Infection Prevention for "Bellwether" Surgery in Ethiopia

N/ANot Yet RecruitingNCT07647796

Karolinska Institutet1,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Ceserean Section Lower Limb Fractures Surgical Site Infection (SSI)

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Surgical Site Infection (SSI)

The rate of surgical site infections diagnosed post-operatively.

Time frame: Up to 30 days post-surgery

Secondary Outcomes

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-surgery