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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Limb Fractures |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Sinabulya, Md, PhD | Contact | +46705666670 | helen.sinabulya@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tikkur Anbessa | Addis Ababa | Ethiopia |
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.
From the start of data collection and until the results are published.
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Culture swaps from surgical sites will be taken. Growth on agar plates and from these cultures the DNA will be extracted for sequencing.
|
| Up to 24 months post-surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |