PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy (PRECISE)

This study has been terminated.
(Termination due to acquisition of PEAK Surgical by Medtronic)
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT00943605
First received: July 21, 2009
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).


Condition Intervention
Mastectomy
Device: Scalpel and Traditional Electrosurgery
Device: PEAK PlasmaBlade

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 Mastectomy

Resource links provided by NLM:


Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Total Serous Drainage (mL) From Time of Drain Placement to Removal. [ Time Frame: 0 to 10 days postoperatively ] [ Designated as safety issue: No ]
  • Area of Skin Necrosis Measured With a Standard Ruler [ Time Frame: 1 and 6 weeks postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal [ Time Frame: 0 to 10 days postoperatively ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Device: Scalpel and Traditional Electrosurgery
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
Experimental: PEAK PlasmaBlade
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Device: PEAK PlasmaBlade
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Detailed Description:

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.

This multi-site study was granted IRB approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for mastectomy with or without same day reconstruction.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943605

Locations
United States, California
Providence St. Joseph's Medical Center
Burbank, California, United States, 94505
El Camino Hospital
Mountain View, California, United States, 94040
United States, Georgia
Advanced Breast Care
Marietta, Georgia, United States, 30060
United States, Maryland
St. Joseph Medical Center
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
Principal Investigator: Teresa Ponn, MD Elliot Breast Health Center
Principal Investigator: Edward Dalton, MD Elliot Breast Health Center
Principal Investigator: Richard Fine, MD Advanced Breast Care
Principal Investigator: Peter Naruns, MD Midpeninsula Surgical Associates
Principal Investigator: Saul Eisenstat, MD Midpeninsula Surgical Associates
Principal Investigator: Michael Schultz, MD St. Joseph Medical Center
  More Information

No publications provided

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT00943605     History of Changes
Other Study ID Numbers: PEAK VP-00074
Study First Received: July 21, 2009
Results First Received: November 29, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Medtronic Surgical Technologies:
Mastectomy
PlasmaBlade
Electrosurgery
PEAK Surgical
Medtronic Advanced Energy
Medtronic

ClinicalTrials.gov processed this record on October 23, 2014