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

NCT01284491 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-01-08

Study results available
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Summary

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.

Conditions

  • Macromastia

Interventions

DEVICE

PEAK PlasmaBlade 4.0

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

DEVICE

Traditional Electrosurgery with scalpel

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

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Abhay Gupta, MD · Gupta Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284491 on ClinicalTrials.gov