Surgical Site Infections at a West Cameroon Hospital (SSI Mbouo)

March 15, 2022 updated by: Christian Doll

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

Completed

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ouest
      • Bafoussam, Ouest, Cameroon, 948
        • Hôpital Protestant de Mbouo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients that receive surgery at the Hôpital Protestant de Mbouo in Cameroon and that are willing and consenting to participate in the study

Description

Inclusion Criteria:

  • Patient underwent surgery at the hospital during study period

Exclusion Criteria:

  • Unconscious patients, mentally ill patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Sponsor

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Actual)

February 4, 2022

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After the end of the study, IPD may be shared on request by other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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