Antibiotic-coated Braided Suture Study

NCT ID: NCT07322289

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to evaluate whether the use of antibiotic-coated (triclosan) braided sutures is non-inferior or potentially superior to standard monofilament sutures in patients with prosthetic joint infections (PJIs) managed with the DAIR protocol. Several studies in various surgical specialties have demonstrated the effectiveness and non-inferiority of triclosan-coated braided sutures in infected surgical cases, and the study intends to transpose this idea to the management of prosthetic joint infections. Monofilament sutures are the present standard of care in any infected joint case due their lower surface area for bacterial harborization, though surgeons sacrifice mechanical integrity and comfortability with the closure in the process. By demonstrating the safety of antibiotic -coated braided sutures, surgeons will no longer have to make this compromise.

Conditions

Prosthetic Joint Infection; Debridement With Prosthesis Retention; Prosthetic Joint Infections of Hip; Prosthetic Joint Infections of Knee; Suture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Triclosan-Braided Suture Group

Patients randomized to this arm will receive triclosan-coated braided sutures for closure of the fascia. Following incision and full debridement and irrigation, the fascia will be closed with this suture. Suturing of the fascia typically takes \~10 minutes. As this suture is absorbable, it does not have to be removed. The superficial layers of the skin will be closed with nylon suture.

Group Type: EXPERIMENTAL

VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)

Intervention Type: DEVICE

Synthetic, absorbable, braided suture coated with triclosan for antimicrobial protection. Used for fascial and skin closure. Offers high tensile strength and knot security

Monofilament Suture Group

Patients randomized to this arm will receive monofilament sutures for closure of the fascia. Following incision and full debridement and irrigation, the fascia will be closed with this suture. Suturing of the fascia typically takes \~10 minutes. As this suture is absorbable, it does not have to be removed. The superficial layers of the skin will be closed with nylon suture.

Group Type: ACTIVE_COMPARATOR

Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament

Intervention Type: DEVICE

Absorbable, non-braided suture. Used for fascial and skin closure.

Interventions

VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)

Synthetic, absorbable, braided suture coated with triclosan for antimicrobial protection. Used for fascial and skin closure. Offers high tensile strength and knot security

Intervention Type: DEVICE

Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament

Absorbable, non-braided suture. Used for fascial and skin closure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Willing and able to provide informed consent
• Primary Total Hip Arthroplasty or Total Knee Arthroplasty with Prosthetic Joint Infection Musculoskeletal Infection Society (MSIS) criteria
• Prosthetic Joint Infection Treated with Debridement, Antibiotics, Implant Retention

Acute Prosthetic Joint Infection: <4 weeks since it was suspected/diagnosed

Exclusion Criteria

• Staphylococcus aureus bacteremia
• Mycobacterial, fungal, or parasitic infection
• Concurrent infection needing prolonged Intravenous therapy
• Septic shock/systemic illness needing IV therapy
• Patients with severe immunosuppression (ex: chemotherapy,

neutropenia, HIV, steroid use

• Allergy to Triclosan
• Pregnancy
• Prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Colin A. McNamara

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin McNamara, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Health System

Miami, Florida, United States

Countries

United States

Central Contacts

Andrew R Moya, MD

Role: CONTACT

arm577@miami.edu

786-856-6463

Facility Contacts

Andrew R Moya, MD

Role: primary

arm577@miami.edu

786-856-6463

Other Identifiers

20250980

Identifier Type: -

Identifier Source: org_study_id