Status:
COMPLETED
Antibacterial-coated Sutures at Time of Cesarean
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Surgical Site Infection
Surgical Wound Infection
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
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 obj...
Detailed Description
A review of 18 studies demonstrated a significant benefit of antimicrobial coated sutures in reducing SSI (RCTs: OR 0.72; 95% CI 0.59-0.88; observational studies: OR 0.58; 95% CI 0.40-0.83). As there ...
Eligibility Criteria
Inclusion
- 18-50 years of age.
- Women ≥ 24 weeks' viable gestation.
- To undergo cesarean delivery.
Exclusion
- 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.
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2024
Estimated Enrollment :
1122 Patients enrolled
Trial Details
Trial ID
NCT03386240
Start Date
January 9 2018
End Date
November 22 2024
Last Update
January 6 2025
Active Locations (1)
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1
University of Texas Medical Branch in Galveston
Galveston, Texas, United States, 77550