NCT03386240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,122

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

6.9 years

First QC Date

December 21, 2017

Last Update Submit

January 2, 2025

Conditions

Surgical Site InfectionSurgical Wound InfectionCesarean Section; InfectionCesarean Section Complications

Outcome Measures

Primary Outcomes (1)

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

    surgical site infection after cesarean

    occurring within 30 days of delivery

Study Arms (2)

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

EXPERIMENTAL

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)

Vicryl, monocryl, PDS (not coated with triclosan)

PLACEBO COMPARATOR

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)

Interventions

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

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

Also known as: Plus group
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures
Vicryl, monocryl, PDS (not coated with triclosan)OTHER

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

Also known as: Control group
Vicryl, monocryl, PDS (not coated with triclosan)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale admitted to labor and delivery
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age.
  • Women ≥ 24 weeks' viable gestation.
  • To undergo cesarean delivery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch in Galveston

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Surgical Wound InfectionInfections

Interventions

Population GroupsPolyglactin 910glycolide E-caprolactone copolymerTriclosanControl Groups

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsPolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePhenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Benjamin Bush, M.D.

    University of Texas Medical Branch in Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 29, 2017

Study Start

January 9, 2018

Primary Completion

November 22, 2024

Study Completion

November 22, 2024

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)