<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/NCT01717690</url>
  </required_header>
  <id_info>
    <org_study_id>BCGC-CHG-2012</org_study_id>
    <nct_id>NCT01717690</nct_id>
  </id_info>
  <brief_title>Study of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization in Complex Continuing Care</brief_title>
  <official_title>Randomized Controlled Clinical Trial of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization on Complex Continuing Care Units of Baycrest Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baycrest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baycrest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether daily bathing with 2% chlorhexidine&#xD;
      gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of&#xD;
      colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus&#xD;
      (MRSA).&#xD;
&#xD;
      Investigators postulate that daily bathing with CHG significantly reduces incidence of&#xD;
      colonization of hospitalized patients with MRSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bathing patients with 2% chlorhexidine gluconate-impregnated cloths (CHG) is an established&#xD;
      practice at Baycrest. Our previous studies have demonstrated strong MRSA-preventive&#xD;
      properties of CHG bathing practice - the rate of MRSA transmission on intervention units&#xD;
      dropped from 4.99 to 0.88 cases per 1,000 patient days - an overall rate reduction of 82%.&#xD;
&#xD;
      Although CHG will continue to be used as part of an established clinical practice in our&#xD;
      hospital, its impact on MRSA prevention merits further evaluation in complex continuing care&#xD;
      (CCC) settings endemic for MRSA. Investigators propose a cluster-randomized, prospective,&#xD;
      open-label, two-arm clinical trial (RCT) on three geographically separate, but otherwise&#xD;
      comparable, CCC units - one intervention unit using CHG, and two control units using&#xD;
      non-antiseptic cleanser. The RCT is expected to conclusively answer whether daily bathing&#xD;
      with CHG significantly reduces incidence of MRSA colonization.&#xD;
&#xD;
      By cluster randomization investigators imply randomly assigning interventions to the three&#xD;
      patient care units. Investigators propose randomization of the units as it is not feasible to&#xD;
      randomly assign the individual participants to intervention vs control arms.&#xD;
&#xD;
      For a meaningful interpretation of the RCT findings, patient populations on the three floors&#xD;
      will be compared at the beginning, during, and at the end of the study. The following&#xD;
      variables will be used to compare patient populations:&#xD;
&#xD;
        -  Colonization pressure (CP) is a measure of the MRSA reservoir on the unit. CP will be&#xD;
           calculated at the onset of the RCT and then bi-weekly (Number of MRSA patient-days × 100&#xD;
           ÷ Total Number of Patient Days).&#xD;
&#xD;
        -  Average Braden scale score (BSS) for patients on each unit is measured to predict a&#xD;
           pressure ulcer risk. It is one of the measures of patient's clinical complexity. It is&#xD;
           calculated by examining six patient criteria (sensory perception, skin moisture,&#xD;
           physical activity, mobility, nutrition, friction and shear). BSS will be calculated at&#xD;
           the onset of the RCT and then monthly.&#xD;
&#xD;
        -  Average Case Mix Index (CMI) is a value reflecting the daily relative weight of&#xD;
           resources used by an individual patient compared to a base resource level (the average&#xD;
           resource use of the patient population). The CMI value is not a dollar amount; rather it&#xD;
           is a relative value and an indirect marker of patient's clinical complexity. CMI will be&#xD;
           calculated at the onset of the RCT and then quarterly.&#xD;
&#xD;
      Patient information will be de-identified for privacy reasons, before analysis of the study&#xD;
      data - logistic regression, to compare the rates of MRSA incidence and time to MRSA&#xD;
      conversion on intervention and control units.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of MRSA colonization</measure>
    <time_frame>12 months</time_frame>
    <description>Primary outcome measure will be incidence of MRSA colonization measured through bi-weekly point-prevalence surveys on each of the three units. All new admissions and re-admissions to the units will also be screened. Protective properties of CHG bathing are expected to significantly reduce the incidence of MRSA transmission in the intervention arm, compared to control arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to MRSA conversion</measure>
    <time_frame>12 months</time_frame>
    <description>Secondary outcome measure will be time to MRSA conversion measured as the length of time it takes patients to convert from being MRSA-negative at enrollment to MRSA-positive at discharge or end of the study. Protective properties of CHG bathing are expected to significantly prolong conversion time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Staph Aureus Methicillin Resistant Colonization</condition>
  <arm_group>
    <arm_group_label>CHG antiseptic body cleanser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One randomly selected intervention unit in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with an antiseptic body cleanser (CHG).&#xD;
Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed.&#xD;
Antiseptic body cleanser - 2% Chlorhexidine Gluconate in a non-alcohol and non-alkaline base, delivered to skin surface through the bath cloths impregnated with this antiseptic solution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-antiseptic body cleanser</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Two control units in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with a non-antiseptic body cleanser (Comfort Bath ®).&#xD;
Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CHG antiseptic body cleanser</intervention_name>
    <description>The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG.</description>
    <arm_group_label>CHG antiseptic body cleanser</arm_group_label>
    <other_name>Chlorhexidine gluconate cloths</other_name>
    <other_name>Drug Identification Number (Health Canada): 02245741</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MRSA-negative (at enrollment) inpatient of Complex Continuing Care program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRSA-positive (at enrollment) inpatient of Complex Continuing Care program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chingiz Amirov, MPH, CIC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baycrest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baycrest Hospital, Complex Continuing Care program</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6A 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>February 20, 2015</last_update_submitted>
  <last_update_submitted_qc>February 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baycrest</investigator_affiliation>
    <investigator_full_name>Chingiz Amirov</investigator_full_name>
    <investigator_title>Director, Infection Prevention and Control</investigator_title>
  </responsible_party>
  <keyword>MRSA</keyword>
  <keyword>chlorhexidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
  </intervention_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/NCT01717690
org study id: BCGC-CHG-2012
nct id: NCT01717690
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether daily bathing with 2% chlorhexidine
      gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of
      colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus
      (MRSA).

