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Infection Prevention for "Bellwether" Surgery in Ethiopia

NCT07647796 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

  • Ceserean Section
  • Lower Limb Fractures
  • Surgical Site Infection (SSI)

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.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2030-08-01
Completion
2030-08-01

Countries

  • Ethiopia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647796 on ClinicalTrials.gov