Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blinded controlled clinical trial
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
A confidential computer-generated simple randomization scheme will be prepared and provided on an ongoing basis. A randomization log will be used to track the randomization process. Patients will be masked to the suture material. Both suture types look similar. Patient, surgeons, and staff ascertaining the outcomes will be masked for the suture type.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
    The intervention consists of using Plus group (Triclosan-coated Sutures)
    Other names:
    • Plus group
Placebo Comparator
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.
  • Other: Vicryl, monocryl, PDS (not coated with triclosan)
    Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
    Other names:
    • Control group

Recruiting Locations

University of Texas Medical Branch in Galveston
Galveston, Texas 77550
Contact:
Violetta Lozovyy, M.D.
409-772-1571
vilozovy@utmb.edu

More Details

NCT ID
NCT03386240
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Violetta Lozovyy, M.D.
409-772-1571
vilozovy@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.