Infection Prevention for "Bellwether" Surgery in Ethiopia

NCT07647796 — Not yet recruiting, 1000 participants, Karolinska Institutet

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Infection Prevention for "Bellwether" Surgery in Ethiopia: Efficacy, Antimicrobial Resistance, Long-term Patient Outcomes, and Cost-effectiveness

Registry	NCT07647796
Status	Not yet recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	Karolinska Institutet (Other)
Conditions	Ceserean Section, Lower Limb Fractures, Surgical Site Infection (SSI)
Interventions	Surgical Site Infection Prevention and Control (IPC) Bundle (Other)
Dates	start 2026-09-01 (estimated), primary completion 2030-08-01 (estimated), completion 2030-08-01 (estimated), first posted 2026-06-15, last updated 2026-06-15
Locations	1 site in Ethiopia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lower Limb Fractures		Other: Surgical Site Infection Prevention and Control (IPC) Bundle

Surgical Site Infection Prevention and Control (IPC) Bundle (Other): This intervention is a multi-modal infection prevention and control (IPC) bundle adapted from the Clean Cut program specifically for emergency "Bellwether" surgeries, including Caesarean sections and open limb fractures, within the Ethiopian public health system. The bundle incorporates routine sterilization audits and the establishment of structured feedback loops to improve perioperative routines and ensure high adherence to hygiene protocols. Furthermore, this intervention is specifically evaluated for its impact on both short-term infection rates and long-term functional recovery, integrating clinical outcomes with antimicrobial resistance (AMR) surveillance.

+Outcome measures

Primary outcomes

Incidence of Surgical Site Infection (SSI) [Up to 30 days post-surgery]: The rate of surgical site infections diagnosed post-operatively.

Secondary outcomes

Long-term Functional Health Status Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Up to 24 months post-surgery]: Functional health status and disability will be measured using the unabbreviated World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The WHODAS 2.0 yields a total quantitative score ranging from a minimum of 0 to a maximum of 100. A score of 0 represents no disability (a better outcome), while a score of 100 represents full disability (a worse outcome).

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
Tikkur Anbessa	Addis Ababa	Ethiopia