- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018884
Surgical Site Infections at a West Cameroon Hospital (SSI Mbouo)
Incidence, Microbial Spectrum and Risk Factors of Surgical Site Infections at a West Cameroon Hospital: A Prospective Cohort Study
Surgical site infections (SSI) constitute an important health concern in low and middle income countries, leading to prolonged hospital stay and increased costs. Previous studies indicate that in Africa up to 1/3 of patients undergoing surgery may be affected by a postoperative infection. The development and implementation of context-specific SSI prevention guidelines is important to reduce this complication. To deploy efficient context-specific measures, data on epidemiology and microbiology of these infections are needed. This means to adapt the prevention measures to the context-specific risk factors for surgical site infections in resource-limited settings, and to give locally adapted recommendations on antimicrobial therapy based on local resistance patterns. However, data in this respect are scarce in low and middle income countries. This present study will contribute to the needed epidemiology and microbiology data on SSI in Cameroon. It will be carried out as a prospective cohort study at the Mbouo Protestant hospital in the West Region of Cameroon. The incidence, microbial spectrum and respective antimicrobial resistance of SSI as well as the risk factors of SSI will be systematically investigated. The study will include 300 patients at the Hôpital Protestant de Mbouo (HPM) who underwent surgery and gave their informed consent for inclusion, the timeframe is 04/2021 - 11/2021. An active SSI surveillance system will be put in place for 30 postoperative days to diagnose SSI.
Expected outcomes:
The incidence of SSI is likely to be higher than 10%. Concerning risk factors, preoperative bodywashing and perioperative antibioprophylaxis is expected to be protective against SSI. Up to 1/3 of SSI are expected to occur after hospital discharge. For the microbial spectrum, a high proportion of Staphylococcus aureus is likely to be found. For the antimicrobial resistance no estimation can be give as data is non-existent in that region from the literature.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ouest
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Bafoussam, Ouest, Cameroon, 948
- Hôpital Protestant de Mbouo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient underwent surgery at the hospital during study period
Exclusion Criteria:
- Unconscious patients, mentally ill patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients without SSI
Patients who underwent surgery and who developed a surgical site infection (SSI) during 30 days after surgery
|
|
Patients with SSI
Patients who underwent surgery and who didn't develop a surgical site infection (SSI) during 30 days after surgery
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No intervention is done, only observation of routine clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Surgical Site Infections (SSI)
Time Frame: 04 / 2021 - 11 / 2021
|
The incidence of SSI of all patients included in the study
|
04 / 2021 - 11 / 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors of SSI
Time Frame: 04 / 2021 - 11 / 2021
|
What are the risk factors for Surgical site infections?
|
04 / 2021 - 11 / 2021
|
Microbial spectrum of SSI
Time Frame: 04 / 2021 - 11 / 2021
|
What is the microbial spectrum of Surgical site infections?
|
04 / 2021 - 11 / 2021
|
Post-operative mortality
Time Frame: 04 / 2021 - 11 / 2021
|
What is the postoperative mortality of all patients included in the study during hospitalisation for a maximum of 30 days after surgery?
|
04 / 2021 - 11 / 2021
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Doll, Dr, Université Evangélique du Cameroun, Cameroon; Hôpital Protestant de Mbouo, Cameroon; Charité University Medical Centre Berlin, Germany; University Medical Centre Jena, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSI Mbouo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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