Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
|ClinicalTrials.gov Identifier: NCT01404351|
Recruitment Status : Withdrawn (Study terminated due to the acquisition of PEAK Surgical by Medtronic)
First Posted : July 28, 2011
Last Update Posted : January 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Macromastia (Symptomatic)||Device: PEAK PlasmaBlade Procedure: Scalpel and Traditional Electrosurgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||November 2011|
|Experimental: PEAK PlasmaBlade||Device: PEAK PlasmaBlade|
Active Comparator: Standard of Care
The Standard of Care arm will consist of the scalpel for the skin incision and traditional electrosurgery for subcutaneous dissection.
|Procedure: Scalpel and Traditional Electrosurgery|
- Difference in pain [ Time Frame: 24 hours and first 10 days post-op ]The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily.
- Operative performance [ Time Frame: Intraoperatively on day 0 ]Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.
- Adverse events [ Time Frame: 1 month post-operatively ]Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.
- Cutaneous scarring [ Time Frame: Up to one year post-operatively ]Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404351
|United States, Colorado|
|Gonyon Cosmetic & Plastic Surgery, PC|
|Johnstown, Colorado, United States, 80534|
|Principal Investigator:||Denis Gonyon, MD||Gonyon Cosmetic & Plastic Surgery, PC|