Back to resultsHarmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
Primary Purpose
Hyperplasia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harmonic Scalpel
Electrocautery
Sponsored by
About this trial
This is an interventional treatment trial for Hyperplasia focused on measuring Mammaplasty, Electrocoagulation, Breast
Eligibility 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
Sites / Locations
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Harmonic Reduced Breast
Electrocautery Reduced Breast
Arm Description
harmonic scalpel used to reduce breast on that side
Electrocautery (current practice = control) used to reduce breast on that side
Outcomes
Primary Outcome Measures
Time for Operation
Time to complete the breast reduction per breast.
Secondary Outcome Measures
Volume of Drainage in Surgical Drains
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
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
A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.
Full Information
NCT ID
NCT00819260
First Posted
January 6, 2009
Last Updated
May 17, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Ethicon Endo-Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00819260
Brief Title
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
Official Title
A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Significant result achieved after enrollment of 31 of planned 50 subjects.
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Ethicon Endo-Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
the time taken to complete the operation
drainage volume in the days immediately following surgery,
patient pain in the days immediately following surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperplasia
Keywords
Mammaplasty, Electrocoagulation, Breast
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Harmonic Reduced Breast
Arm Type
Experimental
Arm Description
harmonic scalpel used to reduce breast on that side
Arm Title
Electrocautery Reduced Breast
Arm Type
Active Comparator
Arm Description
Electrocautery (current practice = control) used to reduce breast on that side
Intervention Type
Device
Intervention Name(s)
Harmonic Scalpel
Intervention Description
harmonic scalpel used to reduce breast on this side
Intervention Type
Device
Intervention Name(s)
Electrocautery
Intervention Description
Electrocautery used to reduce breast on this side
Primary Outcome Measure Information:
Title
Time for Operation
Description
Time to complete the breast reduction per breast.
Time Frame
day of surgery
Secondary Outcome Measure Information:
Title
Volume of Drainage in Surgical Drains
Description
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.
Time Frame
within one week of surgery
Title
Pain Level in Surgical Sites
Description
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.
Time Frame
first week after surgery
Title
Hematoma
Description
A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.
Time Frame
first day after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn L Kerrigan, MD
Organizational Affiliation
DHMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Todd E Burdette, MD
Organizational Affiliation
DHMC
Official's Role
Study Director
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
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