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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01175889
Other study ID # ACE MS 1
Secondary ID
Status Unknown status
Phase Phase 4
First received August 3, 2010
Last updated October 24, 2012
Start date August 2010
Est. completion date December 2012

Study information

Verified date October 2012
Source Megadyne Medical Products Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Unknown status
Enrollment 52
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Southwest Surgical Suites, LLC Fort Wayne Indiana
United States Center for Plastic Surgery Twin Falls Idaho
United States Plastic and Reconstructive Surgery University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Megadyne Medical Products Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Evaluate patient satisfaction relating to wound healing 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 120 Days
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