Device to Reduce Surgery Site Contamination - Spine
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.
|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|
- Surgery Site CFU Density [ Time Frame: Ten-minute intervals throughout procedure ] [ Designated as safety issue: No ]CFU culture counts for samples taken in surgery.
|Study Start Date:||November 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262105
|United States, Texas|
|Texas Orthopedic Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David Wimberley, MD||Fondren Orthopaedic Group|