Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

This study is currently recruiting participants.
Verified March 2012 by Nimbic Systems, LLC
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC
ClinicalTrials.gov Identifier:
NCT01559506
First received: March 14, 2012
Last updated: March 19, 2012
Last verified: March 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science

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 ] [ Designated as safety issue: No ]
    Colony-forming unit density at incision site (CFU/m3)


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No device
Experimental: Device deployed
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559506

Locations
United States, Texas
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States
Contact: Rabih O Darouiche, MD       rabihd@bcm.edu   
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

No publications provided

Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT01559506     History of Changes
Other Study ID Numbers: ABS-003
Study First Received: March 14, 2012
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nimbic Systems, LLC:
CFU
surgery site

ClinicalTrials.gov processed this record on April 17, 2014