Prosthetic Joint InfectionNCT07322289

Antibiotic-coated Braided Suture Study

A study testing VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial) and Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament in people with Prosthetic Joint Infection and Debridement With Prosthesis Retention, run by University of Miami at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Prosthetic Joint Infection, Debridement With Prosthesis Retention, Prosthetic Joint Infections of Hip
What is being tested?: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial) and Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2026to 31 Dec 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Allergy to Triclosan
Pregnancy
Prisoners

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew R Moya, MD contact

786-856-6463

arm577@miami.edu

United States1 site

University of Miami Health System
Miami, Florida, 33132
Andrew R Moya, MD, 786-856-6463, arm577@miami.edu
Colin McNamara, MD

Other trials in United States

About this study

Official title: 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.

Conditions: Prosthetic Joint Infection, Debridement With Prosthesis Retention, Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Suture
Being tested: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial), Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament
Keywords: prosthetic joint infection, debridement, antibiotics, implant retention, antibiotic coated braided sutures, monofilament suture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)Device
Synthetic, absorbable, braided suture coated with triclosan for antimicrobial protection. Used for fascial and skin closure. Offers high tensile strength and knot security
Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-MonofilamentDevice
Absorbable, non-braided suture. Used for fascial and skin closure.

Study groups in NCT07322289
Study group	Role	What they receive
Triclosan-Braided Suture Group	Experimental	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. Receives: Device: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)
Monofilament Suture Group	Active comparator	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. Receives: Device: Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 90 days post treatment

Secondary outcomes (5)

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.
Measured: Within 90 days of surgery
Incidence of Wound Dehiscence
Medical records will be reviewed for any documented wound dehiscence following surgery
Measured: Up to 90 days post-operative
Incidence of Superficial Site Infection
Medical records will be reviewed for any documented superficial surgical site infection
Measured: Up to 90 days post-operative
Incidence of Seroma Formation
Medical records will be reviewed for any documented seroma formation following surgery
Measured: Up to 90 days post-operative
Incidence of Delayed Wound Healing
Medical records will be reviewed for any documented delayed wound healing
Measured: Up to 90 days post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202631 Dec 2027

First posted7 Jan 2026
Study start1 Nov 2026 (estimated)
Primary completion15 Nov 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 142 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07322289
Sponsor's protocol ID: 20250980
Status last verified: Mar 2026
First submitted: 5 Jan 2026
Last updated: 8 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

Andrew R Moya, MD

786-856-6463

arm577@miami.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Arthroplasty, Arthroplasty Replacement, Knee
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
Recruiting
Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
Prosthetic Joint Infection (PJI)
Not yet recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee

All Prosthetic Joint Infection trials