Antibiotic-coated Braided Suture Study

University of Miami

Status: Begins enrollment this month

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

Treatments: Device: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial); Device: Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament

Study type: Interventional

Funder types: Other

Identifiers

NCT07322289

20250980

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

142 participants in 2 patient groups

Triclosan-Braided Suture Group

Experimental group

Description:

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.

Treatment:

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

Monofilament Suture Group

Active Comparator group

Description:

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.

Treatment:

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