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

Nimbic Systems

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Other: Control; Device: Air Barrier System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03473405

ABS-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for total knee arthroplasty

Exclusion criteria

• Prior history of infection
• Revision surgery
• Screens positive for MRSA

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Control

Sham Comparator group

Description:

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.

Treatment:

Other: Control

Air Barrier System

Experimental group

Description:

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.

Treatment:

Device: Air Barrier System