Antibacterial-coated Sutures at Time of Cesarean

NCT03386240 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1122

Last updated 2025-01-06

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection
  • Surgical Wound Infection
  • Cesarean Section; Infection
  • Cesarean Section Complications

Interventions

DRUG

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

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

OTHER

Vicryl, monocryl, PDS (not coated with triclosan)

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

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Benjamin Bush, M.D. · University of Texas Medical Branch in Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2024-11-22
Completion
2024-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386240 on ClinicalTrials.gov