PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

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 Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery.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

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

Conditions
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Macromastia

Intervention / Treatment
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* Device: PEAK PlasmaBlade
* Procedure: Traditional Electrosurgery with scalpel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 60 Physically healthy, stable weight, non-smoker Desiring bilateral breast reduction Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. Subject must be willing and able to comply with specified follow-up evaluations. 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: Age younger than 20 or greater than 60 years old Anticoagulation therapy which cannot be discontinued Smoking (any kind) Infection (local or systemic) Cognitive impairment or mental illness Severe cardiopulmonary deficiencies Known coagulopathy Immunocompromised Prior history of breast cancer Kidney disease (any type) Currently taking any medication known to affect healing Subjects who are status-post gastric banding or gastric bypass Currently enrolled in another investigational device or drug trial Unable to follow instructions or complete follow-up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlasmaBlade arm<br>The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision. | Device: PEAK PlasmaBlade<br>* The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.<br>* Other names: PlasmaBlade;|
| Active Comparator: Standard of Care<br>Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | Procedure: Traditional Electrosurgery with scalpel<br>* Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.<br>* Other names: SOC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Reduction, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic