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

January 3, 2013 updated by: Medtronic Surgical Technologies

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92131
        • Gupta Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care (SOC)
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Device: Traditional Electrosurgery with scalpel
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Other Names:
  • Scalpel and electrosurgery
  • SOC
Experimental: PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
Device: PEAK PlasmaBlade 4.0
The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
Other Names:
  • PlasmaBlade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Quality
Time Frame: 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.
0-18 months following breast reduction surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Surgical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEAK VP-00070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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