<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/NCT04443803</url>
  </required_header>
  <id_info>
    <org_study_id>202005391</org_study_id>
    <nct_id>NCT04443803</nct_id>
  </id_info>
  <brief_title>Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement of Perioperative Infection Control Program</brief_title>
  <official_title>Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement of Perioperative Infection Control Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Randy Loftus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery&#xD;
      that are COVID-19 positive will be approached for patient consent.&#xD;
&#xD;
      OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for&#xD;
      sampling of 48 sampled time/locations per patient. Patient sampling locations will include&#xD;
      the nasopharynx and oropharynx. Operating room environmental locations will include areas in&#xD;
      the patient care arena such as the anesthesia machine. Samples of each location will be&#xD;
      obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet&#xD;
      light and other infection control practices that are currently in place, such as utilization&#xD;
      of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved&#xD;
      vascular care.&#xD;
&#xD;
      UV-C light for environmental cleaning is not regulated by the FDA.&#xD;
&#xD;
      Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples&#xD;
      will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed&#xD;
      for S. aureus as a process control. We will characterize the epidemiology of perioperative&#xD;
      SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative&#xD;
      infection control bundle and to serve as the platform for national dissemination of a&#xD;
      perioperative COVID-19 defense strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The operating room schedule will be reviewed each day by a research assistant for COVID-19&#xD;
      positive patients. Additionally, the research assistant will receive a page for every&#xD;
      emergency surgery that takes place in the OR.&#xD;
&#xD;
      OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times&#xD;
      throughout each case. These samples include:&#xD;
&#xD;
        -  11 samples that have been routinely used for S. aureus including nasopharyngeal.&#xD;
           Normally there are 13, but 2 samples are included in the subsequent environmental&#xD;
           locations: the adjustable pressure-limiting valve and agent dial at baseline and case&#xD;
           end.&#xD;
&#xD;
        -  1 sample from the endotracheal tube tip at case end, as positive control.&#xD;
&#xD;
        -  12 environmental locations at case end including anesthesia machine and each of the air&#xD;
           vents,&#xD;
&#xD;
        -  12 environmental locations matched after environmental cleaning, and&#xD;
&#xD;
        -  12 environmental locations matched after Surfacide Helios UV-C cleaning. The Surfacide&#xD;
           Helios UV-C cleaning robots will be used after all normal environmental cleaning of the&#xD;
           room has taken place.&#xD;
&#xD;
      A transmission event will be defined as 2 samples with detection of SARS-CoV-2 by RT-PCR,&#xD;
      with samples obtained from 2 distinct, epidemiologically-related reservoirs within a&#xD;
      surveillance unit. The OR PathTrac software platform will process transmission dynamics in&#xD;
      order to continually summarize the epidemiology of SARS-CoV transmission, with results&#xD;
      updated daily as case-pair data is continually entered into the program. This information&#xD;
      will be continually displayed to identify the most common reservoir of origin, the most&#xD;
      common transmission locations (vectors), and involvement of key portals of entry (stopcocks).&#xD;
      These will become improvement targets with feedback provided via automated failure mode&#xD;
      analysis reports. The research assistants will use the reports to continually optimize the&#xD;
      interventions during the observational period. The incidence and epidemiology of transmission&#xD;
      will be mapped before and after UV-C treatment and positive samples for SARS-CoV-2 examined&#xD;
      for viability by a UIHC laboratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perioperative transmission of SARS-CoV-2</measure>
    <time_frame>24 hours</time_frame>
    <description>Sars-CoV-2 transmission event</description>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>COVID-19</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times&#xD;
      throughout each case. These samples include:&#xD;
&#xD;
        -  11 samples that have been routinely used for S. aureus including nasopharyngeal.&#xD;
           Normally there are 13, but 2 samples are included in the subsequent environmental&#xD;
           locations: the adjustable pressure-limiting valve and agent dial at baseline and case&#xD;
           end.&#xD;
&#xD;
        -  1 sample from the endotracheal tube tip at case end, as positive control.&#xD;
&#xD;
        -  12 environmental locations at case end including anesthesia machine and each of the air&#xD;
           vents,&#xD;
&#xD;
        -  12 environmental locations matched after environmental cleaning, and&#xD;
&#xD;
        -  12 environmental locations matched after Surfacide Helios UV-C cleaning. The Surfacide&#xD;
           Helios UV-C cleaning robots will be used after all normal environmental cleaning of the&#xD;
           room has taken place.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery at the University of Iowa&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (at least 18 years old) COVID-19 positive patient undergoing surgery requiring&#xD;
             anesthesia and placement of a peripheral and/or central intravenous catheter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old, Shellfish, iodine, chlorhexidine allergies, COVID-19 negative status,&#xD;
             no anesthesia and/or placement of peripheral and/or central intravenous catheter&#xD;
             required&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.</citation>
    <PMID>32219407</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Randy Loftus</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04443803
org study id: 202005391
nct id: NCT04443803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery
      that are COVID-19 positive will be approached for patient consent.

      OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for
      sampling of 48 sampled time/locations per patient. Patient sampling locations will include
      the nasopharynx and oropharynx. Operating room environmental locations will include areas in
      the patient care arena such as the anesthesia machine. Samples of each location will be
      obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet
      light and other infection control practices that are currently in place, such as utilization
      of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved
      vascular care.

      UV-C light for environmental cleaning is not regulated by the FDA.

      Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples
      will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed
      for S. aureus as a process control. We will characterize the epidemiology of perioperative
      SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative
      infection control bundle and to serve as the platform for national dissemination of a
      perioperative COVID-19 defense strategy.
The operating room schedule will be reviewed each day by a research assistant for COVID-19
      positive patients. Additionally, the research assistant will receive a page for every
      emergency surgery that takes place in the OR.

      OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times
      throughout each case. These samples include:

        -  11 samples that have been routinely used for S. aureus including nasopharyngeal.
           Normally there are 13, but 2 samples are included in the subsequent environmental
           locations: the adjustable pressure-limiting valve and agent dial at baseline and case
           end.

        -  1 sample from the endotracheal tube tip at case end, as positive control.

        -  12 environmental locations at case end including anesthesia machine and each of the air
           vents,

        -  12 environmental locations matched after environmental cleaning, and

        -  12 environmental locations matched after Surfacide Helios UV-C cleaning. The Surfacide
           Helios UV-C cleaning robots will be used after all normal environmental cleaning of the
           room has taken place.

      A transmission event will be defined as 2 samples with detection of SARS-CoV-2 by RT-PCR,
      with samples obtained from 2 distinct, epidemiologically-related reservoirs within a
      surveillance unit. The OR PathTrac software platform will process transmission dynamics in
      order to continually summarize the epidemiology of SARS-CoV transmission, with results
      updated daily as case-pair data is continually entered into the program. This information
      will be continually displayed to identify the most common reservoir of origin, the most
      common transmission locations (vectors), and involvement of key portals of entry (stopcocks).
      These will become improvement targets with feedback provided via automated failure mode
      analysis reports. The research assistants will use the reports to continually optimize the
      interventions during the observational period. The incidence and epidemiology of transmission
      will be mapped before and after UV-C treatment and positive samples for SARS-CoV-2 examined
      for viability by a UIHC laboratory.
observational model: Case-Only
time perspective: Prospective
measure: Perioperative transmission of SARS-CoV-2
time frame: 24 hours
description: Sars-CoV-2 transmission event
OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times
      throughout each case. These samples include:

        -  11 samples that have been routinely used for S. aureus including nasopharyngeal.
           Normally there are 13, but 2 samples are included in the subsequent environmental
           locations: the adjustable pressure-limiting valve and agent dial at baseline and case
           end.

        -  1 sample from the endotracheal tube tip at case end, as positive control.

        -  12 environmental locations at case end including anesthesia machine and each of the air
           vents,

        -  12 environmental locations matched after environmental cleaning, and

        -  12 environmental locations matched after Surfacide Helios UV-C cleaning. The Surfacide
           Helios UV-C cleaning robots will be used after all normal environmental cleaning of the
           room has taken place.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
facility: 
country: United States
citation: Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.
PMID: 32219407
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Randy Loftus
investigator title: MD
mesh term: COVID-19