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ASTC: Antibacterial-coated Sutures at Time of Cesarean

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Recruiting
CT.gov ID
NCT03386240
Collaborator
(none)
3,374
Enrollment
1
Location
2
Arms
59.7
Anticipated Duration (Months)
56.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
  • Other: Vicryl, monocryl, PDS (not coated with triclosan)
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
3374 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blinded controlled clinical trialDouble-blinded controlled clinical trial
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.
Primary Purpose:
Treatment
Official Title:
Antibacterial-coated Sutures at Time of Cesarean
Actual Study Start Date :
Jan 9, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite of endometritis and/or wound infection and/or other post-cesarean infections [occurring within 30 days of delivery]

      surgical site infection after cesarean

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Medical Branch in Galveston Galveston Texas United States 77550

    Sponsors and Collaborators

    • The University of Texas Medical Branch, Galveston

    Investigators

    • Study Director: Antonio Saad, M.D., University of Texas Medical Branch in Galveston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Medical Branch, Galveston
    ClinicalTrials.gov Identifier:
    NCT03386240
    Other Study ID Numbers:
    • 17-0305
    First Posted:
    Dec 29, 2017
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection
    Wound Infection
    Surgical Wound
    Triclosan

    Study Results

    No Results Posted as of Feb 11, 2022