<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/NCT02252562</url>
  </required_header>
  <id_info>
    <org_study_id>D13081</org_study_id>
    <nct_id>NCT02252562</nct_id>
  </id_info>
  <brief_title>Hand Hygiene and Hospital Acquired Infections</brief_title>
  <official_title>Reduction in 30-Day Postoperative Healthcare-Associated Infections Through Use of a Novel Hand Hygiene System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sage Products, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public&#xD;
      health concerns that impact all areas of healthcare. Further work is needed to better&#xD;
      understand these healthcare issues so that effective preventive measures can be developed.&#xD;
&#xD;
      The investigators have developed and validated an experimental model for studying the risk&#xD;
      factors for bacterial cross contamination in the surgical operating room. The investigators&#xD;
      have confirmed in our previous work that intraoperative bacterial transmission events occur&#xD;
      frequently both within and between surgical cases and that these transmission events are&#xD;
      linked to 30-day postoperative HCAIs and increased patient mortality.&#xD;
&#xD;
      In response, the investigators have implemented various strategies designed to bacterial&#xD;
      transmission in the operating room, including anesthesia provider hand hygiene compliance.&#xD;
      The investigators' recent work in the intensive care unit suggests that the hand hygiene&#xD;
      system the investigators have previously studied could be further optimized.&#xD;
&#xD;
      The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene&#xD;
      system enhanced with novel wireless technology designed to facilitate real-time group and&#xD;
      individual performance feedback.&#xD;
&#xD;
      The investigators hypothesize that the use of this system will increase hourly hand&#xD;
      decontamination events of anesthesia and circulating nurse providers and reduce 30-day&#xD;
      postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay&#xD;
      duration, and hospital re-admission rates, and mortality(secondary outcomes).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public&#xD;
      health concerns that impact all healthcare arenas. Further work is indicated to better&#xD;
      understand these healthcare issues in order that effective preventive measures can be&#xD;
      developed.&#xD;
&#xD;
      The investigators have developed and validated an experimental model for studying the&#xD;
      mechanisms, risk factors for, and implications of bacterial cross contamination in the&#xD;
      surgical operating room. The investigators have confirmed through use of this model that&#xD;
      intraoperative bacterial transmission events occur frequently within and between operative&#xD;
      cases and that these transmission events are linked to 30-day postoperative HCAIs and to&#xD;
      increased patient mortality. In response, the investigators have implemented and evaluated&#xD;
      various strategies designed to target risk factors for intraoperative bacterial transmission&#xD;
      events including anesthesia provider hand hygiene compliance, improved handling and design of&#xD;
      intravascular catheters, and improved environmental decontamination of high-risk objects.&#xD;
      While these focused strategies have been successful in reducing transmission events and the&#xD;
      incidence of 30-day postoperative infections, the investigators' recent work in the intensive&#xD;
      care unit suggests that the hand hygiene system the investigators studied could be further&#xD;
      optimized. The investigators now propose to evaluate the effectiveness of a multimodal hand&#xD;
      hygiene system enhanced with novel wireless technology designed to facilitate real-time group&#xD;
      and individual performance feedback, two evidence-based educational interventions, in&#xD;
      reducing 30-day postoperative HCAIs (primary outcome) and intraoperative bacterial&#xD;
      transmission events, hospital stay duration, and hospital re-admission rates (secondary&#xD;
      outcomes).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Postoperative Healthcare Acquired Infections</measure>
    <time_frame>30-day after surgery</time_frame>
    <description>Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Re-admission Rates</measure>
    <time_frame>Within 30 days of discharge</time_frame>
    <description>Readmission to the hospital within 30 days of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within 30 Days of discharge</time_frame>
    <description>Patient Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Duration</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Duration of Hospital Stay</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hand Hygiene Events Per Hour Utilizing the Device</measure>
    <time_frame>During active OR cases</time_frame>
    <description>The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3256</enrollment>
  <condition>Complication of Surgical Procedure</condition>
  <arm_group>
    <arm_group_label>Standard practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Personal hand hygiene device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sage Personal Hand Hygiene System</intervention_name>
    <description>Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
    <arm_group_label>Personal hand hygiene device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Operating room environments involving adult patients undergoing general anesthesia,&#xD;
             according to usual practice, for elective or urgent and emergent orthopedic, plastic,&#xD;
             neurosurgical, cardiothoracic, urological, general abdominal, gynecological, vascular,&#xD;
