measure to lower the risk of SSIs despite limited evidence.ObjectiveTo examine the efficacy of a dual-ring, plastic wound protector in lowering the SSI rate in open gastrointestinal (GI) surgery irrespective of intra-abdominal contamination levels.Design, Setting, and ParticipantsThis multicenter, patient-blinded, parallel-arm randomized clinical trial was conducted from August 2017 to October 2022 at 13 hospitals in an academic setting. Patients undergoing open abdominal bowel surgery (eg, for bowel perforation) were eligible for inclusion.InterventionPatients were randomized 1:1 to a dual-ring, plastic wound protector to protect the incision site of the abdominal wall (experimental group) or a conventional surgical gauze (control group).Main Outcomes and MeasuresThe primary end point was the rate of SSI within 30 days of open GI surgery.ResultsA total of 458 patients were randomized; after 1 was excluded from the control group, 457 were included in the intention-to-treat analysis (mean [SD] age, 58.4 [12.1] years; 256 [56.0%] male; 341 [74.6%] with a clean-contaminated wound): 229 in the wound protector group and 228 in the surgical gauze group. The overall SSI rate in the intention-to-treat analysis was 15.7% (72 of 458 patients). The SSI rate for the wound protector was 10.9% (25 of 229 patients) compared with 20.5% (47 of 229 patients) with surgical gauze. The wound protector significantly reduced the risk of SSI, with a relative risk reduction (RRR) of 46.81% (95% CI, 16.64%-66.06%). The wound protector significantly decreased the SSI rate for clean-contaminated wounds (RRR, 43.75%; 95% CI, 3.75%-67.13%), particularly for superficial SSIs (RRR, 42.50%; 95% CI, 7.16%-64.39%). Length of hospital stay was similar in both groups (mean [SD], 15.2 [10.5] vs 15.3 [10.2] days), as were the overall postoperative complication rates (20.1% vs 18.8%).Conclusions and RelevanceThis randomized clinical trial found a significant reduction in SSI rates when a plastic wound protector was used during open GI surgery compared with surgical gaze, supporting the World Health Organization recommendation for use of wound protector devices in abdominal surgery.Trial RegistrationClinicalTrials.gov Identifier: NCT03170843

中文翻译：

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塑料伤口保护器与手术纱布在减少开放式胃肠道手术中手术部位感染方面的比较

重要性手术部位感染 (SSI) 是常见的医院获得性感染，对患者产生重大影响并给全球医疗保健带来负担。尽管证据有限，世界卫生组织仍然建议在腹部手术中使用伤口保护装置作为预防措施，以降低 SSI 的风险。目的探讨双环塑料伤口保护装置在降低开放式胃肠道 (GI) 中 SSI 发生率方面的功效无论腹内污染程度如何，都可以进行手术。 设计、设置和参与者这项多中心、患者盲法、平行臂随机临床试验于 2017 年 8 月至 2022 年 10 月在 13 家医院的学术环境中进行。接受开腹肠手术（例如肠穿孔）的患者符合纳入条件。 干预 患者按 1:1 的比例随机分配至双环塑料伤口保护器以保护腹壁切口部位（实验组）或传统手术组主要终点是开放式胃肠道手术后30天内SSI的发生率。结果共有458例患者被随机分组​​；从对照组中排除 1 名后，457 名患者被纳入意向治疗分析（平均 [SD] 年龄，58.4 [12.1] 岁；256 名 [56.0%] 名男性；341 名 [74.6%] 名清洁污染患者伤口）：伤口保护器组 229 例，手术纱布组 228 例。意向治疗分析中的总体 SSI 率为 15.7%（458 名患者中的 72 名）。伤口保护器的 SSI 率为 10.9%（229 名患者中的 25 名），而手术纱布的 SSI 率为 20.5%（229 名患者中的 47 名）。伤口保护器显着降低了 SSI 风险，相对风险降低 (RRR) 为 46.81%（95% CI，16.64%-66.06%）。伤口保护器显着降低了清洁污染伤口的 SSI 率（RRR，43.75%；95% CI，3.75%-67.13%），特别是浅表 SSI（RRR，42.50%；95% CI，7.16%-64.39%） 。两组的住院时间相似（平均 [SD]，15.2 [10.5] 天 vs 15.3 [10.2] 天），总体术后并发症发生率也相似（20.1% vs 18.8%）。结论和相关性这项随机临床试验发现与手术凝视相比，在开放式胃肠道手术中使用塑料伤口保护器时，SSI 发生率显着降低，支持世界卫生组织关于在腹部手术中使用伤口保护器装置的建议。试验注册ClinicalTrials.gov 标识符：NCT03170843