<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03782675</url>
  </required_header>
  <id_info>
    <org_study_id>ABS-104</org_study_id>
    <nct_id>NCT03782675</nct_id>
  </id_info>
  <brief_title>Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty</brief_title>
  <official_title>Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nimbic Systems, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas Orthopedic Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nimbic Systems, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine whether the Air Barrier System device reduces&#xD;
      airborne colony-forming units (e.g., bacteria) present at a surgery site during total&#xD;
      shoulder arthroplasty surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a&#xD;
      surgery site from ambient airborne contamination. This study examines the hypothesis that the&#xD;
      ABS can reduce the presence of airborne CFU and particles at the surgery site during total&#xD;
      arthroplasty surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CFU counts</measure>
    <time_frame>Four months</time_frame>
    <description>Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Particle counts</measure>
    <time_frame>Four months</time_frame>
    <description>Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Osteo Arthritis Shoulders</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air Barrier System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control</intervention_name>
    <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.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air Barrier System</intervention_name>
    <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.</description>
    <arm_group_label>Air Barrier System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate for total shoulder arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of infection&#xD;
&#xD;
          -  Revision surgery&#xD;
&#xD;
          -  Screens positive for MRSA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory Stocks, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Orthopedic Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gregory Stocks, MD</last_name>
    <phone>713-799-8600</phone>
    <email>stocks@fondren.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sean Self</last_name>
    <phone>284-565-5715</phone>
    <email>self@nimbicsystems.com</email>
  </overall_contact_backup>
  <reference>
    <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.</citation>
    <PMID>19913327</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total shoulder replacement</keyword>
  <keyword>operating room air</keyword>
  <keyword>surgical site infection</keyword>
  <keyword>airborne CFU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03782675
org study id: ABS-104
nct id: NCT03782675
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: CFU counts
time frame: Four months
description: Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
measure: Particle counts
time frame: Four months
description: Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
arm group label: Control
arm group type: Sham Comparator
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 group label: Air Barrier System
arm group type: Experimental
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: Control
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.
arm group label: Control
intervention type: Device
intervention name: Air Barrier System
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.
arm group label: Air Barrier System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory Stocks, MD
role: Principal Investigator
affiliation: Texas Orthopedic Hospital
last name: Gregory Stocks, MD
phone: 713-799-8600
email: stocks@fondren.com
last name: Sean Self
phone: 284-565-5715
email: self@nimbicsystems.com
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.
PMID: 19913327
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No