Debridement With Prosthesis Retention, Prosthetic Joint Infection, Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Suture
Conditions
Keywords
prosthetic joint infection, debridement, antibiotics, implant retention, antibiotic coated braided sutures, monofilament suture
Brief summary
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
DEVICEVICRYL™ 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
DEVICEPolydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament
Absorbable, non-braided suture. Used for fascial and skin closure.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with treatment failure at 90 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient) | 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. |
| Incidence of Wound Dehiscence | Up to 90 days post-operative | Medical records will be reviewed for any documented wound dehiscence following surgery |
| Incidence of Superficial Site Infection | Up to 90 days post-operative | Medical records will be reviewed for any documented superficial surgical site infection |
| Incidence of Seroma Formation | Up to 90 days post-operative | Medical records will be reviewed for any documented seroma formation following surgery |
| Incidence of Delayed Wound Healing | Up to 90 days post-operative | Medical records will be reviewed for any documented delayed wound healing |
Countries
United States
Contacts
CONTACTAndrew R Moya, MD
PRINCIPAL_INVESTIGATORColin McNamara, MD
University of Miami
Outcome results
None listed