Clinical trial NCT00986453: PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Official title: A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macromastia
Keywords: Breast Reduction
PlasmaBlade
Electrosurgery
PEAK Surgical
Medtronic Advanced Energy
Medtronic
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery.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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 0 to 10 days postoperative
Secondary outcomes:
measure: Estimated Blood Loss
timeFrame: Intraoperative
measure: Operative Time
timeFrame: Intraoperative
measure: Amount of Tissue Removed
timeFrame: Intraoperative
measure: Dissection Performance
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence St. Joseph's
state: California
city: Glendale
country: United States
facility: Verdugo Hills Hospital
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Oceanside
country: United States
facility: Tri-City Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Outpatient Pavilion
state: California
city: San Diego
country: United States
facility: Rancho Bernardo Surgery Center
state: California
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: Gupta Plastic Surgery
name: Abhay Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Accent on Aesthetics Plastic Surgery
name: Howard Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Susan Downey, MD, FACS
name: Susan Downey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Del Mar Plastic Surgery
name: Larry Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Cleveland
name: Hooman Soltanian, MD
role: PRINCIPAL_INVESTIGATOR
References: