Harmonic Scalpel Vs. 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:
- the time taken to complete the operation
- drainage volume in the days immediately following surgery,
- patient pain in the days immediately following surgery.
|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|
- Time for Operation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]Time to complete the breast reduction per breast.
- 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.
|Study Start Date:||March 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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
Electrocautery used to reduce breast on this side
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819260
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Carolyn L Kerrigan, MD||DHMC|
|Study Director:||Todd E Burdette, MD||DHMC|