Abdominoplasty, Bilateral Brachioplasty, Bilateral Breast Lift, Bilateral Breast Reduction, Bilateral Lateral Thigh and Buttocks Lift
Conditions
Brief summary
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.
Interventions
DEVICEE-Z Clean ACE Blade
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.
Sponsors
Megadyne Medical Products Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Wound Healing/Scar Formation | 120 Days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate patient satisfaction relating to wound healing | 120 Days | 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 |
Countries
United States
Outcome results
None listed