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Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

NCT00819260 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-05-20

Study results available
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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:

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.

Conditions

  • Hyperplasia

Interventions

DEVICE

Harmonic Scalpel

harmonic scalpel used to reduce breast on this side

DEVICE

Electrocautery

Electrocautery used to reduce breast on this side

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Carolyn L Kerrigan, MD · DHMC

  • Todd E Burdette, MD · DHMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-01-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819260 on ClinicalTrials.gov