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The intent of this study is to evaluate the Prevena â„¢ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| There is one group of 100 patients | Other | 50 of these patients will receive a total hip replacement; 50 patients will receive a total knee replacement; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Incisional Management System | Device | All evaluable patients will utilize the Prevena Incisional Management System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative pressure environment with accurate and reliable indicators;Dressing biocompatible with incision site and skin;Minimal dressing changes during therapy;Acceptable safety profile; minimal/no AEs;Patient comfort and dressing integrity after surgery | during hospitalization (up to 7 days) and thru follow-up 30 days after dressing removal |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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