Trial Outcomes & Findings for PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy (NCT NCT00943605)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

0 to 10 days postoperatively

Results posted on

2013-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care (SOC) Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.	PEAK PlasmaBlade The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Overall Study STARTED	30	30
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	30	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care (SOC) Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.	PEAK PlasmaBlade The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Overall Study Study termination	30	30

Baseline Characteristics

PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (SOC) n=30 Participants Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.	PEAK PlasmaBlade n=30 Participants The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.	Total n=60 Participants Total of all reporting groups
Age, Customized 20 to 70 years	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 10 days postoperatively

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 and 6 weeks postoperative

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 10 days postoperatively

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

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PEAK PlasmaBlade

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care (SOC) n=30 participants at risk Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.	PEAK PlasmaBlade n=30 participants at risk The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Surgical and medical procedures Seroma	6.7% 2/30 • Number of events 2	3.3% 1/30 • Number of events 1
Surgical and medical procedures Fluid aspiration	3.3% 1/30 • Number of events 1	3.3% 1/30 • Number of events 1
Surgical and medical procedures Incision opened and resutured	3.3% 1/30 • Number of events 1	0.00% 0/30

Additional Information

Robert Swain, PhD

Medtronic Surgical Technologies

Phone: (+1-603) 294-5428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60