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Trial Outcomes & Findings for A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0 (NCT NCT01284491)

NCT ID: NCT01284491

Last Updated: 2013-01-08

Results Overview

The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

0-18 months following breast reduction surgery

Results posted on

2013-01-08

Participant Flow

Subjects' breasts were randomized individually to the PEAK PlasmaBlade or SOC group.

Participant milestones

Participant milestones
Measure
Total Study Population
Overall Study
STARTED
13
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
13

Reasons for withdrawal

Reasons for withdrawal
Measure
Total Study Population
Overall Study
Study termination
13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Study Population
n=13 Participants
Age, Customized
18 to 70 years
13 participants
n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
13 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0-18 months following breast reduction surgery

Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.

The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.

Outcome measures

Outcome data not reported

Adverse Events

PEAK PlasmaBlade 4.0

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Traditional Electrosurgery With Scalpel

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Swain, PhD

Medtronic Surgical Technologies

Phone: (+1-603) 294-5428

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60