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

This study has been terminated.
(Termination due to acquisition of PEAK Surgical by Medtronic)
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT01284491
First received: January 25, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Macromastia
 Device: PEAK PlasmaBlade 4.0
Device: Traditional Electrosurgery with scalpel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Scar Quality [ Time Frame: 0-18 months following breast reduction surgery ] [ Designated as safety issue: No ]
    The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.


Enrollment: 13
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PlasmaBlade

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284491

Locations
United States, California
Gupta Plastic Surgery
San Diego, California, United States, 92131
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
Principal Investigator: Abhay Gupta, MD Gupta Plastic Surgery
  More Information

No publications provided

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT01284491     History of Changes
Other Study ID Numbers: PEAK VP-00070
Study First Received: January 25, 2011
Results First Received: November 29, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Surgical Technologies:
Breast reduction
PlasmaBlade
Electrosurgery
 PEAK Surgical
Medtronic Advanced Energy
Medtronic

ClinicalTrials.gov processed this record on May 16, 2013