Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC
ClinicalTrials.gov Identifier:
NCT01559506
First received: March 14, 2012
Last updated: March 16, 2015
Last verified: March 2015
  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
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 ] [ Designated as safety issue: No ]
    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

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
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: 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

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
Results First Received: February 25, 2015
Last Updated: March 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Nimbic Systems, LLC:
CFU
surgery site

ClinicalTrials.gov processed this record on August 02, 2015