Megadyne Ace Incision/Dissection Study

Study Overview
=================
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.

Official Title
-----------------
Megadyne ACE Incision/Dissection Study

Conditions
-----------------
Abdominoplasty, Bilateral Breast Reduction, Bilateral Breast Lift, Bilateral Brachioplasty, Bilateral Lateral Thigh and Buttocks Lift

Intervention / Treatment
-----------------
* Device: E-Z Clean ACE Blade


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one side ACE blade<br> | Device: E-Z Clean ACE Blade<br>* 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.<br>* Other names: ACE Blade;|
| Active Comparator: one side scalpel<br> | Device: E-Z Clean ACE Blade<br>* 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.<br>* Other names: ACE Blade;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |