NCT01284491

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 3, 2013

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

January 25, 2011

Results QC Date

November 29, 2012

Last Update Submit

January 3, 2013

Conditions

Macromastia

Keywords

Breast reductionPlasmaBladeElectrosurgeryPEAK SurgicalMedtronic Advanced EnergyMedtronic

Outcome Measures

Primary Outcomes (1)

  • Scar Quality

    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

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

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

Device: Traditional Electrosurgery with scalpel

PlasmaBlade

EXPERIMENTAL

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

Device: PEAK PlasmaBlade 4.0

Interventions

PEAK PlasmaBlade 4.0DEVICE

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

Also known as: PlasmaBlade
PlasmaBlade
Traditional Electrosurgery with scalpelDEVICE

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

Also known as: Scalpel and electrosurgery, SOC
Standard of Care (SOC)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gupta Plastic Surgery

San Diego, California, 92131, United States

Location

MeSH Terms

Conditions

GigantomastiaHyperthermia

Interventions

Electrosurgery

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.

Results Point of Contact

Title
Robert Swain, PhD
Organization
Medtronic Surgical Technologies
robert.e.swain@medtronic.com
(+1-603) 294-5428

Study Officials

  • Abhay Gupta, MD

    Gupta Plastic Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 8, 2013

Results First Posted

January 3, 2013

Record last verified: 2013-01

Locations

US(1)