NCT05018884

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

August 17, 2021

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Surgical Site Infections (SSI)

    The incidence of SSI of all patients included in the study

    04 / 2021 - 11 / 2021

Secondary Outcomes (3)

  • Risk factors of SSI

    04 / 2021 - 11 / 2021

  • Microbial spectrum of SSI

    04 / 2021 - 11 / 2021

  • Post-operative mortality

    04 / 2021 - 11 / 2021

Study Arms (2)

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

Procedure: Observation of surgical site infections

Interventions

No intervention is done, only observation of routine clinical practice

Patients with SSI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patient underwent surgery at the hospital during study period

You may not qualify if:

  • Unconscious patients, mentally ill patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Protestant de Mbouo

Bafoussam, West Region, 948, Cameroon

Location

Related Publications (1)

  • Doll C, Ndoho Simo LC, Jeulefack H, Tamuedjoun Talom A, Kuate Kamdem L, Kenmogne JB, Djeunang Dongho GB, Trampuz A. Efforts in surgical site infection surveillance at the Mbouo Protestant Hospital in Cameroon. BMC Surg. 2025 Oct 3;25(1):419. doi: 10.1186/s12893-025-03229-5.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Doll, Dr

    Université Evangélique du Cameroun, Cameroon; Hôpital Protestant de Mbouo, Cameroon; Charité University Medical Centre Berlin, Germany; University Medical Centre Jena, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med. Christian Doll

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 24, 2021

Study Start

April 26, 2021

Primary Completion

February 4, 2022

Study Completion

February 4, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations