Megadyne Ace Incision/Dissection Study
This trial is active, not recruiting.
|Conditions||abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift|
|Treatment||e-z clean ace blade|
|Sponsor||Megadyne Medical Products Inc.|
|Start date||August 2010|
|End date||December 2012|
|Trial size||52 participants|
|Trial identifier||NCT01175889, ACE MS 1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Twin Falls, ID||Center for Plastic Surgery||no longer recruiting|
|Fort Wayne, IN||Southwest Surgical Suites, LLC||no longer recruiting|
|Winston-Salem, NC||Plastic and Reconstructive Surgery University Health Sciences||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
Evaluate Wound Healing/Scar Formation
time frame: 120 Days
Evaluate patient satisfaction relating to wound healing
time frame: 120 Days
Male or female participants from 18 years up to 60 years old.
- 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
- 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
|Official title||Megadyne ACE Incision/Dissection Study|
Call for more information