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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2009

Last Updated Date

May 17, 2013

Start Date ^ICMJE

March 2009

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time for Operation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

Time to complete the breast reduction per breast.

Original Primary Outcome Measures ^ICMJE

Time for operation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00819260 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Official Title ^ICMJE

A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Hyperplasia

Intervention ^ICMJE

Device: Harmonic Scalpel
harmonic scalpel used to reduce breast on this side
Device: Electrocautery
Electrocautery used to reduce breast on this side

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00819260

Other Study ID Numbers ^ICMJE

1182DF9

Has Data Monitoring Committee

Responsible Party

Dartmouth-Hitchcock Medical Center

Study Sponsor ^ICMJE

Dartmouth-Hitchcock Medical Center

Collaborators ^ICMJE

Ethicon Endo-Surgery

Investigators ^ICMJE

Principal Investigator:	Carolyn L Kerrigan, MD	DHMC
Study Director:	Todd E Burdette, MD	DHMC

Information Provided By

Dartmouth-Hitchcock Medical Center

Verification Date

May 2013

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

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