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: Terminated
• 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 (Actual): 1169
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • University of Texas Medical Branch in Galveston

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
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections	Number of Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections post-cesarean infections occurring within 30 days of delivery, including endometritis, wound infection, or other infections. Endometritis: Presence of two or more of the following signs with no other identified etiology: fever (>38°C or >100.4°F), abdominal pain, fundal tenderness, or cervical/vaginal purulent discharge. Wound Infection: Presence of superficial or deep incisional surgical site infection (SSI), including cellulitis/erythema, induration around the incision, or purulent discharge from the incision site with or without fever, including necrotizing fasciitis. Wound hematoma, seroma, or wound breakdown alone without signs of infection was not considered infection. Other Infections: Pelvic septic thrombosis diagnosed based on persistent signs of endometritis with or without radiologic confirmation, or abdominal/pelvic abscess confirmed radiologically.	Within 30 days following delivery
Participants With Surgical Site Infection	Number of participants who developed a surgical site infection (SSI) following cesarean delivery.	Within 30 days following delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Deaths	Number of Maternal Deaths.	Within 30 days following delivery
Participants With Wound Hematoma or Seroma	Number of participants who developed wound hematoma or seroma following cesarean delivery. Wound hematoma was defined as a localized collection of blood at the incision site, and seroma was defined as a localized accumulation of serous fluid at the incision site identified during the postoperative follow-up period.	Within 30 days following delivery
Participants With Puerperal Fever	Number of participants who developed puerperal fever following cesarean delivery. Puerperal fever was defined as a temperature >100.4°F occurring after the first 24 hours postpartum or a temperature ≥101°F occurring at any time during the postpartum period.	Within 30 days following 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 (Actual): November 22, 2024
• Study Completion (Actual): November 22, 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): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Wound Infection; Pathological Conditions, Signs and Symptoms; Infections; Surgical Wound Infection; Organic Chemicals; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Ethers; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Population Characteristics; Phenols; Benzene Derivatives; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Demography; Phenyl Ethers; Polyesters; Triclosan; Control Groups; Population Groups; Polyglactin 910; glycolide E-caprolactone copolymer
• 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