Antibacterial-coated Sutures at Time of Cesarean

17-0305

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.

2018-01-09

2024-01-30

2024-01-30

Recruiting

Early phase I

3374

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded controlled clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'A confidential computer-generated simple randomization scheme will be prepared and provided on an ongoing basis. A randomization log will be used to track the randomization process. Patients will be masked to the suture material. Both suture types look similar. Patient, surgeons, and staff ascertaining the outcomes will be masked for the suture type.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3374, 'type': 'ESTIMATED'}}

2023-09-21