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

Stopped early · Not applicable

Conditions studied: Macromastia

In brief

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.

Key facts

Study ID: NCT01284491
Run by: Medtronic Surgical Technologies
People needed: 13
Starts: 2011-01-01
Expected to finish: 2012-05-01
Last updated by the study team: 2013-01-08

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Gupta Plastic Surgery — San Diego, California, United States

Full record on ClinicalTrials.gov

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