             or ear/nose/and throat surgical procedures&#xD;
&#xD;
          2. Requirement of a peripheral and/or central intravenous catheter&#xD;
&#xD;
        Surgical inclusion procedures were selected because they captured the majority of 30-day&#xD;
        postoperative infections in a prior multi-center study that we conducted across three major&#xD;
        academic medical centers [3].&#xD;
&#xD;
        The investigators will [randomize by the day in order to ensure that the treatment and&#xD;
        control arms maintain their integrity and to facilitate an environment conducive to&#xD;
        behavior change.] The investigators anticipate that the randomization strategy will allow&#xD;
        equal distribution of urgent and emergent patients in the treatment and control groups.&#xD;
        Patients with a prior infection and/or preexisting decolonization will be included and will&#xD;
        be expected to be equally distributed between study groups given the randomized study&#xD;
        design. For HCAI analysis, only new infection sites and/or a different organism of&#xD;
        infection will be considered a new HCAI, per NHSN definitions (see below). The&#xD;
        investigators realize that decolonization procedures have the capacity to reduce the effect&#xD;
        size, and as such, we have appropriately adjusted the sample size (see statistical&#xD;
        section).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pediatric patients&#xD;
&#xD;
          2. Lack of an intravenous catheter&#xD;
&#xD;
          3. Pregnant&#xD;
&#xD;
          4. A surgical procedure outside of the classes listed above&#xD;
&#xD;
          5. Adjustments on the day of surgery given the following considerations:&#xD;
&#xD;
               -  Provider allergy/intolerance to 64% alcohol: In the case where the primary&#xD;
                  anesthesia provider conveys a prior allergy to 64% alcohol and/or a history of&#xD;
                  significant contact dermatitis, the operating room will be excluded from&#xD;
                  enrollment. If a primary anesthesia provider develops an allergy and/or contact&#xD;
                  dermatitis during the study period, this will be documented, and operating rooms&#xD;
                  assigned to the primary anesthesia provider for future cases will be excluded.&#xD;
                  The expectation will be that all key providers working in operating rooms&#xD;
                  randomized to the intervention will participate in utilization of the device. If&#xD;
                  an operating room is randomized and a provider subsequently refuses to&#xD;
                  participate for any reason, the operating room will be excluded from the primary&#xD;
                  analysis but included in an intention-to-treat analysis. An additional operating&#xD;
                  room will be randomized for each such occurrence.&#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>Stephen O Heard, MD</last_name>
    <role>Study Chair</role>
    <affiliation>UMASS Memorial Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.</citation>
    <PMID>19352154</PMID>
  </reference>
  <reference>
    <citation>Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.</citation>
    <PMID>18719437</PMID>
  </reference>
  <results_reference>
    <citation>Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.</citation>
    <PMID>27267310</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>September 11, 2018</results_first_submitted>
  <results_first_submitted_qc>February 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2019</results_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew Koff</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Hand hygiene</keyword>
  <keyword>Hospital acquired infections (HAI)</keyword>
  <keyword>Healthcare acquired infections (HCAI)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Operating room enrollment occurred from September 30, 2013, to June 17, 2014, at Dartmouth-Hitchcock Medical Center and from January 8, 2014, to August 21, 2014, at UMass Memorial Medical Center. Five to 10 operating rooms were enrolled Monday-Friday for each of 20 working days per month at each site.</recruitment_details>
      <pre_assignment_details>The randomization unit was the operating room (OR); not the patient or provider. Clinicians were educated on the purpose of the study and utilized standard practice or hand hygiene device based on the ORs. 316 clinicians utilizing the personal hand hygiene device were followed for assessment, but not enrolled.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Practice</title>
          <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
        </group>
        <group group_id="P2">
          <title>Personal Hand Hygiene Device</title>
          <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1620"/>
                <participants group_id="P2" count="1636"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1620"/>
                <participants group_id="P2" count="1636"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline characteristics are the patients who were seen in the operating rooms. Clinicians were not enrolled in the study and baseline data was not collected.</population>
      <group_list>
        <group group_id="B1">
          <title>Standard Practice</title>
          <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
        </group>
        <group group_id="B2">
          <title>Personal Hand Hygiene Device</title>
          <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1620"/>
            <count group_id="B2" value="1636"/>
            <count group_id="B3" value="3256"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.29" spread="16.4"/>
                    <measurement group_id="B2" value="56.75" spread="16.6"/>
