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

Medtronic

Status: Terminated

Conditions: Macromastia

Treatments: Device: Traditional Electrosurgery with scalpel; Device: PEAK PlasmaBlade 4.0

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284491

PEAK VP-00070

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

Device: Traditional Electrosurgery with scalpel

PlasmaBlade

Experimental group

Description:

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

Treatment:

Device: PEAK PlasmaBlade 4.0