Antibacterial-coated Sutures at Time of Cesarean

The University of Texas Medical Branch, Galveston1,122 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,122

Conditions

Surgical Site Infection Surgical Wound Infection Cesarean Section; Infection Cesarean Section Complications

Interventions

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)DRUG

The intervention consists of using Plus group (Triclosan-coated Sutures)

Vicryl, monocryl, PDS (not coated with triclosan)OTHER

Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Texas Medical Branch in Galveston

Galveston, Texas, United States

Outcomes

Primary Outcomes

Composite of endometritis and/or wound infection and/or other post-cesarean infections

surgical site infection after cesarean

Time frame: occurring within 30 days of delivery

Data from ClinicalTrials.gov

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