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Device to Reduce Surgery Site Contamination - Spine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC
ClinicalTrials.gov Identifier:
NCT01262105
First received: December 15, 2010
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Surgery
 Device: Air Barrier System Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow

Further study details as provided by Nimbic Systems, LLC:

Primary Outcome Measures:
  • Surgery Site CFU Density [ Time Frame: Ten-minute intervals throughout procedure ] [ Designated as safety issue: No ]
    CFU culture counts for samples taken in surgery.


Enrollment: 23
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01262105     History of Changes
Other Study ID Numbers: ABS-002
Study First Received: December 15, 2010
Results First Received: March 14, 2012
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nimbic Systems, LLC:
CFU
surgery site

ClinicalTrials.gov processed this record on May 21, 2013