NCT03782675

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nimbic Systems, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteo Arthritis Shoulders

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-05-01
• Completion: 2019-07-01
• First posted: 2018-12-20
• Last updated: 2018-12-20

Regulatory

• FDA-regulated device study