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Device to Reduce Surgery Site Contamination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC
ClinicalTrials.gov Identifier:
NCT00972153
First received: September 2, 2009
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.


Condition Intervention
Surgery
Device: Air Barrier System Device
Device: Sham Air Barrier System device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Reduction of Airborne Particulate in the Surgical Field 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 surgery ] [ Designated as safety issue: No ]
    Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol "slit" sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter.


Secondary Outcome Measures:
  • Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter [ Time Frame: Ten minute intervals throughout surgery ] [ Designated as safety issue: No ]
    Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.


Enrollment: 29
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No device used
Sham Comparator: Device attached, not activated Device: Sham Air Barrier System device
Device is deployed to the surgery site, but the airflow is not activated. This intervention is used to determine any effects that the presence of the device alone may have.
Experimental: Device deployed and activated Device: Air Barrier System Device
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery 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 (e.g. bacteria colonies) and particulate at the surgery site.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for primary total hip arthroplasty

Exclusion Criteria:

  • Prior history of infection
  • Revision arthroplasty
  • Screens positive for MRSA
  • Undergoing hemiarthroplasty or resurfacing
  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: NCT00972153

Locations
United States, Texas
Texas Orthopedic Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nimbic Systems, LLC
Investigators
Principal Investigator: Gregory Stocks, MD Fondren Orthopaedic Group
  More Information

Publications:
Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT00972153     History of Changes
Other Study ID Numbers: ABS001-0912403
Study First Received: September 2, 2009
Results First Received: April 22, 2010
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nimbic Systems, LLC:
Decrease in CFU density at surgery site
Decrease in airborne particulate at surgery site

ClinicalTrials.gov processed this record on November 27, 2014