NCT00986453

PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Medtronic Surgical Technologies · Industry
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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 Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery.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

Conditions

• Macromastia

Interventions

Type	Name	Description
DEVICE	PEAK PlasmaBlade	The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
PROCEDURE	Traditional Electrosurgery with scalpel	Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-09-30
• Last updated: 2013-01-01
• Results posted: 2013-01-01

Locations

7 sites across 1 country: United States