A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
20 Years
70 Years
Female
Mastectomy
Trial Information
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.
Inclusion Criteria:
1. Age between 20 and 70 years old
2. Physically healthy, stable weight
3. Requiring single or bilateral simple mastectomy, with or without sentinel lymph node
biopsy
4. Subject must understand the nature of the procedure and provide written informed
consent prior to the procedure
5. Subject must be willing and able to comply with all follow-up evaluations
Exclusion Criteria:
1. Age younger than 20 or greater than 70 years old
2. Anticoagulation therapy which cannot be discontinued
3. Prior external beam or implanted radiotherapy
4. Tobacco use (any kind)
5. Infection (local or systemic)
6. Cognitive impairment or mental illness
7. Severe cardiopulmonary deficiencies
8. Known coagulopathy
9. Immunocompromised
10. Kidney disease (any type)
11. Desiring or requiring same-day breast reconstruction
12. Prior breast reduction or augmentation surgery
13. Unable to follow instructions or complete follow-up
14. Currently taking any medication known to affect healing
15. Subjects who are status-post gastric banding or gastric bypass
16. Currently enrolled in another investigational device or drug trial
17. Time from most recent neoadjuvant therapy less than 4 weeks
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Total serous drainage (mL) from time of drain placement to removal.
Outcome Time Frame:
First 10 Post-operative days
Safety Issue:
No
Principal Investigator
Teresa Ponn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Elliot Breast Health Center
Authority:
United States: Institutional Review Board
Study ID:
PEAK VP-00074
NCT ID:
NCT00943605
Start Date:
May 2009
Completion Date:
January 2012
Related Keywords:
- Mastectomy
- Mastectomy
- Electrosurgery
- Electrocautery
- Cancer
- Seroma
- Plasma
Name | Location |
|---|---|
| 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 |
