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Device to Reduce Surgery Site Contamination

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ClinicalTrials.gov Identifier: NCT00972153
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : May 18, 2010
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC

Tracking Information
First Submitted Date  ICMJE September 2, 2009
First Posted Date  ICMJE September 4, 2009
Results First Submitted Date  ICMJE April 22, 2010
Results First Posted Date  ICMJE May 18, 2010
Last Update Posted Date March 16, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Surgery Site CFU Density [ Time Frame: Ten minute intervals throughout surgery ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Surgery Site CFU Density [ Time Frame: 1 week ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter [ Time Frame: Ten minute intervals throughout surgery ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Surgery site particulate density [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Device to Reduce Surgery Site Contamination
Official Title  ICMJE Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Surgery
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • No Intervention: No device used
  • Sham Comparator: Device attached, not activated
    Intervention: Device: Sham Air Barrier System device
  • Experimental: Device deployed and activated
    Intervention: Device: Air Barrier System Device
Publications * Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2009)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Candidate for primary total hip arthroplasty

Exclusion Criteria:

  • Prior history of infection
  • Revision arthroplasty
  • Screens positive for MRSA
  • Undergoing hemiarthroplasty or resurfacing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972153
Other Study ID Numbers  ICMJE ABS001-0912403
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nimbic Systems, LLC
Study Sponsor  ICMJE Nimbic Systems, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory Stocks, MD Fondren Orthopaedic Group
PRS Account Nimbic Systems, LLC
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP