Infection Prevention for "Bellwether" Surgery in Ethiopia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

Qualifiers

Emergency Caesarean section.

Open tibia/femur fractures.

Treated at participating Ethiopian hospitals.

Disqualifiers

Elective or non-bellwether surgeries.

Inability to provide informed consent.

Lost to follow-up for 24-month assessment.

Trial design

Treatments tested in this trial

  • Surgical Site Infection Prevention and Control (IPC) Bundle

Treatment groups

1,000 Participants
are divided into 1 treatment group

Sponsors and collaborators