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NCT Number: NCT07322289

Antibiotic-coated Braided Suture Study

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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Key information

Conditions

Prosthetic Joint Infection Debridement With Prosthesis Retention Prosthetic Joint Infections of Hip Prosthetic Joint Infections of Knee Suture

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Health System

Miami, Florida, 33132, United States

Location contact

Andrew R Moya, MD

CONTACT

[email protected]

786-856-6463

Colin McNamara, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient)

    Time frame: 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.

  2. Incidence of Wound Dehiscence

    Time frame: Up to 90 days post-operative

    Medical records will be reviewed for any documented wound dehiscence following surgery

  3. Incidence of Superficial Site Infection

    Time frame: Up to 90 days post-operative

    Medical records will be reviewed for any documented superficial surgical site infection

  4. Incidence of Seroma Formation

    Time frame: Up to 90 days post-operative

    Medical records will be reviewed for any documented seroma formation following surgery

  5. Incidence of Delayed Wound Healing

    Time frame: Up to 90 days post-operative

    Medical records will be reviewed for any documented delayed wound healing

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew R Moya, MD

CONTACT

[email protected]

786-856-6463

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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