<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/NCT02258412</url>
  </required_header>
  <id_info>
    <org_study_id>EM-05-013218</org_study_id>
    <nct_id>NCT02258412</nct_id>
  </id_info>
  <brief_title>Evaluation of Two Hand Hygiene Products in ICUs</brief_title>
  <official_title>Evaluation of Antimicrobial Efficacy of Two Hand Hygiene Products in ICUs Using Hand Prints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the immediate antimicrobial efficacy and persistence of two hand&#xD;
      hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on&#xD;
      hands using the hand print method. It is hypothesized that the product containing&#xD;
      Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in&#xD;
      less bacterial growth on the hand print plates. In addition, environmental monitoring for&#xD;
      cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas&#xD;
      using Rodac plates and adenosine triphosphate tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crossover study with 50 Health care workers using each product with a minimum of 3 days in&#xD;
      between. Products will be applied twice as per manufacturer's instructions for a Healthcare&#xD;
      Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected&#xD;
      after exposure to environmental contaminants in the common areas. Hand prints will also be&#xD;
      collected from one hand of 60 patients cared for by a participating Health Care Worker and&#xD;
      gloved hand of Health Care Worker. All media contain neutralizers to inactivate active&#xD;
      ingredients in each product and on surfaces. Each hand print plate's area of growth will be&#xD;
      measured for Colony Forming Units using computerized software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas</measure>
    <time_frame>On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas</time_frame>
    <description>Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Hand Hygiene Effectiveness</condition>
  <arm_group>
    <arm_group_label>Alcohol hand sanitizer foam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hand antiseptic with CHG and alcohol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hand antiseptic with CHG and alcohol</intervention_name>
    <description>HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.</description>
    <arm_group_label>hand antiseptic with CHG and alcohol</arm_group_label>
    <other_name>Avagard CHG Hand Antiseptic with Moisturizers</other_name>
    <other_name>Purell Advanced Instant Hand Sanitizer Foam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alcohol hand sanitizer foam</intervention_name>
    <description>Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day</description>
    <arm_group_label>Alcohol hand sanitizer foam</arm_group_label>
    <other_name>Purell Instant Sanitizer Foam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HCW willing to participate in the study&#xD;
&#xD;
          -  HCW willing to use non-Triclosan soap when soap is necessary throughout the study&#xD;
&#xD;
          -  HCW who will don gloves prior to ICU patient room entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any CHG -containing products ( liquid hand soap, Sage wipes) on the ICU 72&#xD;
             hours prior to study initiation and throughout study&#xD;
&#xD;
          -  HCW with patient bandage or other dressing on palm(s)&#xD;
&#xD;
          -  Known sensitivity or allergy to CHG or alcohols in hand hygiene products&#xD;
&#xD;
          -  Known sensitivity or allergy to the following components: Lecithin, Polysorbate&#xD;
             80,Trypticase Soy Agar, sodium bisulfate, sodium thioglycollate, sodium thiosulfate&#xD;
&#xD;
          -  History of skin allergies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abhishek Deshpande, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>January 31, 2017</results_first_submitted>
  <results_first_submitted_qc>May 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2017</results_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antimicrobial</keyword>
  <keyword>efficacy</keyword>
  <keyword>hand</keyword>
  <keyword>hygiene</keyword>
  <keyword>bacteria</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
    <mesh_term>Hand Sanitizers</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment took place from October 2014-January 2015 at 3 MICUs within the same hospital</recruitment_details>
      <pre_assignment_details>Subjects were enrolled on the same day as treatment; subjects were required to meet inclusion/exclusion criteria to qualify for enrollment</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Alcohol + CHG First</title>
          <description>Healthcare workers who received product with alcohol + CHG prior to product with alcohol only</description>
        </group>
        <group group_id="P2">
          <title>Alcohol Only First</title>
          <description>Healthcare workers who received product with alcohol only prior to product with alcohol + CHG</description>
        </group>
        <group group_id="P3">
          <title>Patient</title>
          <description>Patients received no treatment, but were cared for by healthcare workers who enrolled in the study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Alcohol + CHG First</title>
          <description>Healthcare workers who received product with alcohol + CHG prior to product with alcohol only</description>
        </group>
        <group group_id="B2">
          <title>Alcohol Only First</title>
          <description>Healthcare workers who received product with alcohol only prior to product with alcohol + CHG</description>
        </group>
        <group group_id="B3">
          <title>Patient</title>
          <description>Patients received no treatment, but were cared for by healthcare workers who enrolled in the study</description>
        </group>
        <group group_id="B4">
