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Megadyne Ace Incision/Dissection Study (ACE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Megadyne Medical Products Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175889
First Posted: August 5, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Megadyne Medical Products Inc.
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Megadyne Medical Products Inc.
ClinicalTrials.gov Identifier: NCT01175889     History of Changes
Other Study ID Numbers: ACE MS 1
First Submitted: August 3, 2010
First Posted: August 5, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2012