Infection Prevention for "Bellwether" Surgery in Ethiopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical Site Infection Prevention and Control (IPC) Bundle.
- Who it may be relevant to
- Registry conditions: Ceserean Section, Lower Limb Fractures, Surgical Site Infection (SSI). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Infection Prevention for "Bellwether" Surgery in Ethiopia: Efficacy, Antimicrobial Resistance, Long-term Patient Outcomes, and Cost-effectiveness
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.
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 eva
Primary outcome measures
- Incidence of Surgical Site Infection (SSI) [Time frame: Up to 30 days post-surgery]
Secondary outcome measures (1)
- Long-term Functional Health Status Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Time frame: Up to 24 months post-surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ethiopia · 1 center
- Tikkur Anbessa — Addis Ababa
Identifiers
NCT: NCT07647796 · AMR Ethiopia