PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Not Applicable

Completed

• Conditions: Macromastia
• Interventions: Device: PEAK PlasmaBlade; Procedure: Traditional Electrosurgery with scalpel

• Registration Number: NCT00986453
• Lead Sponsor: Medtronic Surgical Technologies

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 Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery.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

Study Timeline

• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2010-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-11
• Results First Submitted: 2012-11-29
• Results First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Results First Posted: 2013-01-01
• Last Update Posted: 2013-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PlasmaBlade arm	PEAK PlasmaBlade	The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
Standard of Care	Traditional Electrosurgery with scalpel	Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	0 to 10 days postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Blood Loss	Intraoperative
Operative Time	Intraoperative
Amount of Tissue Removed	Intraoperative
Dissection Performance	Intraoperative	Amount of tissue (g) removed over time (min)

Trial Locations

Locations (7)

Verdugo Hills Hospital; 🇺🇸 Glendale, California, United States

Providence St. Joseph's; 🇺🇸 Burbank, California, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Tri-City Medical Center; 🇺🇸 Oceanside, California, United States

Sharp Outpatient Pavilion; 🇺🇸 San Diego, California, United States

University Hospitals; 🇺🇸 Cleveland, Ohio, United States

Rancho Bernardo Surgery Center; 🇺🇸 San Diego, California, United States