Surgical Site Infections at a West Cameroon Hospital

Surgical Wound Infection Clinical Trial

— SSI Mbouo  

Official title:

Incidence, Microbial Spectrum and Risk Factors of Surgical Site Infections at a West Cameroon Hospital: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018884
• Other study ID #: SSI Mbouo
• Status: Completed
• Start date: April 26, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: March 2022
• Source: Universite Evangelique du Cameroun
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient underwent surgery at the hospital during study period

Exclusion Criteria:

• Unconscious patients, mentally ill patients

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• Observation of surgical site infections
No intervention is done, only observation of routine clinical practice

Locations

Country	Name	City	State
Cameroon	Hôpital Protestant de Mbouo	Bafoussam	Ouest

Sponsors (2)

Lead Sponsor	Collaborator
Christian Doll	Charite University, Berlin, Germany

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Surgical Site Infections (SSI)	The incidence of SSI of all patients included in the study	04 / 2021 - 11 / 2021
Secondary	Risk factors of SSI	What are the risk factors for Surgical site infections?	04 / 2021 - 11 / 2021
Secondary	Microbial spectrum of SSI	What is the microbial spectrum of Surgical site infections?	04 / 2021 - 11 / 2021
Secondary	Post-operative mortality	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