Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperplasia||Device: Harmonic Scalpel Device: Electrocautery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Time for Operation [ Time Frame: day of surgery ]Time to complete the breast reduction per breast.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|