Antibacterial-coated Sutures at Time of Cesarean

NCT03386240 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-0305
• Study Type: interventional
• Target: 1,169
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Maternal Deaths

  Within 30 days following delivery

• Participants With Wound Hematoma or Seroma

  Within 30 days following delivery

• Participants With Puerperal Fever

  Within 30 days following 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

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female admitted to labor and delivery
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch in Galveston

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Interventions

Population Groups; Polyglactin 910; glycolide E-caprolactone copolymer; Triclosan; Control Groups

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

The study began in January 2018 and underwent multiple Principal Investigator (PI) transitions. The data provided represents the information currently available to the study team.

Results Point of Contact

• Title: Gayle Olson Koutrouvelis, MD, MPH
• Organization: UTMB

golson@utmb.edu

409-747-4905

Study Officials

• Benjamin Bush, M.D.

  University of Texas Medical Branch in Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded controlled clinical trial

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: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)