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Antibacterial-coated Sutures at Time of Cesarean (ASTC)

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ClinicalTrials.gov Identifier: NCT03386240
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Surgical Wound Infection Cesarean Section; Infection Cesarean Section Complications 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-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 : January 9, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Triclosan

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 Name: 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 Name: Control group




Primary Outcome Measures :
  1. Composite of endometritis and/or wound infection and/or other post-cesarean infections [ Time Frame: occurring within 30 days of delivery ]
    surgical site infection after cesarean



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female admitted to labor and delivery
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386240


Contacts
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Contact: Violetta Lozovyy, M.D. 409-772-1571 vilozovy@utmb.edu
Contact: Antonio Saad, M.D. 409-772-0982 afsaad@utmb.edu

Locations
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United States, Texas
University of Texas Medical Branch in Galveston Recruiting
Galveston, Texas, United States, 77550
Contact: Violetta Lozovyy, M.D.    409-772-1571    vilozovy@utmb.edu   
Contact: Antonio Saad, M.D.    (409)772-0982    afsaad@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Study Director: Antonio Saad, M.D. University of Texas Medical Branch in Galveston

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03386240     History of Changes
Other Study ID Numbers: 17-0305
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anti-Bacterial Agents
Triclosan
Anti-Infective Agents
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents