A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0

Study Overview
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Brief Summary
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The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.

Detailed Description
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Subjects attended one of two evaluation dates scheduled on January 21, 2011 and February 23, 2011. During this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the Patient Scar Assessment Scale. Following subjects' self-evaluation, each subject was evaluated by three evaluators using the Observer Scar Assessment Scale.

Official Title
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A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0

Conditions
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Macromastia

Intervention / Treatment
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* Device: PEAK PlasmaBlade 4.0
* Device: Traditional Electrosurgery with scalpel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70 Physically healthy, stable weight Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery. 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. Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study. Exclusion Criteria: Age younger than 18 or greater than 70 years old Anticoagulation therapy which cannot be discontinued Smoking (continuous; any substance) 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 did not participated in the PEAK PlasmaBlade bilateral breast reduction study Unable to follow instructions or complete follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care (SOC)<br>Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | Device: Traditional Electrosurgery with scalpel<br>* Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.<br>* Other names: SOC;|
| Experimental: PlasmaBlade<br>The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision. | Device: PEAK PlasmaBlade 4.0<br>* The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.<br>* Other names: PlasmaBlade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Quality | The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions. | 0-18 months following breast reduction surgery | 

 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