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Clinical Trials/NCT00819260
NCT00819260
Terminated
N/A

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

Dartmouth-Hitchcock Medical Center1 site in 1 country31 target enrollmentMarch 2009
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ConditionsHyperplasia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hyperplasia
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
31
Locations
1
Primary Endpoint
Time for Operation
Status
Terminated
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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:

  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.
Registry
clinicaltrials.gov
Start Date
March 2009
End Date
February 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Time for Operation

Time Frame: day of surgery

Time to complete the breast reduction per breast.

Secondary Outcomes

  • Hematoma(first day after surgery)
  • Volume of Drainage in Surgical Drains(within one week of surgery)
  • Pain Level in Surgical Sites(first week after surgery)

Study Sites (1)

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