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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782675
Recruitment Status : Unknown
Verified December 2018 by Nimbic Systems, LLC.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
Texas Orthopedic Hospital
Information provided by (Responsible Party):
Nimbic Systems, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Shoulders Device: Control Device: Air Barrier System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: 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 the device is turned on or not.
 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.
Experimental: Air Barrier System
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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. CFU counts [ Time Frame: Four months ]
    Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm

  2. Particle counts [ Time Frame: Four months ]
    Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for total shoulder arthroplasty

Exclusion Criteria:

  • Prior history of infection
  • Revision surgery
  • Screens positive for MRSA
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782675


Contacts
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Contact: Gregory Stocks, MD 713-799-8600 stocks@fondren.com
Contact: Sean Self 284-565-5715 self@nimbicsystems.com

Sponsors and Collaborators
Nimbic Systems, LLC
Texas Orthopedic Hospital
Investigators
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Principal Investigator: Gregory Stocks, MD Texas Orthopedic Hospital
More Information
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Publications:

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Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT03782675    
Other Study ID Numbers: ABS-104
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nimbic Systems, LLC:
Total shoulder replacement
operating room air
surgical site infection
airborne CFU
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases