Trial Outcomes & Findings for PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction (NCT NCT00986453)

NCT ID: NCT00986453

Last Updated: 2013-01-01

Results Overview

The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites. Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 0 to 10 days postoperative
• Results posted on: 2013-01-01

Participant Flow

Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.

Participant milestones

Measure	Total Study Population Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
Overall Study STARTED	45
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Baseline characteristics by cohort

Measure	Total Study Population n=45 Participants Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
Age Continuous	41.12 years STANDARD_DEVIATION 14.20 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 10 days postoperative

Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.

The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.

Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.

Outcome measures

Measure	PEAK PlasmaBlade n=43 breasts The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 breasts Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Postoperative Pain	4.47 units on a scale Standard Deviation 2.05	4.66 units on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Intraoperative

Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.

Outcome measures

Measure	PEAK PlasmaBlade n=43 breasts The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 breasts Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Estimated Blood Loss	56.59 mL Standard Deviation 48.44	64.27 mL Standard Deviation 34.23

SECONDARY outcome

Timeframe: Intraoperative

Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.

Outcome measures

Measure	PEAK PlasmaBlade n=43 breasts The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 breasts Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Operative Time	37.40 minutes Standard Deviation 15.52	41.55 minutes Standard Deviation 11.61

SECONDARY outcome

Timeframe: Intraoperative

Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.

Outcome measures

Measure	PEAK PlasmaBlade n=43 breasts The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 breasts Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Amount of Tissue Removed	685.92 g Standard Deviation 347.08	649.18 g Standard Deviation 322.07

SECONDARY outcome

Timeframe: Intraoperative

Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.

Amount of tissue (g) removed over time (min)

Outcome measures

Measure	PEAK PlasmaBlade n=43 breasts The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 breasts Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Dissection Performance	19.81 g/min Standard Deviation 10.65	15.99 g/min Standard Deviation 7.80

Adverse Events

PEAK PlasmaBlade

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	PEAK PlasmaBlade n=43 participants at risk The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 participants at risk Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Surgical and medical procedures Hematoma	2.3% 1/43 • Number of events 1	0.00% 0/43

Other adverse events

Measure	PEAK PlasmaBlade n=43 participants at risk The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Standard of Care (SOC) n=43 participants at risk Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Surgical and medical procedures Wound dehiscence	2.3% 1/43 • Number of events 1	0.00% 0/43
Surgical and medical procedures Hematoma	2.3% 1/43 • Number of events 1	2.3% 1/43 • Number of events 1
Surgical and medical procedures Seroma	2.3% 1/43 • Number of events 1	7.0% 3/43 • Number of events 3

Additional Information

Robert Swain, PhD

Medtronic Surgical Technologies

Phone: +1 (603) 294-5428

Email: robert.e.swain@medtronic.com

Results disclosure agreements

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

Restriction type: LTE60