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Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

This study has been terminated.
(Significant result achieved after enrollment of 31 of planned 50 subjects.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00819260
First Posted: January 8, 2009
Last Update Posted: May 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
Results First Submitted: November 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Hyperplasia
Interventions: Device: Harmonic Scalpel
Device: Electrocautery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment ran from January 2008 to January 2010. All patients were recruited in one surgical clinic at Dartmouth Hitchcock Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-three women were identified as potential study participants from May to December 2009. Three were excluded, because two were unable to consent and one was under 18 years old. Nine women declined to participate. Of the remaining 31 patients (72.1% of those identified), all completed the informed consent, the surgery, and the follow-up process.

Reporting Groups
  Description
All Participants All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.

Participant Flow:   Overall Study
    All Participants
STARTED   31 
COMPLETED   31 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   31 
>=65 years   0 
Age 
[Units: Years]
Median (Full Range)
 44 
 (20 to 62) 
Gender 
[Units: Participants]
 
Female   31 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time for Operation   [ Time Frame: day of surgery ]

2.  Secondary:   Volume of Drainage in Surgical Drains   [ Time Frame: within one week of surgery ]

3.  Secondary:   Pain Level in Surgical Sites   [ Time Frame: first week after surgery ]

4.  Secondary:   Hematoma   [ Time Frame: first day after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We made a first analysis after 26 (intended enrollment 50) patients were enrolled and a result was strongly suggested. While the analysis was refined, 5 more patients enrolled. The study was then stopped after 31 patients enrolled.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carolyn L. Kerrigan MD
Organization: Dartmouth-Hitchcock
phone: 603-650-5148
e-mail: carolyn.kerrigan@hitchcock.org



Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00819260     History of Changes
Other Study ID Numbers: 1182DF9
First Submitted: January 6, 2009
First Posted: January 8, 2009
Results First Submitted: November 29, 2011
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013



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