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PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty (PRECISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT00943150
First received: July 20, 2009
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Elastosis
Interventions: Device: PEAK PlasmaBlade
Procedure: Standard of Care (SOC)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PEAK PlasmaBlade The PEAK PlasmaBlade for the abdominoplasty procedure.
Standard of Care (SOC) The scalpel and electrocautery will be used for the abdominoplasty procedure.

Participant Flow:   Overall Study
    PEAK PlasmaBlade     Standard of Care (SOC)  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
PEAK PlasmaBlade The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
Standard of Care (SOC) The scalpel and electrocautery will be used for the abdominoplasty procedure.
Total Total of all reporting groups

Baseline Measures
    PEAK PlasmaBlade     Standard of Care (SOC)     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: years]
Mean ( Full Range ) 		  42.11  
  ( 28 to 56 )   		  44.40  
  ( 28 to 58 )   		  43.26  
  ( 28 to 58 )  
Gender  
[units: participants]
 		     
Female     10     10     20  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   Acute Thermal Injury Depth   [ Time Frame: Immediately postoperative ]
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2.  Primary:   Inflammatory Cell Count   [ Time Frame: 0, 3, and 6 weeks ]
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3.  Secondary:   Total Drainage Output   [ Time Frame: 0 to 10 days postoperatively ]
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4.  Secondary:   Change in Hemoglobin   [ Time Frame: Intraoperative ]
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5.  Secondary:   Narcotic Consumption   [ Time Frame: Intraoperative and postoperative (0 to 10 days) ]
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6.  Secondary:   Postoperative Pain Levels   [ Time Frame: Postoperative (0 to 10 days) ]
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7.  Secondary:   Activity Level   [ Time Frame: Postoperative (0 to 10 days) ]
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8.  Secondary:   Diet Volume   [ Time Frame: Postoperative (0 to 10 days) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Robert Swain, PhD
Organization: Medtronic Surgical Technologies
phone: (+1-603) 294-5428
e-mail: robert.e.swain@medtronic.com


No publications provided by Medtronic Surgical Technologies

Publications automatically indexed to this study:


Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT00943150     History of Changes
Other Study ID Numbers: PEAK VP-00055
Study First Received: July 20, 2009
Results First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board