Megadyne Ace Incision/Dissection Study

Phase 4

• Conditions: Bilateral Breast Lift; Bilateral Brachioplasty; Bilateral Lateral Thigh and Buttocks Lift; Abdominoplasty; Bilateral Breast Reduction
• Interventions: Device: E-Z Clean ACE Blade

• Registration Number: NCT01175889
• Lead Sponsor: Megadyne Medical Products Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one side scalpel	E-Z Clean ACE Blade	-
one side ACE blade	E-Z Clean ACE Blade	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Center for Plastic Surgery; 🇺🇸 Twin Falls, Idaho, United States

Southwest Surgical Suites, LLC; 🇺🇸 Fort Wayne, Indiana, United States

Plastic and Reconstructive Surgery University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States