Infection Prevention for "Bellwether" Surgery in Ethiopia (NCT07647796) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Infection Prevention for "Bellwether" Surgery in Ethiopia
Ethiopia1,000 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Emergency Caesarean section.
* Open tibia/femur fractures.
* Treated at participating Ethiopian hospitals.
Exclusion Criteria:
* Elective or non-bellwether surgeries.
* Inability to provide informed consent.
* Lost to follow-up for 24-month assessment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically focused on cesarean sections and lower limb fractures in Ethiopia — would my particular surgery or situation even be relevant to what this study is testing for infection prevention?
2Since this trial hasn't started recruiting yet, how long might it realistically be before it opens, and would waiting to potentially participate affect the timing of care I need right now?
3The trial is measuring surgical site infection rates as its main outcome — what does my doctor currently do to prevent SSIs in my type of surgery, and how might that compare to whatever approach this study is evaluating?
4Because this trial is listed as Phase NA, which often means it's more of an observational or procedural study rather than a drug trial, can my doctor help me understand what participating would actually involve and whether there are any direct risks or benefits to me personally?
5If this study is being conducted in Ethiopia and I'm not located there, is there any way this research could still be relevant to my care, or are there similar infection prevention studies closer to home that my doctor might know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.