Surgical Wound InfectionSSI MbouoNCT05018884
Surgical Site Infections at a West Cameroon Hospital
An observational study of Surgical Wound Infection, run by Christian Doll at 1 site in Cameroon.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Observation of surgical site infections
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteCameroon
- Study dates
- 26 Apr 2021to 4 Feb 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients that receive surgery at the Hôpital Protestant de Mbouo in Cameroon and that are willing and consenting to participate in the study
Who may be able to join
- Patient underwent surgery at the hospital during study period
Who cannot join
- Unconscious patients, mentally ill patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgical Wound Infection
- Being tested
- Observation of surgical site infections
- 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.
Observation of surgical site infectionsProcedure or surgery
No intervention is done, only observation of routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Observation of surgical site infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infections (SSI)
The incidence of SSI of all patients included in the study
Measured: 04 / 2021 - 11 / 2021
Secondary outcomes (3)
Risk factors of SSI
What are the risk factors for Surgical site infections?
Measured: 04 / 2021 - 11 / 2021
Microbial spectrum of SSI
What is the microbial spectrum of Surgical site infections?
Measured: 04 / 2021 - 11 / 2021
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?
Measured: 04 / 2021 - 11 / 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start26 Apr 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- 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
- 148 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Christian Doll
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor-investigator, Christian Doll, Universite Evangelique du Cameroun
- Investigators
- Christian Doll, Dr, Principal investigator, Université Evangélique du Cameroun, Cameroon; Hôpital Protestant de Mbouo, Cameroon; Charité University Medical Centre Berlin, Germany; University Medical Centre Jena, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018884
- Sponsor's protocol ID
- SSI Mbouo
- Acronym
- SSI Mbouo
- Status last verified
- Mar 2022
- First submitted
- 17 Aug 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the end of the study, IPD may be shared on request by other researchers
Publications
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.
PubMed 41044533
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Microbial Spectrum and Risk Factors of Surgical Site Infections at a West Cameroon Hospital: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05018884
- Acronym / sponsor ID
- SSI Mbouo / SSI Mbouo
- Conditions
- Surgical Wound Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Christian DollUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 24 Aug 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without SSI | – | –Patients who underwent surgery and who developed a surgical site infection (SSI) during 30 days after surgery |
| Patients with SSI | – | Procedure: Observation of surgical site infectionsPatients who underwent surgery and who didn't develop a surgical site infection (SSI) during 30 days after surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patient underwent surgery at the hospital during study period
Key exclusion criteria (1 listed)
- Unconscious patients, mentally ill patients
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 |
|---|---|---|
| Observation of surgical site infectionsNo intervention is done, only observation of routine clinical practice | Procedure or surgery | Patients with SSI |
Primary outcome
Incidence of Surgical Site Infections (SSI)
Time frame: 04 / 2021 - 11 / 2021
The incidence of SSI of all patients included in the study
3 secondary outcomes
Risk factors of SSI
Time frame: 04 / 2021 - 11 / 2021
Microbial spectrum of SSI
Time frame: 04 / 2021 - 11 / 2021
Post-operative mortality
Time frame: 04 / 2021 - 11 / 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 41044533Doll 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.
- Individual participant dataSharing planned: Undecided. After the end of the study, IPD may be shared on request by other researchers
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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. This study is not recruiting at the moment.
Christian Doll, Dr principal investigator
Université Evangélique du Cameroun, Cameroon; Hôpital Protestant de Mbouo, Cameroon; Charité University Medical Centre Berlin, Germany; University Medical Centre Jena, Germany
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 Surgical Wound Infection, run by Christian Doll at 1 site in Cameroon.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Mar 2022. 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 Cameroon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infections (SSI) (time frame: 04 / 2021 - 11 / 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018884, which also lists 1 linked publication.
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 16 Mar 2022.