Infection Prevention for "Bellwether" Surgery in Ethiopia
Starting soon
Conditions studied: Ceserean Section, Lower Limb Fractures, Surgical Site Infection (SSI)
In brief
The study examines surgical site infections and antimicrobial resistance following life-saving surgeries like C-sections and leg fracture repairs in Ethiopia. It does not include healthy volunteers because it specifically focuses on patients who require these urgent operations due to medical necessity. Eligible participants are those undergoing these specific procedures at Tikur Anbessa Specialized Hospital or other participating public hospitals. While the birth-related portion is for females, the trauma portion includes both men and women, generally of reproductive or working age with no upper age limit. People are excluded if they are having elective surgeries, cannot provide consent, or cannot be reached for the two-year follow-up period. The researchers use a mixed intervention based on the "Clean Cut" safety bundle, which includes staff training, surgical checklists, and regular audits. The main goals are to measure infection rates within 30 days of surgery and track how well patients can function in their daily lives using the WHODAS scale up to 24 months later.
Key facts
- Study ID
- NCT07647796
- Run by
- Karolinska Institutet
- People needed
- 1000
- Starts
- 2026-09-01
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-06-15
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Emergency Caesarean section.
- Open tibia/femur fractures.
- Treated at participating Ethiopian hospitals.
You may not qualify if…
- Elective or non-bellwether surgeries.
- Inability to provide informed consent.
- Lost to follow-up for 24-month assessment.
Where it is running
- Tikkur Anbessa — Addis Ababa, Ethiopia
Full record on ClinicalTrials.gov
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