Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.
Device: PEAK PlasmaBlade
Procedure: Scalpel and Traditional Electrosurgery
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction|
- Difference in pain [ Time Frame: 24 hours and first 10 days post-op ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.
- Cutaneous scarring [ Time Frame: Up to one year post-operatively ] [ Designated as safety issue: No ]Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.
|Study Start Date:||May 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|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|
|United States, Colorado|
|Gonyon Cosmetic & Plastic Surgery, PC|
|Johnstown, Colorado, United States, 80534|
|Principal Investigator:||Denis Gonyon, MD||Gonyon Cosmetic & Plastic Surgery, PC|