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

Not Applicable

• Conditions: Osteo Arthritis Shoulders

• 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.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-19
• Last Update Submitted: 2018-12-19
• Study First Posted: 2018-12-20
• Last Update Posted: 2018-12-20
• Study Start: 2019-02
• Primary Completion: 2019-05
• Study Completion: 2019-07

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

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.