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Megadyne Ace Incision/Dissection Study (ACE)

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ClinicalTrials.gov Identifier: NCT01175889
Recruitment Status : Unknown
Verified October 2012 by Megadyne Medical Products Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2010
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Megadyne ACE Incision/Dissection Study
Study Start Date : August 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

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 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



Primary Outcome Measures :
  1. Evaluate Wound Healing/Scar Formation [ Time Frame: 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 :
  1. Evaluate patient satisfaction relating to wound healing [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Megadyne Medical Products Inc.
ClinicalTrials.gov Identifier: NCT01175889     History of Changes
Other Study ID Numbers: ACE MS 1
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012