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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

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.

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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.

Conditions

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Macromastia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard of Care (SOC)

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

Group Type ACTIVE_COMPARATOR

Traditional Electrosurgery with scalpel

Intervention Type DEVICE

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

PlasmaBlade

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

Group Type EXPERIMENTAL

PEAK PlasmaBlade 4.0

Intervention Type DEVICE

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

Interventions

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PEAK PlasmaBlade 4.0

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

Intervention Type DEVICE

Traditional Electrosurgery with scalpel

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

Intervention Type DEVICE

Other Intervention Names

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PlasmaBlade Scalpel and electrosurgery SOC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No