Megadyne Ace Incision/Dissection Study (ACE)

Megadyne Medical Products

Status and phase: Unknown; Phase 4

Conditions: Bilateral Brachioplasty; Bilateral Breast Reduction; Bilateral Lateral Thigh and Buttocks Lift; Abdominoplasty; Bilateral Breast Lift

Treatments: Device: E-Z Clean ACE Blade

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175889

ACE MS 1

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

52 participants in 2 patient groups

one side ACE blade

Experimental group

Treatment:

Device: E-Z Clean ACE Blade

one side scalpel

Active Comparator group

Treatment:

Device: E-Z Clean ACE Blade