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Antibiotic-coated Braided Suture Study

NCT07322289 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Colin McNamara, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-15
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07322289 on ClinicalTrials.gov