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

January 6, 2009
May 17, 2013
March 2009
January 2010   (final data collection date for primary outcome measure)
Time for Operation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
Time to complete the breast reduction per breast.
Time for operation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00819260 on ClinicalTrials.gov Archive Site
  • 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.
  • Volume of drainage in surgical drains [ Time Frame: within one week of surgery ] [ Designated as safety issue: No ]
  • Pain level in surgical sites [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
  • Hematoma [ Time Frame: first day after surgery ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hyperplasia
  • Device: Harmonic Scalpel
    harmonic scalpel used to reduce breast on this side
  • Device: Electrocautery
    Electrocautery used to reduce breast on this side
  • Experimental: Harmonic Reduced Breast
    harmonic scalpel used to reduce breast on that side
    Intervention: Device: Harmonic Scalpel
  • Active Comparator: Electrocautery Reduced Breast
    Electrocautery (current practice = control) used to reduce breast on that side
    Intervention: Device: Electrocautery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00819260
1182DF9
No
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Ethicon Endo-Surgery
Principal Investigator: Carolyn L Kerrigan, MD DHMC
Study Director: Todd E Burdette, MD DHMC
Dartmouth-Hitchcock Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP