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Device to Reduce Surgery Site Contamination - Spine

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.
ClinicalTrials.gov Identifier: NCT01262105
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : April 9, 2012
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):
Nimbic Systems, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Surgery
Intervention: Device: Air Barrier System Device

  Participant Flow

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

Participant Flow:   Overall Study
    No Device   Device Deployed
STARTED   13   10 
COMPLETED   13   10 

  Baseline Characteristics

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
No Device No text entered.
Device Deployed No text entered.
Total Total of all reporting groups

Baseline Measures
   No Device   Device Deployed   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   10   23 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   8   7   15 
>=65 years   5   3   8 
[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

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

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


Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01262105     History of Changes
Other Study ID Numbers: ABS-002
First Submitted: December 15, 2010
First Posted: December 17, 2010
Results First Submitted: March 14, 2012
Results First Posted: April 9, 2012
Last Update Posted: April 11, 2012