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A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy


N/A
20 Years
70 Years
Open (Enrolling)
Female
Mastectomy

Thank you

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 CenterTowson, Maryland  21204
El Camino HospitalMountain View, California  94040
Provident St. Joseph's Medical CenterBurbank, California  94505
Advanced Breast CareMarietta, Georgia  30060