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Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

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: NCT01559506
Recruitment Status : Completed
First Posted : March 21, 2012
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC

Study Description
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Brief Summary:
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures

Condition or disease Intervention/treatment Phase
Surgery Device: Air Barrier System device Not Applicable

Detailed Description:
The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: ABS to Reduce Contamination in Spine Surgery
Study Start Date : November 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Arms and Interventions
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Arm Intervention/treatment
No Intervention: No device
Subject does not receive ABS system
Experimental: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.
 Device: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.


Outcome Measures
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Primary Outcome Measures :
  1. CFU Density [ Time Frame: Surgical case CFU density will be determined at up to 1 month from completion of surgical cases ]
    Colony-forming unit density at incision site (CFU/m3)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria:

  • Active infection
  • Prior prosthesis infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559506


Locations
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United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nimbic Systems, LLC
Investigators
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Principal Investigator: Rabih O Darouiche, MD Baylor College of Medicine
Principal Investigator: Sean Self Nimbic Systems
More Information
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Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01559506    
Other Study ID Numbers: ABS-003
First Posted: March 21, 2012    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Nimbic Systems, LLC:
CFU
surgery site