Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
This study is currently recruiting participants.
Verified March 2012 by Nimbic Systems, LLC
Sponsor:
Nimbic Systems, LLC
Information provided by (Responsible Party):
Nimbic Systems, LLC
ClinicalTrials.gov Identifier:
NCT01559506
First received: March 14, 2012
Last updated: March 19, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 14, 2012 | ||||||||
| Last Updated Date | March 19, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
CFU density [ Time Frame: Surgical case CFU density will be determined at up to 1 month from completion of surgical cases ] [ Designated as safety issue: No ] Colony-forming unit density at incision site (CFU/m3) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01559506 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Surgery | ||||||||
| Intervention ICMJE | Device: Air Barrier System device
Device is deployed adjacent to the surgery site and activated. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | January 2015 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01559506 | ||||||||
| Other Study ID Numbers ICMJE | ABS-003 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Nimbic Systems, LLC | ||||||||
| Study Sponsor ICMJE | Nimbic Systems, LLC | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Nimbic Systems, LLC | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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