Antibiotic-coated Braided Suture Study

Evaluating the Use of Antibiotic-Coated Braided Sutures in Debridement, Antibiotic, and Implant Retention (DAIR) Procedures

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prosthetic Joint Infection; Suture; Debridement With Prosthesis Retention; Prosthetic Joint Infections of Hip; Prosthetic Joint Infections of Knee
• Intervention / Treatment: Device: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial); Device: Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew R Moya, MD; Phone Number: 786-856-6463; Email: arm577@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33132
      • University of Miami Health System
      • Contact: Andrew R Moya, MD; Phone Number: 786-856-6463; Email: arm577@miami.edu
      • Principal Investigator: Colin McNamara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triclosan-Braided Suture Group; 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.	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
Active Comparator: Monofilament Suture Group; 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.	Device: Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament; Absorbable, non-braided suture. Used for fascial and skin closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with treatment failure at 90 days	Treatment failure is defined by Musculoskeletal Infection Society Criteria for prosthetic joint infection, including persistent wound drainage, sinus tract formation, positive cultures, or need for surgical revision.The proportion will be calculated as the number of patients meeting any MSIS treatment-failure criterion divided by the total number of patients evaluated. Assessment will be based on clinical evaluation and microbiological data collected at 90 days post-treatment.	90 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient)	A cost analysis will be conducted to compare the net expenses associated with the use of triclosan-coated braided absorbable sutures versus monofilament absorbable sutures for fascial and skin closure. The analysis will include direct material costs, operative time, and any postoperative complications requiring additional interventions.	Within 90 days of surgery
Incidence of Wound Dehiscence	Medical records will be reviewed for any documented wound dehiscence following surgery	Up to 90 days post-operative
Incidence of Superficial Site Infection	Medical records will be reviewed for any documented superficial surgical site infection	Up to 90 days post-operative
Incidence of Seroma Formation	Medical records will be reviewed for any documented seroma formation following surgery	Up to 90 days post-operative
Incidence of Delayed Wound Healing	Medical records will be reviewed for any documented delayed wound healing	Up to 90 days post-operative

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Colin McNamara, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: prosthetic joint infection; monofilament suture; debridement, antibiotics, implant retention; antibiotic coated braided sutures
• Other Study ID Numbers: 20250980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No