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

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.

• PEAK PlasmaBlade 4.0 (Device), also known as PlasmaBlade: The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
• Traditional Electrosurgery with scalpel (Device), also known as Scalpel and electrosurgery, SOC: Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Primary outcomes

• Scar Quality [0-18 months following breast reduction surgery]: The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.

Sex: Female, ages: 18 Years to 70 Years

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

Participant flow

Outcome results

• Scar Quality (Primary)

Adverse events

Limitations and caveats: Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.

• Abhay Gupta, MD, Principal investigator, Gupta Plastic Surgery