Megadyne Ace Incision/Dissection Study

Abdominoplasty Clinical Trial

— ACE  

Official title:

Megadyne ACE Incision/Dissection Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01175889
• Other study ID #: ACE MS 1
• 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
• 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

Related Conditions & MeSH terms

• Abdominoplasty
• Bilateral Brachioplasty
• Bilateral Breast Lift
• Bilateral Breast Reduction
• Bilateral Lateral Thigh and Buttocks Lift

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