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Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

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ClinicalTrials.gov Identifier: NCT00819260
Recruitment Status : Terminated (Significant result achieved after enrollment of 31 of planned 50 subjects.)
First Posted : January 8, 2009
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hyperplasia
Interventions Device: Harmonic Scalpel
Device: Electrocautery
Enrollment 31
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 Details 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
Hide 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
Arm/Group Title All Participants
Hide Arm/Group Description Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
44
(20 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Time for Operation
Hide Description Time to complete the breast reduction per breast.
Time Frame day of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
harmonic scalpel used to reduce breast on that side
Electrocautery (current practice = control) used to reduce breast on that side
Overall Number of Participants Analyzed 31 31
Median (Standard Deviation)
Unit of Measure: minutes
32.9  (14.7) 31  (8.1)
2.Secondary Outcome
Title Volume of Drainage in Surgical Drains
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the study.
Arm/Group Title Harmonic Reduced Breast Electrocautery Reduced Breast
Hide Arm/Group Description:
harmonic scalpel used to reduce breast on that side
Electrocautery (current practice = control) used to reduce breast on that side
Overall Number of Participants Analyzed 31 31
Median (Standard Deviation)
Unit of Measure: mL/hour
2.1  (1.4) 2.8  (1.3)
3.Secondary Outcome
Title Pain Level in Surgical Sites
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all study participants
Arm/Group Title Harmonic Reduced Breast Electrocautery Reduced Breast
Hide Arm/Group Description:
harmonic scalpel used to reduce breast on that side
Electrocautery (current practice = control) used to reduce breast on that side
Overall Number of Participants Analyzed 31 31
Median (Standard Deviation)
Unit of Measure: units on a scale
4  (3.2) 4  (3)
4.Secondary Outcome
Title Hematoma
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
entire study population
Arm/Group Title Harmonic Reduced Breast Electrocautery Reduced Breast
Hide Arm/Group Description:
harmonic scalpel used to reduce breast on that side
Electrocautery (current practice = control) used to reduce breast on that side
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Harmonic Reduced Breast Electrocautery Reduced Breast
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Harmonic Reduced Breast Electrocautery Reduced Breast
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/31 (3.23%)      0/31 (0.00%)    
Skin and subcutaneous tissue disorders     
Infected seroma [1]  1/31 (3.23%)  1 0/31 (0.00%)  0
[1]
Required operative evacuation, antibiotics and prolonged wound care.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Harmonic Reduced Breast Electrocautery Reduced Breast
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/31 (0.00%)    
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.
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.
Results Point of Contact
Name/Title: Carolyn L. Kerrigan MD
Organization: Dartmouth-Hitchcock
Phone: 603-650-5148
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00819260     History of Changes
Other Study ID Numbers: 1182DF9
First Submitted: January 6, 2009
First Posted: January 8, 2009
Results First Submitted: November 29, 2011
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013