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

Medtronic Surgical Technologies13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Macromastia

Interventions

PEAK PlasmaBlade 4.0DEVICE

The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.

Traditional Electrosurgery with scalpelDEVICE

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 70 2. Physically healthy, stable weight 3. Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery. 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. Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study. Exclusion Criteria: 1. Age younger than 18 or greater than 70 years old 2. Anticoagulation therapy which cannot be discontinued 3. Smoking (continuous; any substance) 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 did not participated in the PEAK PlasmaBlade bilateral breast reduction study 13. Unable to follow instructions or complete follow-up

Locations (1)

Gupta Plastic Surgery

San Diego, California, United States

Outcomes

Primary Outcomes

Scar Quality

The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.

Time frame: 0-18 months following breast reduction surgery

Data from ClinicalTrials.gov

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