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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014