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Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559506
First Posted: March 21, 2012
Last Update Posted: March 17, 2015
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.
Information provided by (Responsible Party):
Nimbic Systems, LLC
  Purpose
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

Condition Intervention
Surgery Device: Air Barrier System device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: ABS to Reduce Contamination in Spine Surgery

Further study details as provided by Nimbic Systems, LLC:

Primary Outcome Measures:
  • CFU Density [ Time Frame: Surgical case CFU density will be determined at up to 1 month from completion of surgical cases ]
    Colony-forming unit density at incision site (CFU/m3)


Enrollment: 41
Study Start Date: November 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No device
Subject does not receive ABS system
Experimental: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.
Device: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria:

  • Active infection
  • Prior prosthesis infection
  Contacts and Locations
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): NCT01559506


Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nimbic Systems, LLC
Investigators
Principal Investigator: Rabih O Darouiche, MD Baylor College of Medicine
Principal Investigator: Sean Self Nimbic Systems
  More Information

Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01559506     History of Changes
Other Study ID Numbers: ABS-003
First Submitted: March 14, 2012
First Posted: March 21, 2012
Results First Submitted: February 25, 2015
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Nimbic Systems, LLC:
CFU
surgery site