Trial Outcomes & Findings for Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery (NCT NCT00819260)

Results Overview

Time to complete the breast reduction per breast.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

day of surgery

Results posted on

2013-05-20

Participant Flow

Recruitment ran from January 2008 to January 2010. All patients were recruited in one surgical clinic at Dartmouth Hitchcock Medical Center.

Forty-three women were identified as potential study participants from May to December 2009. Three were excluded, because two were unable to consent and one was under 18 years old. Nine women declined to participate. Of the remaining 31 patients (72.1% of those identified), all completed the informed consent, the surgery, and the follow-up process.

Participant milestones

Participant milestones
Measure	All Participants All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=31 Participants Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	44 years FULL_RANGE 0 • n=99 Participants
Sex: Female, Male Female	31 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	31 participants n=99 Participants

PRIMARY outcome

Timeframe: day of surgery

Population: Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.

Time to complete the breast reduction per breast.

Outcome measures

Outcome measures
Measure	Harmonic Reduced Breast n=31 Participants harmonic scalpel used to reduce breast on that side	Electrocautery Reduced Breast n=31 Participants Electrocautery (current practice = control) used to reduce breast on that side
Time for Operation	32.9 minutes Standard Deviation 14.7	31 minutes Standard Deviation 8.1

SECONDARY outcome

Timeframe: within one week of surgery

Population: All participants in the study.

An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.

Outcome measures

Outcome measures
Measure	Harmonic Reduced Breast n=31 Participants harmonic scalpel used to reduce breast on that side	Electrocautery Reduced Breast n=31 Participants Electrocautery (current practice = control) used to reduce breast on that side
Volume of Drainage in Surgical Drains	2.1 mL/hour Standard Deviation 1.4	2.8 mL/hour Standard Deviation 1.3

SECONDARY outcome

Timeframe: first week after surgery

Population: all study participants

An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.

Outcome measures

Outcome measures
Measure	Harmonic Reduced Breast n=31 Participants harmonic scalpel used to reduce breast on that side	Electrocautery Reduced Breast n=31 Participants Electrocautery (current practice = control) used to reduce breast on that side
Pain Level in Surgical Sites	4 units on a scale Standard Deviation 3.2	4 units on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: first day after surgery

Population: entire study population

A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.

Outcome measures

Outcome measures
Measure	Harmonic Reduced Breast n=31 Participants harmonic scalpel used to reduce breast on that side	Electrocautery Reduced Breast n=31 Participants Electrocautery (current practice = control) used to reduce breast on that side
Hematoma	0 participants	0 participants

Adverse Events

Harmonic Reduced Breast

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Electrocautery Reduced Breast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Harmonic Reduced Breast n=31 participants at risk harmonic scalpel used to reduce breast on that side	Electrocautery Reduced Breast n=31 participants at risk Electrocautery (current practice = control) used to reduce breast on that side
Skin and subcutaneous tissue disorders Infected seroma	3.2% 1/31 • Number of events 1	0.00% 0/31

Other adverse events

Adverse event data not reported

Additional Information

Carolyn L. Kerrigan MD

Dartmouth-Hitchcock

Phone: 603-650-5148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place