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Not yet recruiting NCT07322289

Antibiotic-coated Braided Suture Study

No phase Interventional Prosthetic Joint Infection Debridement With Prosthesis Retention Prosthetic Joint Infections of Hip Prosthetic Joint Infections of Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial), Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament.
Who it may be relevant to
Registry conditions: Prosthetic Joint Infection, Debridement With Prosthesis Retention, Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Proportion of patients with treatment failure at 90 days [Time frame: 90 days post treatment]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami Health System — Miami

Identifiers

NCT: NCT07322289 · 20250980

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