Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery - Full Text View

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center Ethicon Endo-Surgery
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00819260

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:

the time taken to complete the operation
drainage volume in the days immediately following surgery,
patient pain in the days immediately following surgery.

Condition	Intervention
Hyperplasia	Device: Harmonic Scalpel Device: Electrocautery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Harmonic Reduced Breast: Experimental harmonic scalpel used to reduce breast on that side	Device: Harmonic Scalpel harmonic scalpel used to reduce breast on this side
Electrocautery Reduced Breast: Active Comparator 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

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

Contacts

Contact: Todd E Burdette, MD	603 650 5148	burdette@hitchcock.org
Contact: Carolyn L Kerrigan, MD	603 650 5148	clk@hitchcock.org

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

Responsible Party:	DHMC ( Carolyn L. Kerrigan MD, principal investigator )
Study ID Numbers:	1182DF9
Study First Received:	January 6, 2009
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00819260
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

Mammaplasty
Electrocoagulation
Breast

Study placed in the following topic categories:

Hyperplasia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009