Megadyne Ace Incision/Dissection Study
ACE
Megadyne ACE Incision/Dissection Study
1 other identifier
interventional
52
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 3, 2010
CompletedFirst Posted
Study publicly available on registry
August 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 25, 2012
October 1, 2012
2.3 years
August 3, 2010
October 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluate patient satisfaction relating to wound healing
120 Days
Study Arms (2)
one side ACE blade
EXPERIMENTALone side scalpel
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Center for Plastic Surgery
Twin Falls, Idaho, 83301, United States
Southwest Surgical Suites, LLC
Fort Wayne, Indiana, 46804, United States
Plastic and Reconstructive Surgery University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Study Officials
- STUDY CHAIR
Ryan D Lewis, M.D.
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2010
First Posted
August 5, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 25, 2012
Record last verified: 2012-10