Antibiotic-coated Braided Suture Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Staphylococcus aureus bacteremia

Mycobacterial, fungal, or parasitic infection

Concurrent infection needing prolonged Intravenous therapy

Septic shock/systemic illness needing IV therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Triclosan-Braided Suture GroupExperimental treatment 1 intervention
Group B: Monofilament Suture GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days post treatment

Secondary outcomes

1

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.

Time frame
Within 90 days of surgery
2

Incidence of Wound Dehiscence

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

Time frame
Up to 90 days post-operative
3

Incidence of Superficial Site Infection

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

Time frame
Up to 90 days post-operative
4

Incidence of Seroma Formation

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

Time frame
Up to 90 days post-operative

Other outcomes

Sponsors and contacts

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