<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/NCT02241005</url>
  </required_header>
  <id_info>
    <org_study_id>TWIPES</org_study_id>
    <secondary_id>NCI-2015-00114</secondary_id>
    <nct_id>NCT02241005</nct_id>
  </id_info>
  <brief_title>Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci</brief_title>
  <official_title>A Randomized Controlled Trial of the Safety and Efficacy of Theraworx Bath Wipes in the Reduction of Skin Colonization With Vancomycin-Resistant Enterococci Compared to Standard Bath Wipes in Children Undergoing Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Avadim Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Jude Children's Research Hospital</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>
      Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality&#xD;
      and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT).&#xD;
      These infections are often caused by a patient's own microbial flora. Hence reduction of&#xD;
      microbes in the skin could lessen the risk of contamination of central venous catheters,&#xD;
      Central Line Associated Blood-Stream Infections (CLABSI), and bacteremia due to compromise of&#xD;
      skin integrity.&#xD;
&#xD;
      Theraworx™ (herein referred to as experimental wipes) is a self-drying, leave on cleansing&#xD;
      agent that combines a specialized surfactant with skin healthy ingredients, including aloe,&#xD;
      allantoin, vitamin E, and silver, which is the main antimicrobial ingredient. It can be used&#xD;
      on all parts of the body including burns, abraded skin, and on patients with skin&#xD;
      graft-versus-host-disease (GVHD). It is user friendly and obviates the risk of antimicrobial&#xD;
      resistance. Microbiologic studies have shown several log fold reduction of bacteria including&#xD;
      vancomycin-resistant enterococci, carbapenem resistant Escherichia coli, and activity against&#xD;
      Staphylococcus aureus, Enterococcus faecalis, Clostridium difficile, Candida albicans, and&#xD;
      viruses including influenza A and Herpes Simplex. There is no data regarding the use of&#xD;
      Theraworx™ (experimental) bath wipes in children or the HSCT population.&#xD;
&#xD;
      Researchers at St. Jude Children's Research Hospital want to learn if daily bathing with&#xD;
      experimental bath wipes will be well tolerated and associated with reduction in microbial&#xD;
      skin colonization in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to receive either a daily bath with the experimental bath&#xD;
      wipes, or the standard bath wipes, beginning on the day of admission, and to be used once&#xD;
      daily for a period of 60 days post-HSCT. In the first 12 patients randomized to the&#xD;
      experimental wipes, if no patient has grade IV skin toxicity that is attributable to the&#xD;
      experimental wipes, then the trial will continue until a total of 250 evaluable participants&#xD;
      have been enrolled. Assessment of skin colonization will be performed before admission, at&#xD;
      the time of discharge, and post-HSCT.&#xD;
&#xD;
      Randomization will take place at the time the participant is enrolled and will be performed&#xD;
      by staff within the Nursing Research Department. Participants will be assigned to either&#xD;
      experimental or standard bath wipes in a 1:1 ratio. Randomization may be stratified for&#xD;
      nature of transplant (autologous vs. allogeneic); and in the case of allogeneic transplant&#xD;
      stratified for total body irradiation vs. no total body irradiation. The investigators,&#xD;
      practicing clinician and the clinical research staff will remain blinded to the treatment.&#xD;
&#xD;
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        -  Assess the safety of the experimental bath wipes in 12 patients.&#xD;
&#xD;
        -  Assess the skin colonization with vancomycin-resistant enterococci in patients using the&#xD;
           experimental wipes compared to standard bath wipes.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
        -  Assess skin colonization with bacterial pathogens.&#xD;
&#xD;
        -  Compare the skin colonization with multi-drug resistant organisms (MRDO) and central&#xD;
           line-associated bloodstream infection (CLABSI) rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2014</start_date>
  <completion_date type="Actual">September 19, 2017</completion_date>
  <primary_completion_date type="Actual">September 19, 2017</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients using Theraworx™ wipes who experience any grade IV skin toxicity</measure>
