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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Gonyon Cosmetic & Plastic Surgery, PC
Johnstown, Colorado, United States
Difference in pain
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.
Time frame: 24 hours and first 10 days post-op
Operative performance
Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.
Time frame: Intraoperatively on day 0
Adverse events
Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.
Time frame: 1 month post-operatively
Cutaneous scarring
Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.
Time frame: Up to one year post-operatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.