Antibacterial-coated Sutures at Time of Cesarean (ASTC)

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications; Surgical Wound Infection; Surgical Site Infection; Cesarean Section; Infection
• Intervention / Treatment: Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures); Other: Vicryl, monocryl, PDS (not coated with triclosan)

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 Type: Interventional
• Enrollment (Estimated): 3374
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Benjamin Bush, M.D.; Phone Number: (409)772-1011; Email: babush@utmb.edu
• Study Contact Backup: Name: Megan Shepherd, M.D.; Phone Number: 4045636251; Email: mcshephe@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • Recruiting
      • University of Texas Medical Branch in Galveston
      • Contact: Benjamin Bush, M.D.; Phone Number: 409-772-1011; Email: babush@utmb.edu
      • Contact: Megan Shepherd, M.D.; Phone Number: (409)772-0982; Email: mcshephe@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of endometritis and/or wound infection and/or other post-cesarean infections	surgical site infection after cesarean	occurring within 30 days of delivery

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Benjamin Bush, M.D., University of Texas Medical Branch in Galveston

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Triclosan
• Other Study ID Numbers: 17-0305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No