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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triclosan-Braided Suture Group | Experimental | 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. |
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| Monofilament Suture Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Acute Prosthetic Joint Infection: <4 weeks since it was suspected/diagnosed
Exclusion Criteria:
neutropenia, HIV, steroid use
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew R Moya, MD | Contact | 786-856-6463 | arm577@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colin McNamara, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Health System | Miami | Florida | 33132 | United States |
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| Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament | Device | Absorbable, non-braided suture. Used for fascial and skin closure. |
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| Within 90 days of surgery |
| Incidence of Wound Dehiscence | Medical records will be reviewed for any documented wound dehiscence following surgery | Up to 90 days post-operative |
| Incidence of Superficial Site Infection | Medical records will be reviewed for any documented superficial surgical site infection | Up to 90 days post-operative |
| Incidence of Seroma Formation | Medical records will be reviewed for any documented seroma formation following surgery | Up to 90 days post-operative |
| Incidence of Delayed Wound Healing | Medical records will be reviewed for any documented delayed wound healing | Up to 90 days post-operative |