                    <measurement group_id="B3" value="57.02" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="814"/>
                    <measurement group_id="B2" value="785"/>
                    <measurement group_id="B3" value="1599"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="806"/>
                    <measurement group_id="B2" value="851"/>
                    <measurement group_id="B3" value="1657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1620"/>
                    <measurement group_id="B2" value="1636"/>
                    <measurement group_id="B3" value="3256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Postoperative Healthcare Acquired Infections</title>
        <description>Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.</description>
        <time_frame>30-day after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Practice</title>
            <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
          </group>
          <group group_id="O2">
            <title>Personal Hand Hygiene Device</title>
            <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Postoperative Healthcare Acquired Infections</title>
          <description>Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1620"/>
                <count group_id="O2" value="1636"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.</non_inferiority_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Re-admission Rates</title>
        <description>Readmission to the hospital within 30 days of discharge</description>
        <time_frame>Within 30 days of discharge</time_frame>
        <population>Data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Practice</title>
            <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
          </group>
          <group group_id="O2">
            <title>Personal Hand Hygiene Device</title>
            <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Re-admission Rates</title>
          <description>Readmission to the hospital within 30 days of discharge</description>
          <population>Data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>Patient Mortality</description>
        <time_frame>Within 30 Days of discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Practice</title>
            <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
          </group>
          <group group_id="O2">
            <title>Personal Hand Hygiene Device</title>
            <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>Patient Mortality</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1620"/>
                <count group_id="O2" value="1636"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Duration</title>
        <description>Duration of Hospital Stay</description>
        <time_frame>30 days after surgery</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Practice</title>
            <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
          </group>
          <group group_id="O2">
            <title>Personal Hand Hygiene Device</title>
            <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Duration</title>
          <description>Duration of Hospital Stay</description>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hand Hygiene Events Per Hour Utilizing the Device</title>
        <description>The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.</description>
        <time_frame>During active OR cases</time_frame>
        <population>A control arm was not tabulated as the control group did not utilize the study device.</population>
        <group_list>
          <group group_id="O1">
            <title>Clinicians</title>
            <description>Clinicians who were observed in for the Treatment arm utilizing the study device</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Hygiene Events Per Hour Utilizing the Device</title>
          <description>The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.</description>
          <population>A control arm was not tabulated as the control group did not utilize the study device.</population>
          <units>hand decontamination event per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="316"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days postoperative</time_frame>
      <desc>Adverse events related to the study outcome measures (Health-care-associated infections) were collected for patients only. AE's were not collected for clinicians.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Practice</title>
          <description>Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)</description>
        </group>
        <group group_id="E2">
          <title>Personal Hand Hygiene Device</title>
          <description>Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),&#xD;
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1620"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="1636"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1620"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1636"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1620"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1636"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Matthew D. Koff, MD Staff Physician, Anesthesiology</name_or_title>
      <organization>Dartmouth-Hitchcock Medical Center</organization>
      <phone>(603) 650-5922</phone>
      <email>Matthew.D.Koff@hitchcock.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02252562
org study id: D13081
nct id: NCT02252562
lead sponsor: 
collaborator: 
has dmc: Yes
Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public
      health concerns that impact all areas of healthcare. Further work is needed to better
      understand these healthcare issues so that effective preventive measures can be developed.

