Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Dartmouth Health

Status: Terminated

Conditions: Hyperplasia

Treatments: Device: Electrocautery; Device: Harmonic Scalpel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00819260

1182DF9

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Harmonic Reduced Breast

Experimental group

Description:

harmonic scalpel used to reduce breast on that side

Treatment:

Device: Harmonic Scalpel

Electrocautery Reduced Breast

Active Comparator group

Description:

Electrocautery (current practice = control) used to reduce breast on that side

Treatment:

Device: Electrocautery