Ceserean SectionNCT07647796
Infection Prevention for "Bellwether" Surgery in Ethiopia
An observational study of Ceserean Section and Lower Limb Fractures, run by Karolinska Institutet at 1 site in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ceserean Section, Lower Limb Fractures, Surgical Site Infection (SSI)
- How many people
- 1,000 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Sep 2026to 1 Aug 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Emergency Caesarean section.
- Open tibia/femur fractures.
- Treated at participating Ethiopian hospitals.
Who cannot join
- Elective or non-bellwether surgeries.
- Inability to provide informed consent.
- Lost to follow-up for 24-month assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Surgical Site Infection Prevention and Control (IPC) Bundle
- Keywords
- Surgical Site Infections, Global Surgery, Ethiopia, Multidrug resistance, Antimicrobial resistance, Subsahara Africa
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Site Infection Prevention and Control (IPC) BundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Fractures | Not described Receives: Other: Surgical Site Infection Prevention and Control (IPC) Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI)
The rate of surgical site infections diagnosed post-operatively.
Measured: Up to 30 days post-surgery
Secondary outcomes (1)
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).
Measured: Up to 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ceserean SectionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Sinabulya, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647796
- Sponsor's protocol ID
- AMR Ethiopia
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Prevention for "Bellwether" Surgery in Ethiopia: Efficacy, Antimicrobial Resistance, Long-term Patient Outcomes, and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT07647796
- Acronym / sponsor ID
- AMR Ethiopia
- Keywords
- Surgical Site Infections, Global Surgery, Ethiopia, Multidrug resistance, Antimicrobial resistance, Subsahara Africa
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Fractures | – | Other: Surgical Site Infection Prevention and Control (IPC) Bundle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Emergency Caesarean section.
- Open tibia/femur fractures.
- Treated at participating Ethiopian hospitals.
Key exclusion criteria (3 listed)
- Elective or non-bellwether surgeries.
- Inability to provide informed consent.
- Lost to follow-up for 24-month assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Site Infection Prevention and Control (IPC) BundleThis 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. | Other | Lower Limb Fractures |
Primary outcome
Incidence of Surgical Site Infection (SSI)
Time frame: Up to 30 days post-surgery
The rate of surgical site infections diagnosed post-operatively.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Ceserean Section
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
RecruitingPhase 4
Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ceserean Section and Lower Limb Fractures, run by Karolinska Institutet at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Sinabulya, Md, PhD (+46705666670, helen.sinabulya@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection (SSI) (time frame: Up to 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.