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Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

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

Primary Outcome Measures :
  1. Time for Operation [ Time Frame: day of surgery ]
    Time to complete the breast reduction per breast.

Secondary Outcome Measures :
  1. Volume of Drainage in Surgical Drains [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819260

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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Ethicon Endo-Surgery
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Principal Investigator: Carolyn L Kerrigan, MD DHMC
Study Director: Todd E Burdette, MD DHMC

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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00819260     History of Changes
Other Study ID Numbers: 1182DF9
First Posted: January 8, 2009    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013
Last Verified: May 2013

Keywords provided by Dartmouth-Hitchcock Medical Center:

Additional relevant MeSH terms:
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Pathologic Processes