A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer,
or has a high probability of containing cancer. During the procedure, a scalpel is used for
the skin incision and a traditional electrosurgical device is used to cut away the breast
tissue from the chest and control bleeding. Once the breast tissue is removed the remaining
skin edges are brought together with sutures.
Following mastectomy, the most common complication is persistent serous wound drainage and
seroma, a collection of fluid in the closed surgical space. To help prevent this
complication a tissue drain is used to remove serous fluid from the surgical space via bulb
suction. The rate of serous fluid collection is used to determine the time the drain remains
in place. Although suction drains help reduce seroma formation, prolonged use may delay
healing, cause injury, and increase the risk of infection and patient discomfort.
The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and
coagulating at the point of application, without the thermal damage to surrounding tissues
that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA
clearance for use in plastic, general, and ENT surgery, and has demonstrated significantly
reduced serous drainage in tissue reduction surgeries, like mastectomy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Total serous drainage (mL) from time of drain placement to removal.
First 10 Post-operative days
Teresa Ponn, MD
Elliot Breast Health Center
United States: Institutional Review Board
|St. Joseph Medical Center||Towson, Maryland 21204|
|El Camino Hospital||Mountain View, California 94040|
|Provident St. Joseph's Medical Center||Burbank, California 94505|
|Advanced Breast Care||Marietta, Georgia 30060|