Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Not Applicable

Terminated

• Conditions: Hyperplasia
• Interventions: Device: Harmonic Scalpel; Device: Electrocautery

• Registration Number: NCT00819260
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Study Start: 2009-03
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Results First Submitted: 2011-11-29
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Results First Posted: 2013-05-20
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Harmonic Reduced Breast	Harmonic Scalpel	harmonic scalpel used to reduce breast on that side
Electrocautery Reduced Breast	Electrocautery	Electrocautery (current practice = control) used to reduce breast on that side

Primary Outcome Measures

Name	Time	Method
Time for Operation	day of surgery	Time to complete the breast reduction per breast.

Secondary Outcome Measures

Name	Time	Method
Volume of Drainage in Surgical Drains	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.
Pain Level in Surgical Sites	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.
Hematoma	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.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States