Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial
Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial
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DOI：
10.1111/codi.15354
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发表时间：
2020-10-05
影响因子：
3.4
通讯作者：
Bhangu, A.
中科院分区：
文献类型：
--
作者：
Nepogodiev, D.;Bhangu, A.
手术部位感染（SSI）是世界范围内最常见的术后并发症，是患者和卫生系统的主要负担。SSI的发生率在低收入和中等收入国家（LMICs）中明显较高，但几乎没有高质量的证据表明干预措施可以预防LMICs中的SSI。方法：RISKCON是一项实用的、多中心、2 x 2析因、分层随机对照试验，具有内部可行性研究，将解决对降低LMIC患者接受腹部手术的SSI发生率的措施的证据需求。评估（1）2%酒精洗必泰与10%聚维酮碘用于皮肤准备，或（2）三氯生涂层缝线与无涂层缝线用于筋膜闭合，是否可以减少（1）清洁-污染和（2）污染/脏污手术后30天的手术部位感染。腹部皮肤切口>= 5 cm的预期清洁-污染或污染/脏污伤口的患者将以1：1：1：1的比例随机分配至（1）2%酒精洗必泰和无涂层缝线、（2）2%酒精洗必泰和三氯生涂层缝线、（3）10%聚维酮碘水溶液和无涂层缝线和（4）10%聚维酮碘水溶液和三氯生涂层缝线。两个层（清洁-污染与污染/肮脏伤口）分别供电。总的来说，ESTCON的目标是招募5480名患者。根据疾病控制中心对SSI的定义，主要结局是30天时的SSI。结论ESTCON将提供高质量的证据，在一系列LMIC设置中是可推广的。它将影响国际临床指南的修订，确保其研究结果在全球传播。
Aim Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs. Method FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (1) clean-contaminated and (2) contaminated/dirty surgery. Patients with predicted clean-contaminated or contaminated/dirty wounds with abdominal skin incision >= 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and noncoated suture and (4) 10% aqueous povidone-iodine and triclosan-coated suture. The two strata (clean-contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI. Conclusion FALCON will deliver high-quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.