Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Device to Reduce Surgery Site Contamination - Spine

This study has been completed.
Information provided by (Responsible Party):
Nimbic Systems, LLC Identifier:
First received: December 15, 2010
Last updated: April 9, 2012
Last verified: April 2012

December 15, 2010
April 9, 2012
November 2009
October 2010   (final data collection date for primary outcome measure)
Surgery Site CFU Density [ Time Frame: Ten-minute intervals throughout procedure ] [ Designated as safety issue: No ]
CFU culture counts for samples taken in surgery.
Same as current
Complete list of historical versions of study NCT01262105 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Device to Reduce Surgery Site Contamination - Spine
Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow

The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.

The Air Barrier System 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 Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.

Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Device: Air Barrier System Device
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.
  • No Intervention: No device
  • Experimental: Device deployed
    Intervention: Device: Air Barrier System Device
Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria:

  • Prior history of infection
  • Revision surgery
  • Screens positive for MRSA
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Nimbic Systems, LLC
Nimbic Systems, LLC
Not Provided
Principal Investigator: David Wimberley, MD Fondren Orthopaedic Group
Nimbic Systems, LLC
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP