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

Primary Purpose

Osteo Arthritis Shoulders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control
Air Barrier System
Sponsored by
Nimbic Systems, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteo Arthritis Shoulders focused on measuring Total shoulder replacement, operating room air, surgical site infection, airborne CFU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Candidate for total shoulder arthroplasty

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Control

    Air Barrier System

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    CFU counts
    Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
    Particle counts
    Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 13, 2018
    Last Updated
    December 19, 2018
    Sponsor
    Nimbic Systems, LLC
    Collaborators
    Texas Orthopedic Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03782675
    Brief Title
    Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
    Official Title
    Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nimbic Systems, LLC
    Collaborators
    Texas Orthopedic Hospital

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Shoulders
    Keywords
    Total shoulder replacement, operating room air, surgical site infection, airborne CFU

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm 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.
    Arm Title
    Air Barrier System
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Control
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Air Barrier System
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    CFU counts
    Description
    Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
    Time Frame
    Four months
    Title
    Particle counts
    Description
    Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
    Time Frame
    Four months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Candidate for total shoulder arthroplasty Exclusion Criteria: Prior history of infection Revision surgery Screens positive for MRSA
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gregory Stocks, MD
    Phone
    713-799-8600
    Email
    stocks@fondren.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Self
    Phone
    284-565-5715
    Email
    self@nimbicsystems.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory Stocks, MD
    Organizational Affiliation
    Texas Orthopedic Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19913327
    Citation
    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.
    Results Reference
    background

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

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