Antibiotic-coated Braided Suture Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Staphylococcus aureus bacteremia

Mycobacterial, fungal, or parasitic infection

Concurrent infection needing prolonged Intravenous therapy

Septic shock/systemic illness needing IV therapy

Trial design

Treatments tested in this trial

  • VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)
  • Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament

Treatment groups

142 Participants
are divided into 2 treatment groups

Sponsors and collaborators