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| Name | Class |
|---|---|
| ConvaTec Inc. | INDUSTRY |
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The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag Surgical Dressing (treatment group) as compared to prepackaged island wound dressings consisting of traditional tape and gauze (control group) for total hip and total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (AQUACEL® Ag Surgical Dressing | Active Comparator |
| |
| Standard island gauze and tape dressing | Active Comparator | A standard island dressing consists of adhesive tape and gauze. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postop Dressing | Procedure | The AQUACEL® Ag Surgical Dressing is a silver impregnated, waterproof, adhesive dressing that sticks to the skin around the wound and blocks bacteria from the outside. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site | Wound checks will be performed during the postoperative period in the hospital followed by home healthcare providers. The final wound check will be performed by the surgeon at 4 weeks postoperatively. | 4 weeks postop |
| Measure | Description | Time Frame |
|---|---|---|
| Patient pain and satisfaction (1-100 visual analog scale) | immediate postop, 5-7 days postop, 4 weeks postop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan D Springer, MD | OrthoCarolina, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, PA | Charlotte | North Carolina | 28207 | United States |
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| Postop Dressing | Procedure | A standard island dressing consists of adhesive tape and gauze. |
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