Overview

This trial is active, not recruiting.

Conditions abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift
Treatment e-z clean ace blade
Phase phase 4
Sponsor Megadyne Medical Products Inc.
Start date August 2010
End date December 2012
Trial size 52 participants
Trial identifier NCT01175889, ACE MS 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
e-z clean ace blade 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.
(Active Comparator)
e-z clean ace blade 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.

Primary Outcomes

Measure
Evaluate Wound Healing/Scar Formation
time frame: 120 Days

Secondary Outcomes

Measure
Evaluate patient satisfaction relating to wound healing
time frame: 120 Days

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Megadyne ACE Incision/Dissection Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Megadyne Medical Products Inc..