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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.
Participating subjects will be randomized to one of the study groups: Group 1 (Control group) or Group 2 (Treatment group). If randomized to Group 1- after surgery, the doctor will apply the standard non-stick gauze dressing to the wound. If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound.
The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Control group) | Active Comparator | Surgical wound will be covered with the standard non-stick gauze dressing. |
|
| Group 2 (Treatment group) | Experimental | Surgical wound will be covered with the PICO dressing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-stick gauze dressing | Other | Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing |
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| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | To determine presence or absence of wound complications at the follow-up visits. | Approximately 12-weeks after surgery (or until 3-month postop visit is completed) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Loveland | Contact | 301-560-2937 | amy.loveland@medstar.net | |
| Crisanto Macaraeg | Contact | 410-261-8218 | Crisanto.L.Macaraeg@Medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Walter C Hembree, MD | MedStar Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amy Loveland | Recruiting | Baltimore | Maryland | 21218 | United States |
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| PICO dressing | Device | Group 2 (Treatment group): surgical site will be dressed with PICO dressing |
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