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

Osteo Arthritis Shoulders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03782675
• Other study ID #: ABS-104
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: July 2019

Study information

• Verified date: December 2018
• Source: Nimbic Systems, LLC
• Contact: Gregory Stocks, MD
• Phone: 713-799-8600
• Email: stocks[@]fondren.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate for total shoulder arthroplasty

Exclusion Criteria:

• Prior history of infection

• Revision surgery

• Screens positive for MRSA

Related Conditions & MeSH terms

• Osteo Arthritis Shoulders
• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nimbic Systems, LLC	Texas Orthopedic Hospital

References & Publications (1)

Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CFU counts	Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm	Four months
Primary	Particle counts	Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.	Four months