Trials / Not Yet Recruiting
Not Yet RecruitingNCT07322289
Antibiotic-coated Braided Suture Study
Evaluating the Use of Antibiotic-Coated Braided Sutures in Debridement, Antibiotic, and Implant Retention (DAIR) Procedures
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
| DEVICE | Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament | Absorbable, non-braided suture. Used for fascial and skin closure. |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2027-07-15
- Completion
- 2027-12-31
- First posted
- 2026-01-07
- Last updated
- 2026-03-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07322289. Inclusion in this directory is not an endorsement.