Antibacterial-coated Sutures at Time of Cesarean

Phase 4

Completed

• Conditions: Surgical Site Infection; Cesarean Section; Infection; Surgical Wound Infection; Cesarean Section Complications
• Interventions: Other: Vicryl, monocryl, PDS (not coated with triclosan); Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)

• Registration Number: NCT03386240
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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

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 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.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-28
• Study First Posted: 2017-12-29
• Study Start: 2018-01-09
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vicryl, monocryl, PDS (not coated with triclosan)	Vicryl, monocryl, PDS (not coated with triclosan)	Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures	Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)	Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.

Primary Outcome Measures

Name	Time	Method
Composite of endometritis and/or wound infection and/or other post-cesarean infections	occurring within 30 days of delivery	surgical site infection after cesarean

Trial Locations

Locations (1)

University of Texas Medical Branch in Galveston; 🇺🇸 Galveston, Texas, United States