Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

This study has been terminated.
(Significant result achieved after enrollment of 31 of planned 50 subjects.)
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00819260
First received: January 6, 2009
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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 Intervention
Hyperplasia
Device: Harmonic Scalpel
Device: Electrocautery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Time for Operation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    Time to complete the breast reduction per breast.


Secondary Outcome Measures:
  • Volume of Drainage in Surgical Drains [ Time Frame: within one week of surgery ] [ Designated as safety issue: No ]
    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.

  • Pain Level in Surgical Sites [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
    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.

  • Hematoma [ Time Frame: first day after surgery ] [ Designated as safety issue: Yes ]
    A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.


Enrollment: 31
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819260

Locations
United States, New Hampshire
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
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00819260     History of Changes
Other Study ID Numbers: 1182DF9
Study First Received: January 6, 2009
Results First Received: November 29, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Mammaplasty
Electrocoagulation
Breast

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014