PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction (PRECISE)

A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

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 compare these outcomes to the current standard of care (SOC).

Study Overview

• Status: Completed
• Conditions: Macromastia
• Intervention / Treatment: Device: PEAK PlasmaBlade; Procedure: Traditional Electrosurgery with scalpel

Detailed Description

Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to decrease the weight of the breasts and restructure the breast tissue for a more favorable appearance. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any excess tissue.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing bilateral breast reduction.

A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent prior to enrollment. Following enrollment, subject operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for bilateral breast reduction. Subjects were unaware of which device was used on which breast. Subjects were required to attend two follow-up visits after surgery, approximately one and six weeks following surgery.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Providence St. Joseph's
    • Glendale, California, United States, 91218
      • Verdugo Hills Hospital
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Oceanside, California, United States, 92056
      • Tri-City Medical Center
    • San Diego, California, United States, 92123
      • Sharp Outpatient Pavilion
    • San Diego, California, United States, 92128
      • Rancho Bernardo Surgery Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age between 20 and 60
2. Physically healthy, stable weight, non-smoker
3. Desiring bilateral breast reduction
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 specified follow-up evaluations.
6. Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.

Exclusion Criteria:

1. Age younger than 20 or greater than 60 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking (any kind)
4. Infection (local or systemic)
5. Cognitive impairment or mental illness
6. Severe cardiopulmonary deficiencies
7. Known coagulopathy
8. Immunocompromised
9. Prior history of breast cancer
10. Kidney disease (any type)
11. Currently taking any medication known to affect healing
12. Subjects who are status-post gastric banding or gastric bypass
13. Currently enrolled in another investigational device or drug trial
14. Unable to follow instructions or complete follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PlasmaBlade arm; The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Device: PEAK PlasmaBlade; The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.; Other Names: PlasmaBlade
ACTIVE_COMPARATOR: Standard of Care; Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.	Procedure: Traditional Electrosurgery with scalpel; Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.; Other Names: SOC; Electrosurgery; Scalpel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites. Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.	0 to 10 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood Loss		Intraoperative
Operative Time		Intraoperative
Amount of Tissue Removed		Intraoperative
Dissection Performance	Amount of tissue (g) removed over time (min)	Intraoperative

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Howard Rosenberg, MD, Accent on Aesthetics Plastic Surgery; Principal Investigator: Susan Downey, MD, Susan Downey, MD, FACS; Principal Investigator: Larry Pollack, MD, Del Mar Plastic Surgery; Principal Investigator: Hooman Soltanian, MD, University Hospital Cleveland

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: September 28, 2009
• First Submitted That Met QC Criteria: September 29, 2009
• First Posted (ESTIMATE): September 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic; Breast Reduction
• Other Study ID Numbers: PEAK VP-00065