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Not Yet Recruiting NCT07322289

Antibiotic-coated Braided Suture Study

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

Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: NA
Enrollment: 142
Sponsor: University of Miami

Location: University of Miami Health System Miami Florida

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.

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: \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07322289). StuddyBuddy aggregates publicly available trial information.