Antibacterial-coated Sutures at Time of Cesarean
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.
Conditions:
🦠 Surgical Site Infection 🦠 Surgical Wound Infection 🦠 Cesarean Section; Infection 🦠 Cesarean Section Complications
🗓️ Study Start (Actual) 9 January 2018
🗓️ Primary Completion (Estimated) 30 January 2024
✅ Study Completion (Estimated) 30 January 2024
👥 Enrollment (Estimated) 3374
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Galveston, Texas, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 December 2017
  • First Submitted that Met QC Criteria 28 December 2017
  • First Posted 29 December 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 September 2023
  • Last Update Posted 21 September 2023
  • Last Verified March 2023