This protocol describes the Lifebox trial evaluating Clean Cut's ability to reduce infections following cesarean sections in Ethiopia
CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section – CLEAN-CS:
Surgical Site infection (SSI) is a common and devastating complication of surgery, and infection rates are particularly high in low- and middle-income countries (LMICs). Cesarean section (CS) is the most commonly performed major operation in the world and patients are at risk from complications, including SSI.
Lifebox’s Clean Cut program focuses on improving compliance with six critical surgical infection prevention standards to reduce the rate of SSIs. The Clean-CS Trial will study the impact of these six surgical infection prevention standards on patients undergoing CS. Clean-CS is a cluster-randomized stepped wedge interventional study to evaluate this multimodal, adaptive program to reduce surgical infections following cesarean delivery.
Primary Study Objective:
- To reduce postoperative infections in patients undergoing CS
- 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 mortality rates in patients undergoing obstetrical and gynecological operations
To assess facility readiness for and capacities to engage in quality improvement programs in surgery
The impact of the CS-tailored Clean Cut program will be tested through a stepped-wedge trial at 10 hospitals over the course of 24 months. These hospitals will start by collecting compliance information and outcomes on all patients undergoing CS prior to implementation. Over the course of 10 months, two hospitals at a time will begin implementing Clean Cut.
CS is the single most common surgical procedure performed worldwide. In Ethiopia, the majority of operations performed are considered essential surgical procedures, estimates suggest that CS accounts for 30-50% of all operations performed.
The maternal mortality rate in Ethiopia is 401 per 100,000 live births and neonatal mortality 30 per 1,000 live births. 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 12%.
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. In Ethiopia, the national CS rate per live births was 1.9% in 2016, but rates are highly variable by region. Approximately 10.6% of births occur by CS in urban areas, compared to 0.9% of CS births in rural areas. In addition, complications are common, and gynecological and obstetric surgical interventions are associated with high rates of morbidity. Many complications are preventable, and quality improvement efforts are a high priority within the Ethiopian Federal Ministry of Health (FMOH).
Clean Cut engages all members of the surgical team and a hospital’s management to map out surgical safety processes and identify where these can be strengthened to improve adherence to six essential perioperative infection prevention practices:
- Appropriate skin preparation of both the surgeon’s hands and the surgical site with proper antiseptic agents (in cesarean section and other obstetric and gynecologic operations, vaginal cleansing is also performed)
- Maintenance of the sterile field by ensuring the integrity and sterility of surgical gowns, drapes, and gloves
- Proper confirmation of instrument sterility by the operating team
- Appropriate antibiotic administration within one hour prior to surgical incision to optimize prophylaxis
- Complete gauze/swab counts before and after every case
- Use of the WHO Surgical Safety Checklist to promote teamwork, communication, and a culture of safety in the operating room
The results of Clean Cut – published in the British Journal of Surgery – detailed the impact of Clean Cut in five pilot hospitals in Ethiopia. Using the outcomes of over 2,000 surgical patients, the results show a reduction in the risk of SSIs by 35%. Most importantly, for scalability across low- and middle-income countries, Clean Cut requires no major investments in new infrastructure or resources.
“Clean Cut was able to leverage teamwork and multidisciplinary action to dramatically improve compliance with essential perioperative infection prevention standards. This improvement in adherence to such critical standards resulted in profound reductions in postoperative infections. The Grand Challenge Initiative allows for a rigorous study of Clean Cut and its impact on the safety of C-sections.”Dr. Thomas Weiser, Program PI, Consulting Medical Officer of Lifebox and an Associate Professor of Surgery at Stanford University.