Surgical Site Infection Clinical Trial
— ASTCOfficial title:
Antibacterial-coated Sutures at Time of Cesarean
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.
Status | Recruiting |
Enrollment | 3374 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 18-50 years of age. - Women = 24 weeks' viable gestation. - To undergo cesarean delivery. Exclusion Criteria: - Patient unwilling or unable to provide consent. - No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery. - Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other. - Decision to use other than suture closure (e.g. secondary wound closure, mesh closure). - Skin infection. - Coagulopathy. - High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery). - Allergy to Triclosan. - Incarcerated individuals. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Medical Branch in Galveston | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of endometritis and/or wound infection and/or other post-cesarean infections | surgical site infection after cesarean | occurring within 30 days of delivery |
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