          <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="26"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="61"/>
            <count group_id="B4" value="112"/>
          </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="NA" spread="NA">Subject age was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B2" value="NA" spread="NA">Subject age was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B3" value="NA" spread="NA">Subject age was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B4" value="NA" spread="NA">Subject age was not recorded as it is not relevant to the study outcome</measurement>
                  </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="NA">Subject gender was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B2" value="NA">Subject gender was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B3" value="NA">Subject gender was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B4" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Subject gender was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B2" value="NA">Subject gender was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B3" value="NA">Subject gender was not recorded as it is not relevant to the study outcome</measurement>
                    <measurement group_id="B4" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </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="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas</title>
        <description>Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.</description>
        <time_frame>On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alcohol Hand Sanitizer Foam</title>
            <description>Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.&#xD;
Alcohol hand sanitizer foam: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day</description>
          </group>
          <group group_id="O2">
            <title>Hand Antiseptic With CHG and Alcohol</title>
            <description>Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.&#xD;
hand antiseptic with CHG and alcohol: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas</title>
          <description>Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.</description>
          <units>log(10) transformed CFU</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" lower_limit="2.07" upper_limit="2.27"/>
                    <measurement group_id="O2" value="1.81" lower_limit="1.67" upper_limit="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Alcohol + CHG First</title>
          <description>Healthcare workers who received product with alcohol + CHG prior to product with alcohol only</description>
        </group>
        <group group_id="E2">
          <title>Alcohol Only First</title>
          <description>Healthcare workers who received product with alcohol only prior to product with alcohol + CHG</description>
        </group>
        <group group_id="E3">
          <title>Patient</title>
          <description>Patients received no treatment, but were cared for by healthcare workers who enrolled in the study</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="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research Specialist</name_or_title>
      <organization>3M Health Care Business</organization>
      <phone>651-736-1578</phone>
      <email>mdavid@mmm.com</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/NCT02258412
org study id: EM-05-013218
nct id: NCT02258412
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the immediate antimicrobial efficacy and persistence of two hand
      hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on
      hands using the hand print method. It is hypothesized that the product containing
      Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in
      less bacterial growth on the hand print plates. In addition, environmental monitoring for
      cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas
      using Rodac plates and adenosine triphosphate tests.
Crossover study with 50 Health care workers using each product with a minimum of 3 days in
      between. Products will be applied twice as per manufacturer's instructions for a Healthcare
      Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected
      after exposure to environmental contaminants in the common areas. Hand prints will also be
      collected from one hand of 60 patients cared for by a participating Health Care Worker and
      gloved hand of Health Care Worker. All media contain neutralizers to inactivate active
      ingredients in each product and on surfaces. Each hand print plate's area of growth will be
      measured for Colony Forming Units using computerized software.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas
time frame: On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas
description: Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.
arm group label: Alcohol hand sanitizer foam
arm group type: Active Comparator
description: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.
arm group label: hand antiseptic with CHG and alcohol
arm group type: Active Comparator
description: Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.
intervention type: Drug
intervention name: hand antiseptic with CHG and alcohol
description: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.
arm group label: hand antiseptic with CHG and alcohol
other name: Avagard CHG Hand Antiseptic with Moisturizers
other name: Purell Advanced Instant Hand Sanitizer Foam
intervention type: Drug
intervention name: Alcohol hand sanitizer foam
description: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day
arm group label: Alcohol hand sanitizer foam
other name: Purell Instant Sanitizer Foam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Abhishek Deshpande, MD, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ethanol
mesh term: Anti-Infective Agents, Local
mesh term: Hand Sanitizers
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 