Megadyne Ace Incision/Dissection Study (ACE)

Megadyne ACE Incision/Dissection Study

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.

Study Overview

• Status: Unknown
• Conditions: Abdominoplasty; Bilateral Breast Reduction; Bilateral Breast Lift; Bilateral Brachioplasty; Bilateral Lateral Thigh and Buttocks Lift
• Intervention / Treatment: Device: E-Z Clean ACE Blade

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Twin Falls, Idaho, United States, 83301
      • Center for Plastic Surgery
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Southwest Surgical Suites, LLC
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Plastic and Reconstructive Surgery University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one side ACE blade	Device: E-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.; Other Names: ACE Blade
Active Comparator: one side scalpel	Device: E-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.; 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

Collaborators and Investigators

• Sponsor: Megadyne Medical Products Inc.
• Investigators: Study Chair: Ryan D Lewis, M.D., Sponsor GmbH

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: ACE MS 1