Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00819260
• Other study ID #: 1182DF9
• Status: Terminated
• Phase: N/A
• First received: January 6, 2009
• Last updated: May 17, 2013
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia

Intervention

Device:
• Harmonic Scalpel
harmonic scalpel used to reduce breast on this side
• Electrocautery
Electrocautery used to reduce breast on this side

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for Operation	Time to complete the breast reduction per breast.	day of surgery	No
Secondary	Volume of Drainage in Surgical Drains	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	No
Secondary	Pain Level in Surgical Sites	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	No
Secondary	Hematoma	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	Yes