    <time_frame>Through date of discharge from inpatient unit, or maximum of 60 days after study enrollment</time_frame>
    <description>In the first 12 evaluable patients in the Theraworx™ arm of the randomized controlled trial, we will closely monitor for the safety of experimental bath wipes. Since no grade IV toxicity attributable to the wipes is expected in the standard bath wipes arm, if at any time during the study in the first 12 evaluable participants in the experimental arm we observe one patient with grade IV skin rash toxicity in the experimental arm which is attributable to the experimental bath wipes , then the study will be stopped and the use of experimental bath wipes for HSCT patients will be considered unsafe. If the use of experimental bath wipes for HSCT patients is considered feasible, the trial will continue. 95% Blyth-Still-Casella will be provided.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with vancomycin-resistant enterococci (VRE) colonization by study arm</measure>
    <time_frame>At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)</time_frame>
    <description>The proportion of patients with VRE colonization at enrollment and at the time of initial discharge from the inpatient unit in the groups of patients using the experimental and standard bath wipes and their 95% confidence intervals (CI) will be provided. Fisher's exact test will be used to test for the null hypothesis that two proportions are equal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of different bacterial species in participants by study arm</measure>
    <time_frame>At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)</time_frame>
    <description>Summary statistics for the number of different bacterial species in groups of patients using the experimental and standard bath wipes will be provided. Exact Wilcoxon rank sum test will be used to compare the medians of the numbers of different bacterial species in two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with multi-drug resistant organisms (MRDO) and central line-associated bloodstream infection (CLABSI)</measure>
    <time_frame>At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)</time_frame>
    <description>The proportions of patients with MRDO and CLABSI in the groups of patients using the experimental wipes and standard bath wipes and their 95% Blyth-Still-Casella (BSC) CIs will be provided. Fisher's exact test will be used to test for the null hypothesis that two proportions are equal.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <condition>Vancomycin-Resistant Enterococci</condition>
  <arm_group>
    <arm_group_label>Theraworx™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are randomized to use the Theraworx™ bath wipes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are randomized to use standard bath wipes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Theraworx™ bath wipes</intervention_name>
    <description>Theraworx™ bath wipes will be supplied in packaging similar to the standard bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.</description>
    <arm_group_label>Theraworx™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard bath wipes</intervention_name>
    <description>Standard bath wipes will be supplied in packaging similar to the Theraworx™ bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.</description>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than or equal to 21 years of age.&#xD;
&#xD;
          -  Scheduled to undergo either autologous or allogeneic hematopoietic stem cell&#xD;
             transplant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant/Parent/Legally authorized representative (LAR) unwilling to give written&#xD;
             informed consent.&#xD;
&#xD;
          -  (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted&#xD;
             within 14 days prior to enrollment).&#xD;
&#xD;
          -  (Female only) Breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margie Kjellin, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health-care associated infection</keyword>
  <keyword>Skin integrity</keyword>
  <keyword>Antimicrobial resistance</keyword>
  <!-- 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/NCT02241005
org study id: TWIPES
secondary id: NCI-2015-00114
nct id: NCT02241005
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality
      and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT).
      These infections are often caused by a patient's own microbial flora. Hence reduction of
      microbes in the skin could lessen the risk of contamination of central venous catheters,
      Central Line Associated Blood-Stream Infections (CLABSI), and bacteremia due to compromise of
      skin integrity.

      Theraworx™ (herein referred to as experimental wipes) is a self-drying, leave on cleansing
      agent that combines a specialized surfactant with skin healthy ingredients, including aloe,
      allantoin, vitamin E, and silver, which is the main antimicrobial ingredient. It can be used
      on all parts of the body including burns, abraded skin, and on patients with skin
      graft-versus-host-disease (GVHD). It is user friendly and obviates the risk of antimicrobial
      resistance. Microbiologic studies have shown several log fold reduction of bacteria including
      vancomycin-resistant enterococci, carbapenem resistant Escherichia coli, and activity against
      Staphylococcus aureus, Enterococcus faecalis, Clostridium difficile, Candida albicans, and
      viruses including influenza A and Herpes Simplex. There is no data regarding the use of
      Theraworx™ (experimental) bath wipes in children or the HSCT population.

      Researchers at St. Jude Children's Research Hospital want to learn if daily bathing with
      experimental bath wipes will be well tolerated and associated with reduction in microbial
      skin colonization in this population.
Participants will be randomized to receive either a daily bath with the experimental bath
      wipes, or the standard bath wipes, beginning on the day of admission, and to be used once
      daily for a period of 60 days post-HSCT. In the first 12 patients randomized to the
      experimental wipes, if no patient has grade IV skin toxicity that is attributable to the
      experimental wipes, then the trial will continue until a total of 250 evaluable participants
      have been enrolled. Assessment of skin colonization will be performed before admission, at
      the time of discharge, and post-HSCT.

      Randomization will take place at the time the participant is enrolled and will be performed
      by staff within the Nursing Research Department. Participants will be assigned to either
      experimental or standard bath wipes in a 1:1 ratio. Randomization may be stratified for
      nature of transplant (autologous vs. allogeneic); and in the case of allogeneic transplant
      stratified for total body irradiation vs. no total body irradiation. The investigators,
      practicing clinician and the clinical research staff will remain blinded to the treatment.

      PRIMARY OBJECTIVES:

        -  Assess the safety of the experimental bath wipes in 12 patients.

        -  Assess the skin colonization with vancomycin-resistant enterococci in patients using the
           experimental wipes compared to standard bath wipes.

      SECONDARY OBJECTIVES:

        -  Assess skin colonization with bacterial pathogens.

        -  Compare the skin colonization with multi-drug resistant organisms (MRDO) and central
           line-associated bloodstream infection (CLABSI) rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Proportion of patients using Theraworx™ wipes who experience any grade IV skin toxicity
time frame: Through date of discharge from inpatient unit, or maximum of 60 days after study enrollment
description: In the first 12 evaluable patients in the Theraworx™ arm of the randomized controlled trial, we will closely monitor for the safety of experimental bath wipes. Since no grade IV toxicity attributable to the wipes is expected in the standard bath wipes arm, if at any time during the study in the first 12 evaluable participants in the experimental arm we observe one patient with grade IV skin rash toxicity in the experimental arm which is attributable to the experimental bath wipes , then the study will be stopped and the use of experimental bath wipes for HSCT patients will be considered unsafe. If the use of experimental bath wipes for HSCT patients is considered feasible, the trial will continue. 95% Blyth-Still-Casella will be provided.
measure: Proportion of patients with vancomycin-resistant enterococci (VRE) colonization by study arm
time frame: At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)
description: The proportion of patients with VRE colonization at enrollment and at the time of initial discharge from the inpatient unit in the groups of patients using the experimental and standard bath wipes and their 95% confidence intervals (CI) will be provided. Fisher's exact test will be used to test for the null hypothesis that two proportions are equal
measure: Number of different bacterial species in participants by study arm
time frame: At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)
description: Summary statistics for the number of different bacterial species in groups of patients using the experimental and standard bath wipes will be provided. Exact Wilcoxon rank sum test will be used to compare the medians of the numbers of different bacterial species in two groups.
measure: Proportion of patients with multi-drug resistant organisms (MRDO) and central line-associated bloodstream infection (CLABSI)
time frame: At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)
description: The proportions of patients with MRDO and CLABSI in the groups of patients using the experimental wipes and standard bath wipes and their 95% Blyth-Still-Casella (BSC) CIs will be provided. Fisher's exact test will be used to test for the null hypothesis that two proportions are equal.
arm group label: Theraworx™
arm group type: Active Comparator
description: Participants are randomized to use the Theraworx™ bath wipes.
arm group label: Standard
arm group type: Active Comparator
description: Participants are randomized to use standard bath wipes.
intervention type: Other
intervention name: Theraworx™ bath wipes
description: Theraworx™ bath wipes will be supplied in packaging similar to the standard bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
arm group label: Theraworx™
intervention type: Other
intervention name: Standard bath wipes
description: Standard bath wipes will be supplied in packaging similar to the Theraworx™ bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
arm group label: Standard
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Margie Kjellin, RN
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor