Maternal Cesarian Section Infection (MACSI) in Sierra Leone
NCT ID: NCT03929991
Last Updated: 2019-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2018-05-01
2020-05-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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:
* Superficial incisional surgical site infection,
* Deep incisional surgical site infection,
* Organ/space surgical site infection.
Observational
To record social and clinical characteristics
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
Observational
To record social and clinical characteristics
Interventions
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Observational
To record social and clinical characteristics
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Vaginosis, candidiasis
* Lower tract urinary infection
* Fungal infections of the skin (athlete's foot, jockitch, ringworm, and yeast infections)
* Otitis
* Pharyngitis
* Herpes simplex, Herpes Zoster (Shingles)
* Uncomplicated chronic infection
* Sexually transmitted infections (Gonorrhoea, Syphilis, Trichomonas, Chlamydia, Hepatitis, HIV)
* Tuberculosis
* Bacterial colonization (presence of microorganisms without clinical signs/symptoms)
* Known vaginal, urethral and/or rectal GBS colonization
* Asymptomatic bacteriuria
* Known oropharyngeal colonization
* Non-infectious hypothermia/hyperthermia (e.g. related to epidural, thyroid storm, prostaglandin administration) during hospital stay
FEMALE
No
Sponsors
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University of Bari
OTHER
University of Palermo
OTHER
Doctors with Africa - CUAMM
OTHER
Responsible Party
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Principal Investigators
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Giovanni Putoto, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of operational research Doctors with Africa CUAMM Padova, Italy
Locations
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Princess Christian Maternity Hospital
Freetown, , Sierra Leone
Countries
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Central Contacts
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Facility Contacts
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Francesco Di Gennaro
Role: primary
Other Identifiers
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1902
Identifier Type: -
Identifier Source: org_study_id