Trials. 2022 Mar 9;23(1):204. doi: 10.1186/s13063-022-06102-5.
Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems around the world. The aim of this trial is to assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated, or dirty abdominal surgery.
This study protocol describes a pragmatic, international, multi-centre, 2-arm, cluster randomised controlled trial, with an internal pilot. Clusters are defined as hospitals within low- and middle-income countries (LMICs) defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list, where there are at least 4 eligible hospitals per country. Hospitals (clusters) must be in LMICs where glove and instrument change are not currently routine practice. Patients (adults and children) undergoing emergency or elective abdominal surgery for a clean-contaminated, contaminated, or dirty operation are eligible for inclusion. Before closing the abdominal wall, surgeons and the scrub nurse will change gloves and use separate, sterile instruments (intervention), versus no changing gloves or using separate, sterile instruments (standard practice, control). The primary outcome is SSI within 30 days after surgery, using the Centre for Disease Control (CDC) criteria. Secondary outcomes are SSI before point of hospital discharge, and readmission, reoperation, length of hospital stay, return to normal activities, and death up to 30-days after surgery. A 12-month internal pilot, including 12 clusters and approximately 600 participants, aims to assess adherence to allocation and follow-up of patients. The main trial is powered to detect a minimum reduction in the primary outcome from 16 to 12%. A total of 12,800 participants will be recruited from 64 clusters (hospitals) each including at least 200 participants.
Change of gloves and sterile instruments prior to fascial closure in abdominal surgery is a low-cost, simple, intraoperative intervention which involves all members of the surgical and scrub team. If effective at reducing SSI, this practice could be readily implemented across all contexts. The findings of this trial will inform future guideline updates from international healthcare organisations, including the World Health Organization.
ClinicalTrials.gov NCT03980652. Registered on 9 July 2019.
手术部位感染（SSI）是全世界患者、医生和医疗体系的主要负担。本试验旨在评估与当前常规医院实践相比，在手术结束时使用单独的无菌手套和器械来缝合伤口是否可以降低清洁污染、污染或污染手术患者术后 30 天的手术部位感染率。
本研究方案描述了一项实用的、国际性的、多中心的、2 臂、集群随机对照试验，内部有一个试验。集群定义为按发展援助委员会（DAC）官方发展援助（ODA）名单确定的低收入和中等收入国家（LMICs）内的医院，每个国家至少有 4 家符合条件的医院。医院（集群）必须位于 LMICs 中，手套和器械更换目前不是常规做法。接受清洁污染、污染或污染手术的急诊或择期腹部手术的患者（成人和儿童）符合纳入标准。在关闭腹壁之前，外科医生和洗手护士将更换手套并使用单独的无菌器械（干预组），而不是不更换手套或使用单独的无菌器械（标准组，对照组）。主要结局是术后 30 天内使用疾病控制与预防中心（CDC）标准的手术部位感染。次要结局是出院前的手术部位感染，以及再入院、再次手术、住院时间、恢复正常活动和术后 30 天内的死亡。为期 12 个月的内部试验包括 12 个集群和大约 600 名参与者，旨在评估患者的分配和随访情况。主要试验的目的是检测从 16%降低到 12%的主要结局的最小降低。将从每个包括至少 200 名参与者的 64 个集群（医院）招募 12800 名参与者。
在腹部手术中缝合筋膜前更换手套和无菌器械是一种低成本、简单的术中干预措施，涉及手术和洗手团队的所有成员。如果能有效降低 SSI，这种做法可以在所有情况下迅速实施。该试验的结果将为世界卫生组织等国际卫生保健组织的未来指南更新提供信息。
ClinicalTrials.gov NCT03980652。于 2019 年 7 月 9 日注册。
