<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/NCT04449705</url>
  </required_header>
  <id_info>
    <org_study_id>202006248</org_study_id>
    <nct_id>NCT04449705</nct_id>
  </id_info>
  <brief_title>Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle</brief_title>
  <official_title>Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle</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>
      Surgical site infections increase patient morbidity and healthcare costs. The Centers for&#xD;
      Disease Control and Prevention emphasizes improved basic preventive measures to reduce&#xD;
      bacterial transmission and infections for patients undergoing surgery. We conducted a&#xD;
      previous study that showed our treatment bundle is highly effective.&#xD;
&#xD;
      Our current study planned to examine patterns/rate of S. aureus transmission to improve&#xD;
      feedback widespread implementation of the perioperative infection prevention program at Iowa.&#xD;
&#xD;
      The purpose of this study is to assess the fidelity of the set of interventions in&#xD;
      controlling perioperative S. aureus and to provide data feedback via surveillance involving&#xD;
      epidemiology of transmission for system optimization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The operating room schedule will be reviewed each day by the research assistant.&#xD;
&#xD;
      At the start of each case, the technician will obtain an OR PathTrac kit and will fill out&#xD;
      required card indicating the OR number, the surgery date, and the type of surgery. The cards&#xD;
      will be placed back into the kit. Sample collection will be directed via use of the kit. The&#xD;
      first sample is the adjustable pressure-limiting valve and agent dial of the machine before&#xD;
      patient entry (measures terminal cleaning), then provider (attending and assistant) hands&#xD;
      after they enter but before patient interaction, then the provider nose and mouth after&#xD;
      induction of anesthesia and patient stabilization, then provider hands, then same&#xD;
      environmental sites, then provider sites again, then stopcock.&#xD;
&#xD;
      A transmission event will be defined as detection of S. aureus pathogens among 2 distinct,&#xD;
      epidemiologically-related reservoirs within a surveillance unit. The software platform will&#xD;
      process transmission dynamics in order to continually summarize the epidemiology of S. aureus&#xD;
      transmission, with results updated daily as case-pair data is continually entered into the&#xD;
      program. This information will be continually displayed to identify the most common reservoir&#xD;
      of origin, the most common transmission locations (vectors), and involvement of key portals&#xD;
      of entry (stopcocks). These will become improvement targets with feedback provided via&#xD;
      automated failure mode analysis reports. The research assistant will use the reports to&#xD;
      continually optimize the interventions during the observational period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Hospital didn't use perioperative infection control bundle so study wasn't applicable.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Perioperative transmission of S. aureus</measure>
    <time_frame>24 hours</time_frame>
    <description>S. aureus transmission event</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Perioperative Transmission</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      At the start of each case, the technician will obtain an OR PathTrac kit and will fill out&#xD;
      required card indicating the OR number, the surgery date, and the type of surgery. The cards&#xD;
      will be placed back into the kit. Sample collection will be directed via use of the kit. The&#xD;
      first sample is the adjustable pressure-limiting valve and agent dial of the machine before&#xD;
      patient entry (measures terminal cleaning), then provider (attending and assistant) hands&#xD;
      after they enter but before patient interaction, then the provider nose and mouth after&#xD;
      induction of anesthesia and patient stabilization, then provider hands, then same&#xD;
      environmental sites, then provider sites again, then stopcock.&#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) patient undergoing surgery requiring anesthesia and&#xD;
             placement of a peripheral and/or central intravenous catheter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old, Shellfish, iodine, chlorhexidine allergies, no anesthesia and/or&#xD;
             placement of peripheral and/or central intravenous catheter required&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Randyt W Loftus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</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>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 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>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Request for information must be submitted as a proposal for PI review. Not before 2 years. Use subject to PI review</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>2 years from study completion</ipd_time_frame>
    <ipd_access_criteria>A written proposal submitted to PI for review</ipd_access_criteria>
  </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/NCT04449705
org study id: 202006248
nct id: NCT04449705
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical site infections increase patient morbidity and healthcare costs. The Centers for
      Disease Control and Prevention emphasizes improved basic preventive measures to reduce
      bacterial transmission and infections for patients undergoing surgery. We conducted a
      previous study that showed our treatment bundle is highly effective.

      Our current study planned to examine patterns/rate of S. aureus transmission to improve
      feedback widespread implementation of the perioperative infection prevention program at Iowa.

      The purpose of this study is to assess the fidelity of the set of interventions in
      controlling perioperative S. aureus and to provide data feedback via surveillance involving
      epidemiology of transmission for system optimization.
The operating room schedule will be reviewed each day by the research assistant.

      At the start of each case, the technician will obtain an OR PathTrac kit and will fill out
      required card indicating the OR number, the surgery date, and the type of surgery. The cards
      will be placed back into the kit. Sample collection will be directed via use of the kit. The
      first sample is the adjustable pressure-limiting valve and agent dial of the machine before
      patient entry (measures terminal cleaning), then provider (attending and assistant) hands
      after they enter but before patient interaction, then the provider nose and mouth after
      induction of anesthesia and patient stabilization, then provider hands, then same
      environmental sites, then provider sites again, then stopcock.

      A transmission event will be defined as detection of S. aureus pathogens among 2 distinct,
      epidemiologically-related reservoirs within a surveillance unit. The software platform will
      process transmission dynamics in order to continually summarize the epidemiology of S. aureus
      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 assistant will use the reports to
      continually optimize the interventions during the observational period.
observational model: Case-Only
time perspective: Prospective
measure: Perioperative transmission of S. aureus
time frame: 24 hours
description: S. aureus transmission event
At the start of each case, the technician will obtain an OR PathTrac kit and will fill out
      required card indicating the OR number, the surgery date, and the type of surgery. The cards
      will be placed back into the kit. Sample collection will be directed via use of the kit. The
      first sample is the adjustable pressure-limiting valve and agent dial of the machine before
      patient entry (measures terminal cleaning), then provider (attending and assistant) hands
      after they enter but before patient interaction, then the provider nose and mouth after
      induction of anesthesia and patient stabilization, then provider hands, then same
      environmental sites, then provider sites again, then stopcock.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
last name: Randyt W Loftus, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Randy Loftus
investigator title: Principle Investigator
mesh term: Infections
sharing ipd: Yes
ipd description: Request for information must be submitted as a proposal for PI review. Not before 2 years. Use subject to PI review
ipd info type: Study Protocol
ipd time frame: 2 years from study completion
ipd access criteria: A written proposal submitted to PI for review