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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03386240
Other study ID # 17-0305
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 9, 2018
Est. completion date January 30, 2024

Study information

Verified date March 2023
Source The University of Texas Medical Branch, Galveston
Contact Benjamin Bush, M.D.
Phone (409)772-1011
Email babush@utmb.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.


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 are no clinical trials focusing on cesarean delivery, and because the risk factors and pathogenesis for post-cesarean SSI may not mirror other procedures, further data is needed before generalizing the WHO recommendations to cesarean procedures.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
The intervention consists of using Plus group (Triclosan-coated Sutures)
Other:
Vicryl, monocryl, PDS (not coated with triclosan)
Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.

Locations

Country Name City State
United States University of Texas Medical Branch in Galveston Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

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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