Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

May 17, 2013 updated by: Dartmouth-Hitchcock Medical Center

A Randomized Clinical Trial Comparing the Harmonic Scalpel to 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:

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Electrocautery
Electrocautery used to reduce breast on this side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Operation
Time Frame: day of surgery
Time to complete the breast reduction per breast.
day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within one week of surgery
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.
first week after surgery
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.
first day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Ethicon Endo-Surgery

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182DF9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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