R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, 22 South Greene Street, Baltimore, MD, USA.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Trials. 2022 Sep 12;23(1):772. doi: 10.1186/s13063-022-06541-0.
Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020.
The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites.
The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture.
This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.
大约每 10 例接受手术治疗的开放性骨折患者中，就有 1 例会发生手术部位感染。Aqueous-PREP 试验将研究 10%聚维酮碘与 4%洗必泰在水性抗菌溶液中对减少开放性骨折手术后感染的影响。研究方案于 2020 年 4 月公布。
Aqueous-PREP 试验是一项实用的、多中心、开放性标签、随机多期群组交叉试验。每个参与的群组以 1:1 的比例随机分配，在研究期间为所有符合条件的患者提供 2 种研究干预措施中的 1 种。干预期为 2 个月。完成 2 个月的干预期后，参与的群组交叉到替代干预措施。我们计划在 14 个地点招募至少 1540 名患者。
主要结局是根据疾病预防控制中心国家医疗保健安全网络报告标准（2017 年）指导的手术部位感染。所有参与者的手术部位感染监测期将在确定性骨折管理手术后 30 天结束（对于浅表感染）和 90 天（对于深部切口或器官/空间感染）[1]。次要结局是骨折后 12 个月内计划外与骨折相关的再次手术。
本文档是 Aqueous-PREP 试验的正式统计分析计划（版本 1.0）。统计分析计划于 2022 年 2 月 28 日完成。
