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
This trial does not accept healthy volunteersQualifiers
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 population
The study population comprises Ethiopian patients requiring emergency "Bellwether" surgeries at Tikur Anbessa Specialized Hospital and participating public facilities. Specifically, the cohort includes women undergoing Caesarean sections and individuals of both sexes presenting with open tibia or femur fractures. The population represents adult clinical cases requiring urgent surgical intervention, excluding healthy volunteers and elective procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical Site Infection Prevention and Control (IPC) Bundle
Other interventionThis 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Lower Limb Fractures1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Surgical Site Infection (SSI)
The rate of surgical site infections diagnosed post-operatively.
Time frame
Up to 30 days post-surgerySecondary outcomes
1
Long-term Functional Health Status Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
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).
Time frame
Up to 24 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov
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