Antibiotic-coated Braided Suture Study

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Mar 2026

Primary completion

Jul 15, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

142 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Triclosan-Braided Suture Group
  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.
• Active Comparator: Monofilament Suture Group
  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.

Primary Outcome Measure

Proportion of patients with treatment failure at 90 days [ Time Frame: 90 days post treatment ]

Central Contacts

• Andrew R Moya, MD
  786-856-6463
  [email protected]

Locations (1)

Find similar trials in Miami, FL

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