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Change in research plan
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Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zip Surgical Skin Closure | Active Comparator | Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples |
|
| Steel Staples | Active Comparator | Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zip Surgical Skin Closure | Device | Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Outcome - Wound Healing | Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments. | 6 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Satisfaction with the Closure Method | Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) | At Discharge, 1-3 days post surgery |
| Patient Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Storne | VP Marketing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Research Foundation | Indianapolis | Indiana | 46278 | United States |
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| Steel Staples | Device | Skin Closure device for the closure of the skin layer for surgical incisions. |
|
General post operative and incisional pain levels will be collected using a 10 point VAS scale
| Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.) |
| Patient Satisfaction of Scars | Scar satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) and with a 10 point VAS scale | At 6 week Follow up (exit) visit |