Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty

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 colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.

Detailed Description
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The Air Barrier System (ABS) 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 ABS can reduce the presence of airborne CFU and particles at the surgery site during total arthroplasty surgery.

Official Title
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Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.

Conditions
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Osteo Arthritis Shoulders

Intervention / Treatment
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* Device: Control
* Device: Air Barrier System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for total shoulder arthroplasty Exclusion Criteria: Prior history of infection Revision surgery Screens positive for MRSA

Ages Eligible for Study
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Minimum Age: 18 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device the device is turned on or not. | Device: Control<br>* The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.<br>|
| Experimental: Air Barrier System<br>In the experimental (interventional) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not. | Device: Air Barrier System<br>* The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFU counts | Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm | Four months | 
| Particle counts | Inter-arm comparison of particle counts taken during both the Control arm and ABS arm. | Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total shoulder replacement, operating room air, surgical site infection, airborne CFU