Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Air Barrier System; Other: Control

• Registration Number: NCT03473405
• Lead Sponsor: Nimbic Systems, LLC

Brief Summary

This 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 knee 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 at the surgery site during total knee arthroplasty surgery.

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13
• 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 knee 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
Air Barrier System	Air Barrier System	In the experimental (intervention) 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.
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 is turned on or not.

Primary Outcome Measures

Name	Time	Method
Compare the number of colony-forming units captured at incision sites	Four months	A length of tubing will be placed at the incision and will draw air onto agar plates that are changed every ten minutes in both the control and ABS arms.