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

Nimbic Systems

Status: Unknown

Conditions: Osteo Arthritis Shoulders

Treatments: Device: Control; Device: Air Barrier System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03782675

ABS-104

Details and patient eligibility

About

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.

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 and particles at the surgery site during total arthroplasty surgery.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for total shoulder 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 the device is turned on or not.

Treatment:

Device: Control

Air Barrier System

Experimental group

Description:

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.

Treatment:

Device: Air Barrier System