Infection Clinical Trial
Official title:
Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study
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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