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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
142
Synthetic, absorbable, braided suture coated with triclosan for antimicrobial protection. Used for fascial and skin closure. Offers high tensile strength and knot security
Absorbable, non-braided suture. Used for fascial and skin closure.
University of Miami Health System
Miami, Florida, United States
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
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
Incidence of Wound Dehiscence
Medical records will be reviewed for any documented wound dehiscence following surgery
Time frame: Up to 90 days post-operative
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
Incidence of Seroma Formation
Medical records will be reviewed for any documented seroma formation following surgery
Time frame: Up to 90 days post-operative
Incidence of Delayed Wound Healing
Medical records will be reviewed for any documented delayed wound healing
Time frame: Up to 90 days post-operative
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