Osteo Arthritis Shoulders
Conditions
Keywords
Total shoulder replacement, operating room air, surgical site infection, airborne CFU
Brief summary
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
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.
Interventions
DEVICEControl
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.
DEVICEAir 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.
Sponsors
Texas Orthopedic Hospital
Nimbic Systems, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for total shoulder arthroplasty
Exclusion criteria
* Prior history of infection * Revision surgery * Screens positive for MRSA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CFU counts | Four months | Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm |
| Particle counts | Four months | Inter-arm comparison of particle counts taken during both the Control arm and ABS arm. |
Contacts
Primary ContactGregory Stocks, MD
Backup ContactSean Self
Outcome results
None listed