Device to Reduce Surgery Site Contamination - Spine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC
ClinicalTrials.gov Identifier:
NCT01262105
First received: December 15, 2010
Last updated: April 9, 2012
Last verified: April 2012
Results First Received: March 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Surgery
Intervention: Device: Air Barrier System Device

  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
No Device No text entered.
Device Deployed No text entered.

Participant Flow:   Overall Study
    No Device     Device Deployed  
STARTED     13     10  
COMPLETED     13     10  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
No Device No text entered.
Device Deployed No text entered.
Total Total of all reporting groups

Baseline Measures
    No Device     Device Deployed     Total  
Number of Participants  
[units: participants]
  13     10     23  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     7     15  
>=65 years     5     3     8  
Gender  
[units: Participants]
     
Female     7     5     12  
Male     6     5     11  
Region of Enrollment  
[units: participants]
     
United States     13     10     23  



  Outcome Measures

1.  Primary:   Surgery Site CFU Density   [ Time Frame: Ten-minute intervals throughout procedure ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sean Self
Organization: Nimbic Systems
phone: 281-565-5700
e-mail: self@nimbicsystems.com


Publications:

Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01262105     History of Changes
Other Study ID Numbers: ABS-002
Study First Received: December 15, 2010
Results First Received: March 14, 2012
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board