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Megadyne Ace Incision/Dissection Study (ACE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Megadyne Medical Products Inc.
ClinicalTrials.gov Identifier:
NCT01175889
First received: August 3, 2010
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Abdominoplasty
Bilateral Breast Reduction
Bilateral Breast Lift
Bilateral Brachioplasty
Bilateral Lateral Thigh and Buttocks Lift
 Device: E-Z Clean ACE Blade
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Megadyne ACE Incision/Dissection Study

Further study details as provided by Megadyne Medical Products Inc.:

Primary Outcome Measures:
  • Evaluate Wound Healing/Scar Formation [ Time Frame: 120 Days ] [ Designated as safety issue: Yes ]
    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:
  • Evaluate patient satisfaction relating to wound healing [ Time Frame: 120 Days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 52
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: ACE Blade

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175889

Locations
United States, Idaho
Center for Plastic Surgery
Twin Falls, Idaho, United States, 83301
United States, Indiana
Southwest Surgical Suites, LLC
Fort Wayne, Indiana, United States, 46804
United States, North Carolina
Plastic and Reconstructive Surgery University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Megadyne Medical Products Inc.
Investigators
Study Chair: Ryan D Lewis, M.D. Sponsor GmbH
  More Information

No publications provided

Responsible Party: Megadyne Medical Products Inc.
ClinicalTrials.gov Identifier: NCT01175889     History of Changes
Other Study ID Numbers: ACE MS 1
Study First Received: August 3, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013