Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
Not Applicable
- Conditions
- Osteo Arthritis Shoulders
- Interventions
- Device: ControlDevice: Air Barrier System
- Registration Number
- NCT03782675
- Lead Sponsor
- Nimbic Systems, LLC
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Candidate for total shoulder arthroplasty
Exclusion Criteria
- Prior history of infection
- Revision surgery
- Screens positive for MRSA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control 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. Air Barrier System 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method