Infection Prevention for "Bellwether" Surgery in Ethiopia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Fractures; Surgical Site Infection (SSI); Ceserean Section
• Intervention / Treatment: Other: Surgical Site Infection Prevention and Control (IPC) Bundle

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Helen Sinabulya, Md, PhD; Phone Number: +46705666670; Email: helen.sinabulya@ki.se

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Tikkur Anbessa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Lower Limb Fractures

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection (SSI)	The rate of surgical site infections diagnosed post-operatively.	Up to 30 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 months post-surgery

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Antimicrobial resistance; Ethiopia; Surgical Site Infections; Multidrug resistance; Global Surgery; Subsahara Africa
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: AMR Ethiopia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the primary and secondary outcomes, specifically clinical diagnosis of surgical site infections, microbiological antimicrobial resistance profiles, and long-term functional recovery scores using WHODAS 2.0, will be shared. This includes relevant demographic variables, such as age and sex, to facilitate further meta-analyses while ensuring participant anonymity. Data related to hospital-level implementation and cost-effectiveness metrics will also be made available to qualified researchers upon reasonable request.
• IPD Sharing Time Frame: From the start of data collection and until the results are published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No