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NOT YET RECRUITING
NCT07647796

Infection Prevention for "Bellwether" Surgery in Ethiopia

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-09-01

Completion Date

2030-08-01

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

OTHER

Surgical Site Infection Prevention and Control (IPC) Bundle

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.

Locations (1)

Tikkur Anbessa

Addis Ababa, Ethiopia