Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
NCT ID: NCT03782675
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-02-28
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Control
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.
Control
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.
Air Barrier System
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.
Air Barrier System
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.
Interventions
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Control
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.
Air Barrier System
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Revision surgery
* Screens positive for MRSA
18 Years
ALL
No
Sponsors
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Texas Orthopedic Hospital
UNKNOWN
Nimbic Systems, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Stocks, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Orthopedic Hospital
Central Contacts
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References
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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.
Other Identifiers
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ABS-104
Identifier Type: -
Identifier Source: org_study_id