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Completed

NCT Number: NCT00972153

Device to Reduce Surgery Site Contamination

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.

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Key information

Conditions

Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Orthopedic Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidate for primary total hip arthroplasty

Exclusion criteria

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

Treatment and study plan

Air Barrier System Device

Device

Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.

Sham Air Barrier System device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nimbic Systems, LLC

Industry

Registry information

Official study title

Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2009
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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