CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section - CLEAN-CS: A Cluster-Randomized, Stepped Wedge Interventional Trial to Reduce Postoperative Infections Following Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,506
- 试验地点
- 10
- 主要终点
- Surgical infections following cesarean delivery
研究概览
简要总结
Executive summary: Cesarean delivery, or section (CS), is the single most common surgical procedure performed. Estimates indicate that in low resource settings, CS comprises up to 50% of more of the total volume of operations performed. The World Health Organization recommends national CS rates of between 10-15% to save lives and improve maternal and neonatal outcomes. Population-based work indicates that CS rates of up to 19% are demonstrably related to improved maternal and neonatal survival. However, complications are common, and gynecological and obstetric surgical interventions are associated with high rates of morbidity. In low resource settings, complication rates are particularly high.
The intervention being tested is based on a previously developed program called Clean Cut. Clean Cut is an adaptive, multimodal surgical infection prevention program that integrates perioperative process improvement and patient outcomes measurement using process mapping, training and improved management practices, and compliance with critical standards of surgical antisepsis. It was successfully piloted in five surgical departments in Ethiopia, and reduced the relative risk of infection by 35%. This has been adapted specifically for obstetric and gynecological operations and will be evaluated in a cluster randomized stepped wedge trial design in ten maternity hospitals/departments in Ethiopia in order to reduce infections and other complications for women undergoing cesarean delivery and other obstetric and gynecologic operations.
详细描述
Background: Cesarean section (CS) is the single most common surgical procedure performed worldwide. In Ethiopia, estimates suggest that CS accounts for 30-50% of all operations performed. Population-based work indicates that CS rates of up to 19% are demonstrably related to improved maternal and neonatal survival. In Ethiopia, the national CS rate per live births was 1.9% in 2016, but rates are highly variable by region. In addition, complications are common, and gynecological and obstetric surgical interventions are associated with high rates of morbidity. Infections and complications following CS are estimated to cause 15% of maternal deaths in the country, and the overall SSI rate following CS is estimated at 9%. Failure to administer preoperative antibiotics has been highlighted as a particular improvement opportunity, and is one of the critical processes this program will focus on.
Lifebox, a charity devoted to improving surgical and anesthesia safety, developed a program to improve compliance with the WHO Surgical Safety Checklist and improve adherence to critical standards of perioperative infection prevention. This initiative, called Clean Cut, is an adaptive, multimodal surgical infection prevention program that integrates perioperative process improvement and patient outcomes measurement using process mapping, training and improved management practices, and compliance with critical standards of surgical antisepsis. The program was the result of a joint collaboration between the Ethiopian Federal Ministry of Health (FMOH), the Surgical Society of Ethiopia, and Lifebox and resulted in a 35% relative risk reduction in postoperative infections.
Aims -
Primary:
- To reduce postoperative infections in patients undergoing CS Secondary
- To reduce postoperative infections in patients undergoing other obstetrical and gynecological operations
- To improve compliance with a core set of critical perioperative infection prevention and control practices that are essential to reducing infectious risks from surgical intervention
- To reduce the need for reoperation in patients undergoing obstetrical and gynecological operations
- To reduce the length of stay due to infectious and other complications for patients undergoing obstetrical and gynecological operations
- To reduce mortality rates in mothers undergoing CS
- To reduce mortality rates in women undergoing obstetrical and gynecological operations
- To reduce mortality rates in neonates delivered by CS Ancillary
- To assess facility readiness for and capacities to engage in quality improvement programs in surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any patient undergoing obstetric and gynecologic surgery at any time in one of the targeted operating theatres is eligible for inclusion
排除标准
- •there will be no exclusion criteria
结局指标
主要结局
Surgical infections following cesarean delivery
时间窗: 18 months
Number of patients undergoing cesarean delivery diagnosed with postoperative infection in hospital or up to 30 days post surgery; measured by change pre and post intervention
次要结局
- Length of Stay(18 months)
- Compliance with infection prevention practices(18 months)
- Reoperation following obstetric and gynecologic surgery(18 months)
- Postoperative mortality(18 months)
- Surgical infections following obstetric and gynecologic operations(18 months)
- Postoperative maternal mortality(18 months)
- Neonatal mortality(18 months)
研究者
Tom Weiser
Consulting Medical Officer
The Lifebox Foundation