Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00819260
• Collaborator: Ethicon Endo-Surgery (Industry)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 11.1
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.

The three metrics are:

1. the time taken to complete the operation

2. drainage volume in the days immediately following surgery,

3. patient pain in the days immediately following surgery.

Condition or Disease	Intervention/Treatment	Phase
Hyperplasia	Device: Harmonic Scalpel; Device: Electrocautery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Harmonic Reduced Breast harmonic scalpel used to reduce breast on that side	Device: Harmonic Scalpel; harmonic scalpel used to reduce breast on this side
Active Comparator: Electrocautery Reduced Breast Electrocautery (current practice = control) used to reduce breast on that side	Device: Electrocautery; Electrocautery used to reduce breast on this side

Outcome Measures

Primary Outcome Measures

1. Time for Operation [day of surgery]

   Time to complete the breast reduction per breast.

Secondary Outcome Measures

1. Volume of Drainage in Surgical Drains [within one week of surgery]

   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.

2. Pain Level in Surgical Sites [first week after surgery]

   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.

3. Hematoma [first day after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.

Exclusion Criteria:

• under 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center
• Ethicon Endo-Surgery

Investigators

• Principal Investigator: Carolyn L Kerrigan, MD, DHMC
• Study Director: Todd E Burdette, MD, DHMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00819260
• Other Study ID Numbers: 1182DF9
• First Posted: Jan 8, 2009
• Last Update Posted: May 20, 2013
• Last Verified: May 1, 2013

• Keywords provided by Dartmouth-Hitchcock Medical Center: Mammaplasty; Electrocoagulation; Breast
• Additional relevant MeSH terms: Hyperplasia

Study Results

Participant Flow

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

Arm/Group Title	All Participants
Arm/Group Description	All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
Period Title: Overall Study
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
Overall Participants	31
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 100%
>=65 years	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	44 (0)
Sex: Female, Male (Count of Participants)
Female	31 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	31 100%

Outcome Measures

1. Primary Outcome

Title	Time for Operation
Description	Time to complete the breast reduction per breast.
Time Frame	day of surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Harmonic Reduced Breast	Electrocautery Reduced Breast
Arm/Group Description	harmonic scalpel used to reduce breast on that side	Electrocautery (current practice = control) used to reduce breast on that side
Measure Participants	31	31
Median (Standard Deviation) [minutes]	32.9 (14.7)	31 (8.1)

2. Secondary Outcome

Title	Volume of Drainage in Surgical Drains
Description	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.
Time Frame	within one week of surgery

Outcome Measure Data

Analysis Population Description

All participants in the study.

Arm/Group Title	Harmonic Reduced Breast	Electrocautery Reduced Breast
Arm/Group Description	harmonic scalpel used to reduce breast on that side	Electrocautery (current practice = control) used to reduce breast on that side
Measure Participants	31	31
Median (Standard Deviation) [mL/hour]	2.1 (1.4)	2.8 (1.3)

3. Secondary Outcome

Title	Pain Level in Surgical Sites
Description	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.
Time Frame	first week after surgery

Outcome Measure Data

Analysis Population Description

all study participants

Arm/Group Title	Harmonic Reduced Breast	Electrocautery Reduced Breast
Arm/Group Description	harmonic scalpel used to reduce breast on that side	Electrocautery (current practice = control) used to reduce breast on that side
Measure Participants	31	31
Median (Standard Deviation) [units on a scale]	4 (3.2)	4 (3)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

entire study population

Arm/Group Title	Harmonic Reduced Breast	Electrocautery Reduced Breast
Arm/Group Description	harmonic scalpel used to reduce breast on that side	Electrocautery (current practice = control) used to reduce breast on that side
Measure Participants	31	31
Number [participants]	0 0%	0 NaN

Adverse Events

Arm/Group Title	Harmonic Reduced Breast		Electrocautery Reduced Breast
Arm/Group Description	harmonic scalpel used to reduce breast on that side		Electrocautery (current practice = control) used to reduce breast on that side
All Cause Mortality
	Harmonic Reduced Breast		Electrocautery Reduced Breast
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Harmonic Reduced Breast		Electrocautery Reduced Breast
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/31 (3.2%)		0/31 (0%)
Skin and subcutaneous tissue disorders
Infected seroma	1/31 (3.2%)	1	0/31 (0%)	0
Other (Not Including Serious) Adverse Events
	Harmonic Reduced Breast		Electrocautery Reduced Breast
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)

Limitations/Caveats

We made a first analysis after 26 (intended enrollment 50) patients were enrolled and a result was strongly suggested. While the analysis was refined, 5 more patients enrolled. The study was then stopped after 31 patients enrolled.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.