Clean-CS: A Program to Improve the Safety of C-section

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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 neo...

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 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 postoperative infections in patients undergoing CS Secondary To reduce postoperative infections in patients undergoing other obstetrical and gynecological operations To reduce the need for reoperation in patients undergoing obstetrical and gynecological operations To reduce mortality rates in patients undergoing obstetrical and gynecological operations Ancillary To assess facility readiness for and capacities to engage in quality improvement programs in surgery Participants: Any patient undergoing obstetric and gynecologic surgery at any time in one of the targeted operating theatres is eligible for inclusion; there will be no exclusion criteria. The Intervention: Clean Cut focuses on improving compliance with six critical perioperative infection prevention standards: appropriate skin preparation of the surgeon's hands and the surgical site maintenance of the sterile field by ensuring the integrity and sterility of surgical gowns, drapes, and gloves confirmation of instrument sterility appropriate antibiotic administration complete swab counts routine use of the WHO Surgical Safety Checklist Clean Cut is implemented in five phases: Identification of a Clean Cut team to include members from all perioperative disciplines: Ob/Gyn, surgery, nursing, anesthesia, QI personnel and operating room (OR) management; Establishment of a baseline by conducting context assessments and process mapping the six perioperative standards, and establishing a data collection system; Modification and implementation of the WHO Surgical Safety Checklist to fit local practices; Ongoing data feedback to connect baseline data with process maps, coupled with site-specific action plans for improvement; Targeted training, workshops, and refresher courses using local providers, coupled with a transition to hospital management for sustaining the program. Clean Cut has been adapted specifically for obstetric and gynecological operations and will implement it 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. Clean Cut has been designed with sustainability at its core - the strategy emphasizes teamwork and collective leadership to identify and address critical gaps in perioperative safety processes. Study Design: The impact of the CS-tailored Clean Cut program will be tested through a cluster randomized stepped-wedge study design at 10 hospitals over the course of 24 months. Each selected hospital will be distributed into two groups based on the type of facility: university teaching and referral hospitals in one group, and regional, district, and community hospitals in another. Five clusters and their order will be randomly established, paring a teaching/referral hospital with a regional/district/community hospital. These hospitals will start by collecting inpatient and outpatient outcomes on all patients undergoing CS prior to implementation. Over the course of 10 months, 2 hospitals at a time will begin implementing Clean Cut at 2-month intervals. Each starts by assembling a multidisciplinary improvement team, undergoing team training on WHO Surgical Safety Checklist use and implementation, and gathering compliance information about intraoperative safety practices. The initiation of Clean Cut will also involve creating facility-specific process maps of each critical perioperative practice. Once these process maps and compliance data are complete, usually after 2-4 weeks, the team establishes an adaptive, facility-driven improvement plan based on process gaps and barriers to best practice. Risks, benefits, and IRB review: The protocol has been approved by the Armauer Hansen Research Institute (AHRI/ ALERT) Ethics Review Committee, which is one of the accredited ethical boards at a national level, and is now under review by the national committee. As the standards being implemented are not in dispute and are considered critical for ensuring antisepsis and sterility, patient informed consent will not be obtained and waiver for informed consent has been requested. The Investigator will ensure that this trial is conducted in accordance with relevant regulations and with Good Clinical Practice. Patient data will be kept confidential throughout the study and stored on encrypted servers and password-protected devices. The benefits of this study are improvements in compliance with best practices in perioperative infection prevention. There are no known risks other than those typically associated with surgery that are not specific to this trial. Institutional oversight: Lifebox and the Ethiopian Society of Obstetricians and Gynecologists are jointly organizing and running this study. Lifebox will be responsible for data security and analysis. The ten hospitals are listed in this protocol. Funding: UBS Optimus Foundation through a Gates Grand Challenge Grant Study Contact: Thomas Weiser MD MPH Associate Professor of Surgery, Stanford University Consulting Medical Officer, Lifebox

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