Abdominoplasty Clinical Trial
— ACEOfficial title:
Megadyne ACE Incision/Dissection Study
Verified date | October 2012 |
Source | Megadyne Medical Products Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Megadyne Ace™ 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.
Status | Unknown status |
Enrollment | 52 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Subject is >18 years of age or < 60 years old - Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof - Subject is able to discontinue anticoagulant therapy (including Aspirin) - Subject is willing and able to comply with study follow-up procedures - Subject is willing to provide written informed consent for their participation in the study Exclusion Criteria: - Subject has a history of smoking in the last 6 months prior to surgery. - Subject has a history of type I or type II Diabetes. - Subject has an active infection of any kind at the time of enrollment - Subject has a known coagulopathy |
Country | Name | City | State |
---|---|---|---|
United States | Southwest Surgical Suites, LLC | Fort Wayne | Indiana |
United States | Center for Plastic Surgery | Twin Falls | Idaho |
United States | Plastic and Reconstructive Surgery University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Megadyne Medical Products Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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