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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
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Surgery Device: Air Barrier System Device

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow
Study Start Date : November 2009
Primary Completion Date : October 2010
Study Completion Date : December 2010

Arm Intervention/treatment
No Intervention: No device
Experimental: Device deployed Device: Air Barrier System Device
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.



Primary Outcome Measures :
  1. Surgery Site CFU Density [ Time Frame: Ten-minute intervals throughout procedure ]
    CFU culture counts for samples taken in surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria:

  • Prior history of infection
  • Revision surgery
  • Screens positive for MRSA

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): NCT01262105


Locations
United States, Texas
Texas Orthopedic Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nimbic Systems, LLC
Investigators
Principal Investigator: David Wimberley, MD Fondren Orthopaedic Group

Publications:
Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01262105     History of Changes
Other Study ID Numbers: ABS-002
First Posted: December 17, 2010    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Nimbic Systems, LLC:
CFU
surgery site