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NCT Number: NCT07647796

Infection Prevention for "Bellwether" Surgery in Ethiopia

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical Site Infection Prevention and Control (IPC) Bundle

Other

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.

Primary outcomes

  1. Incidence of Surgical Site Infection (SSI)

    Time frame: Up to 30 days post-surgery

    The rate of surgical site infections diagnosed post-operatively.

Secondary outcomes

  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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Sinabulya, Md, PhD

CONTACT

[email protected]

+46705666670

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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