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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
United States1 site
University of Miami Health System
Miami, Florida, 33132
Andrew R Moya, MD, 786-856-6463, arm577@miami.edu
Colin McNamara, MD
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin A. McNamara, University of Miami
- Investigators
- Colin McNamara, MD, Principal investigator, University of Miami
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Antibiotic-Coated Braided Sutures in Debridement, Antibiotic, and Implant Retention (DAIR) Procedures
- ClinicalTrials.gov ID
- NCT07322289
- Acronym / sponsor ID
- 20250980
- Conditions
- Prosthetic Joint Infection, Debridement With Prosthesis Retention, Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Suture
- Keywords
- prosthetic joint infection, debridement, antibiotics, implant retention, antibiotic coated braided sutures, monofilament suture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triclosan-Braided Suture Group | Experimental | Device: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)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. |
| Monofilament Suture Group | Active comparator | Device: Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-MonofilamentPatients 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Triclosan-Braided Suture Group |
| Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-MonofilamentAbsorbable, non-braided suture. Used for fascial and skin closure. | Device | Monofilament Suture Group |
Primary outcome
Proportion of patients with treatment failure at 90 days
Time frame: 90 days post treatment
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.
5 secondary outcomes
Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient)
Time frame: Within 90 days of surgery
Incidence of Wound Dehiscence
Time frame: Up to 90 days post-operative
Incidence of Superficial Site Infection
Time frame: Up to 90 days post-operative
Incidence of Seroma Formation
Time frame: Up to 90 days post-operative
Incidence of Delayed Wound Healing
Time frame: Up to 90 days post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin McNamara, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew R Moya, MD (786-856-6463, arm577@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with treatment failure at 90 days (time frame: 90 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.