      The investigators have developed and validated an experimental model for studying the risk
      factors for bacterial cross contamination in the surgical operating room. The investigators
      have confirmed in our previous work that intraoperative bacterial transmission events occur
      frequently both within and between surgical cases and that these transmission events are
      linked to 30-day postoperative HCAIs and increased patient mortality.

      In response, the investigators have implemented various strategies designed to bacterial
      transmission in the operating room, including anesthesia provider hand hygiene compliance.
      The investigators' recent work in the intensive care unit suggests that the hand hygiene
      system the investigators have previously studied could be further optimized.

      The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene
      system enhanced with novel wireless technology designed to facilitate real-time group and
      individual performance feedback.

      The investigators hypothesize that the use of this system will increase hourly hand
      decontamination events of anesthesia and circulating nurse providers and reduce 30-day
      postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay
      duration, and hospital re-admission rates, and mortality(secondary outcomes).
Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public
      health concerns that impact all healthcare arenas. Further work is indicated to better
      understand these healthcare issues in order that effective preventive measures can be
      developed.

      The investigators have developed and validated an experimental model for studying the
      mechanisms, risk factors for, and implications of bacterial cross contamination in the
      surgical operating room. The investigators have confirmed through use of this model that
      intraoperative bacterial transmission events occur frequently within and between operative
      cases and that these transmission events are linked to 30-day postoperative HCAIs and to
      increased patient mortality. In response, the investigators have implemented and evaluated
      various strategies designed to target risk factors for intraoperative bacterial transmission
      events including anesthesia provider hand hygiene compliance, improved handling and design of
      intravascular catheters, and improved environmental decontamination of high-risk objects.
      While these focused strategies have been successful in reducing transmission events and the
      incidence of 30-day postoperative infections, the investigators' recent work in the intensive
      care unit suggests that the hand hygiene system the investigators studied could be further
      optimized. The investigators now propose to evaluate the effectiveness of a multimodal hand
      hygiene system enhanced with novel wireless technology designed to facilitate real-time group
      and individual performance feedback, two evidence-based educational interventions, in
      reducing 30-day postoperative HCAIs (primary outcome) and intraoperative bacterial
      transmission events, hospital stay duration, and hospital re-admission rates (secondary
      outcomes).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Postoperative Healthcare Acquired Infections
time frame: 30-day after surgery
description: Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.
measure: Hospital Re-admission Rates
time frame: Within 30 days of discharge
description: Readmission to the hospital within 30 days of discharge
measure: Mortality
time frame: Within 30 Days of discharge
description: Patient Mortality
measure: Hospital Duration
time frame: 30 days after surgery
description: Duration of Hospital Stay
measure: Hand Hygiene Events Per Hour Utilizing the Device
time frame: During active OR cases
description: The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.
arm group label: Standard practice
arm group type: No Intervention
description: Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
arm group label: Personal hand hygiene device
arm group type: Experimental
description: Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),
intervention type: Device
intervention name: Sage Personal Hand Hygiene System
description: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
arm group label: Personal hand hygiene device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen O Heard, MD
role: Study Chair
affiliation: UMASS Memorial Medical Center
facility: 
facility: 
country: United States
citation: Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.
PMID: 19352154
citation: Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.
PMID: 18719437
citation: Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.
PMID: 27267310
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Matthew Koff
investigator title: Assistant Professor of Anesthesiology
mesh term: Infections
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 