Antibiotic-coated Braided Suture Study

NCT07322289 — Not applicable, Not yet recruiting, 142 participants, University of Miami

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

Registry	NCT07322289
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	142 (Estimated)
Sponsor	University of Miami (Other)
Conditions	Prosthetic Joint Infection, Debridement With Prosthesis Retention, Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Suture
Interventions	VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial), Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament (Device)
Dates	start 2026-11-01 (estimated), primary completion 2027-11-15 (estimated), completion 2027-12-31 (estimated), first posted 2026-01-07, last updated 2026-07-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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-Monofilament	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.

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-Monofilament (Device): Absorbable, non-braided suture. Used for fascial and skin closure.

+Outcome measures

Primary outcomes

Proportion of patients with treatment failure at 90 days [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.

Secondary outcomes

Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient) [Within 90 days of surgery]: 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.
Incidence of Wound Dehiscence [Up to 90 days post-operative]: Medical records will be reviewed for any documented wound dehiscence following surgery
Incidence of Superficial Site Infection [Up to 90 days post-operative]: Medical records will be reviewed for any documented superficial surgical site infection
Incidence of Seroma Formation [Up to 90 days post-operative]: Medical records will be reviewed for any documented seroma formation following surgery
Incidence of Delayed Wound Healing [Up to 90 days post-operative]: Medical records will be reviewed for any documented delayed wound healing

+Eligibility

Sex: All, ages: 18 Years to 89 Years

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

+Locations (1)

Facility	City	Country	Status
University of Miami Health System	Miami, Florida	United States

+Investigators

Colin McNamara, MD, Principal investigator, University of Miami