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This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acute PJI in the 90 days following total hip and knee revision arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgiphor: sterile povidone iodine irrigation solution | Active Comparator | Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS |
|
| Sterile saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgiphor Irrigation Solution | Device | use of Surgiphor wound irrigation solution during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of acute prosthetic joint infection | Diagnosis of acute prothetic joint infection following aseptic revision surgery | Within 90 days of revision surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | Diagnosis of wound complication, surgical site infections or other infections within 1 year of surgery | within 1 year of revision surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Phoenix | Arizona | 85724 | United States | ||
| Lifebridge Health |
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| Sterile saline | Device | Use of sterile saline as a irrigation solution during surgery |
|
| Baltimore |
| Maryland |
| 21215 |
| United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Rothman Institute Orthopaedics | Philadelphia | Pennsylvania | 19107 | United States |