Antibiotic-coated Braided Suture Study

NCT07322289 | Not Yet Recruiting FDA Device

• 1 other identifier: 20250980
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

prosthetic joint infection; debridement, antibiotics, implant retention; antibiotic coated braided sutures; monofilament suture

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with treatment failure at 90 days

  Treatment failure is defined by Musculoskeletal Infection Society Criteria for prosthetic joint infection, including persistent wound drainage, sinus tract formation, positive cultures, or need for surgical revision.The proportion will be calculated as the number of patients meeting any MSIS treatment-failure criterion divided by the total number of patients evaluated. Assessment will be based on clinical evaluation and microbiological data collected at 90 days post-treatment.

  90 days post treatment

Secondary Outcomes (5)

• Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient)

  Within 90 days of surgery

• Incidence of Wound Dehiscence

  Up to 90 days post-operative

• Incidence of Superficial Site Infection

  Up to 90 days post-operative

• Incidence of Seroma Formation

  Up to 90 days post-operative

• Incidence of Delayed Wound Healing

  Up to 90 days post-operative

Study Arms (2)

Triclosan-Braided Suture Group

EXPERIMENTAL

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.

Device: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)

Monofilament Suture Group

ACTIVE COMPARATOR

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.

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

Interventions

VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial) DEVICE

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

Triclosan-Braided Suture Group

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

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

Monofilament Suture Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Health System

Miami, Florida, 33132, United States

Location

Study Officials

• Colin McNamara, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Moya, MD

CONTACT

786-856-6463; arm577@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)