      Investigators postulate that daily bathing with CHG significantly reduces incidence of
      colonization of hospitalized patients with MRSA.
Bathing patients with 2% chlorhexidine gluconate-impregnated cloths (CHG) is an established
      practice at Baycrest. Our previous studies have demonstrated strong MRSA-preventive
      properties of CHG bathing practice - the rate of MRSA transmission on intervention units
      dropped from 4.99 to 0.88 cases per 1,000 patient days - an overall rate reduction of 82%.

      Although CHG will continue to be used as part of an established clinical practice in our
      hospital, its impact on MRSA prevention merits further evaluation in complex continuing care
      (CCC) settings endemic for MRSA. Investigators propose a cluster-randomized, prospective,
      open-label, two-arm clinical trial (RCT) on three geographically separate, but otherwise
      comparable, CCC units - one intervention unit using CHG, and two control units using
      non-antiseptic cleanser. The RCT is expected to conclusively answer whether daily bathing
      with CHG significantly reduces incidence of MRSA colonization.

      By cluster randomization investigators imply randomly assigning interventions to the three
      patient care units. Investigators propose randomization of the units as it is not feasible to
      randomly assign the individual participants to intervention vs control arms.

      For a meaningful interpretation of the RCT findings, patient populations on the three floors
      will be compared at the beginning, during, and at the end of the study. The following
      variables will be used to compare patient populations:

        -  Colonization pressure (CP) is a measure of the MRSA reservoir on the unit. CP will be
           calculated at the onset of the RCT and then bi-weekly (Number of MRSA patient-days × 100
           ÷ Total Number of Patient Days).

        -  Average Braden scale score (BSS) for patients on each unit is measured to predict a
           pressure ulcer risk. It is one of the measures of patient's clinical complexity. It is
           calculated by examining six patient criteria (sensory perception, skin moisture,
           physical activity, mobility, nutrition, friction and shear). BSS will be calculated at
           the onset of the RCT and then monthly.

        -  Average Case Mix Index (CMI) is a value reflecting the daily relative weight of
           resources used by an individual patient compared to a base resource level (the average
           resource use of the patient population). The CMI value is not a dollar amount; rather it
           is a relative value and an indirect marker of patient's clinical complexity. CMI will be
           calculated at the onset of the RCT and then quarterly.

      Patient information will be de-identified for privacy reasons, before analysis of the study
      data - logistic regression, to compare the rates of MRSA incidence and time to MRSA
      conversion on intervention and control units.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of MRSA colonization
time frame: 12 months
description: Primary outcome measure will be incidence of MRSA colonization measured through bi-weekly point-prevalence surveys on each of the three units. All new admissions and re-admissions to the units will also be screened. Protective properties of CHG bathing are expected to significantly reduce the incidence of MRSA transmission in the intervention arm, compared to control arms.
measure: Time to MRSA conversion
time frame: 12 months
description: Secondary outcome measure will be time to MRSA conversion measured as the length of time it takes patients to convert from being MRSA-negative at enrollment to MRSA-positive at discharge or end of the study. Protective properties of CHG bathing are expected to significantly prolong conversion time.
arm group label: CHG antiseptic body cleanser
arm group type: Active Comparator
description: One randomly selected intervention unit in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with an antiseptic body cleanser (CHG).
Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed.
Antiseptic body cleanser - 2% Chlorhexidine Gluconate in a non-alcohol and non-alkaline base, delivered to skin surface through the bath cloths impregnated with this antiseptic solution.
arm group label: Non-antiseptic body cleanser
arm group type: No Intervention
description: Two control units in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with a non-antiseptic body cleanser (Comfort Bath ®).
Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed.
intervention type: Drug
intervention name: CHG antiseptic body cleanser
description: The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG.
arm group label: CHG antiseptic body cleanser
other name: Chlorhexidine gluconate cloths
other name: Drug Identification Number (Health Canada): 02245741
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chingiz Amirov, MPH, CIC
role: Principal Investigator
affiliation: Baycrest
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Baycrest
investigator full name: Chingiz Amirov
investigator title: Director, Infection Prevention and Control
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Anti-Infective Agents, Local