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The Megadyne Aceâ„¢ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one side ACE blade | Experimental |
| |
| one side scalpel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Z Clean ACE Blade | Device | The prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Wound Healing/Scar Formation | Primary Effectiveness Objective Evaluate wound healing/ scar formation between incisions made using a cold steel scalpel and incisions made using the ACE Blade per photographic evidence at 120 days by an independent observer | 120 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate patient satisfaction relating to wound healing | Secondary Effectiveness Objective Evaluate patient satisfaction relating to wound healing/ scar formation between incisions made using a cold steel scalpel and incisions made using the ACE Blade at 120 days | 120 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan D Lewis, M.D. | Sponsor GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Plastic Surgery | Twin Falls | Idaho | 83301 | United States | ||
| Southwest Surgical Suites, LLC |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 23, 2013 | |
| Reset | Dec 12, 2013 | |
| Release | Apr 16, 2014 | |
| Reset | May 14, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 23, 2013 | Dec 12, 2013 | |||
| Apr 16, 2014 |
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|
|
| Fort Wayne |
| Indiana |
| 46804 |
| United States |
| Plastic and Reconstructive Surgery University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| May 14, 2014 |