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| Name | Class |
|---|---|
| University of Bari | OTHER |
| University of Palermo | OTHER |
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Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection.
Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery.
The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI.
Rationale: More than 1 in 10 people who have surgery in low and middle-income countries (LMICs) get surgical site infection. People's risk of SSI in LMICs is 3 to 5 times higher than in high-income countries. Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection.
Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery.
Objective: The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI.
Study design: This is a prospective case-control (1:3 ratio) study. Study population and Methods: All women admitted or already hospitalized with suspected or confirmed infection after C/S will be screened for inclusion in the study as a case. Case confirmation will be clinically established by an infectious disease expert. For each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting SSI, will be selected as controls.
Sample size: No formal sample size calculation is performed.
Main study parameters/primary endpoints: SSI post C/S will be classified as:
Superficial incisional surgical site infection, Deep incisional surgical site infection; Organ/space surgical site infection Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Because all proceedings in the method of this study are based on common clinical practice, there are no serious adverse events (SAEs) expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | All women admitted or already hospitalized with suspected or confirmed infection after C/S will be screened for inclusion in the study as a case. Case confirmation will be clinically established by an infectious disease expert.SSI post C/S will be classified as:
|
| |
| Control | For each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting Surgical Site Infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | To record social and clinical characteristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence | To determine the incidence of SSI after CS at PCMH during the study period | From hospital admission to hospital discharge, an overage of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Main Features | To describe the main features of SSI after CS in women admitted at PCMH | From hospital admission to hospital discharge, an overage of 1 month |
| Prevalence of Negative Outcome |
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Inclusion Criteria:
Exclusion Criteria:
The following conditions will not be considered as outcome, unless they present with systemic repercussion due to infection. For example:
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All women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
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Pregnant women undergoing a C/S in an urban tertiary referral maternity hospital PCMH, Freetown (population served: 1'500'000; n. of total deliveries in 2017: 6'861; number of C/S in 2017: 2'028 ).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Di Gennaro, MD | Contact | 3924804707 | cicciodigennaro@yahoo.it | |
| Giovanni Putoto, PhD | Contact | 3475791347 | g.putoto@cuamm.org |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Putoto, PhD | Department of operational research Doctors with Africa CUAMM Padova, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Christian Maternity Hospital | Recruiting | Freetown | Sierra Leone |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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To assess predictor of negative outcomes of SSI after CS
| From hospital admission to hospital discharge, an overage of 1 month |
| Screening of Risk factors | To determine the risk factors of Surgical Site Infection post Cesarean Section | From hospital admission to hospital discharge, an overage of 1 month |