Device to Reduce Surgery Site Contamination

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery

Intervention / Treatment
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* Device: Air Barrier System Device
* Device: Sham Air Barrier System device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for primary total hip arthroplasty Exclusion Criteria: Prior history of infection Revision arthroplasty Screens positive for MRSA Undergoing hemiarthroplasty or resurfacing
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No device used<br> | |
| Sham Comparator: Device attached, not activated<br> | Device: Sham Air Barrier System device<br>* 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.<br>|
| Experimental: Device deployed and activated<br> | Device: Air Barrier System Device<br>* Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Site CFU Density | 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. | Ten minute intervals throughout surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 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. | Ten minute intervals throughout surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decrease in CFU density at surgery site, Decrease in airborne particulate at surgery site