<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/NCT02984527</url>
  </required_header>
  <id_info>
    <org_study_id>SDUSF-2015-65/R1 - (205)</org_study_id>
    <nct_id>NCT02984527</nct_id>
  </id_info>
  <brief_title>Traditional Bed Baths Versus Disposable Wet Wipes</brief_title>
  <official_title>Comparison of Skin Swaps From Traditional Bed Baths Versus Disposable Wet Wipes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital of Southern Jutland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Purpose of the study is to compare the effectiveness on microbiological counts from skin&#xD;
      swaps after wash with water and soap or wet wipes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a crossover clinical trial where the effect of two interventions is compared on&#xD;
      the same subject.&#xD;
&#xD;
      The two interventions are:&#xD;
&#xD;
        -  Intimate hygiene with water and soap&#xD;
&#xD;
        -  Intimate hygiene with prepackaged disposable wet wipes&#xD;
&#xD;
      Null hypothesis: Same effectiveness to reduce microbiological counts on skin&#xD;
&#xD;
      Alternative hypothesis: Significant different effectiveness to reduce microbiological counts&#xD;
      on skin&#xD;
&#xD;
      Each individual receives the two interventions in random order. The effect of the&#xD;
      interventions on microbiological counts on the patients skin is evaluated on the same&#xD;
      patient.&#xD;
&#xD;
      A crossover trial requires half the number of participants and reduces confounding factors.&#xD;
&#xD;
      All participants receive a sequence of the two different interventions. But there is a&#xD;
      sufficient gab between the two interventions to ensure a washout period and avoid a crossover&#xD;
      effect. In this study this is 12-24 hours.&#xD;
&#xD;
      The study uses block randomization, without intra block correlation to achieve allocation&#xD;
      balance over time.&#xD;
&#xD;
      Furthermore it may prevent some predictable allocation.&#xD;
&#xD;
      Microbiological sampling with moistened swaps and aseptic techniques, sterile equipment and&#xD;
      sterile recovery medium (Stewarts Medium) are used to obtain skin samples from the patients&#xD;
      before and after intimate hygiene with water and soap and wet wipes.&#xD;
&#xD;
      Differences in microbiological skin counts will be compared (delta values) before and after&#xD;
      the two interventions and between interventions.&#xD;
&#xD;
      Data will be blinded during microbiological count and statistical analyses.&#xD;
&#xD;
      Analyses:&#xD;
&#xD;
      Data are structured in CASTOR and will be stored in a secure Team Collaboration Software Tool&#xD;
      (SharePoint).&#xD;
&#xD;
      Descriptive analysis including mean, median, confidence interval, standard deviation, and&#xD;
      standard error.&#xD;
&#xD;
      Statistical analyses will be performed using STATA. Test of differences will be performed by&#xD;
      simple t- test or Wilcoxon sign rank test, depending on the distribution of the data. A&#xD;
      multiple regression analysis including possible confounders will be considered.&#xD;
&#xD;
      Inclusion of 68 patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>microbiological counts on skin before and after interventions</measure>
    <time_frame>two consecutive days</time_frame>
    <description>microbiological counts from skin swaps before and after washing with water and soap and before and after washing with disposable wipes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Intimate Hygiene</condition>
  <arm_group>
    <arm_group_label>water and soap first day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intimate hygiene performed with water and soap first day and disposable wet wipes second day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>disposable wet wipes first day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intimate hygiene performed with wet wipes first day and water and soap second day</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>wet wipes</intervention_name>
    <description>intimate hygiene with disposable wet wipes</description>
    <arm_group_label>disposable wet wipes first day</arm_group_label>
    <arm_group_label>water and soap first day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>water and soap</intervention_name>
    <description>Intimate hygiene with water and soap</description>
    <arm_group_label>disposable wet wipes first day</arm_group_label>
    <arm_group_label>water and soap first day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who need intimate hygiene&#xD;
&#xD;
          -  Admitted for minimum two days&#xD;
&#xD;
          -  Understand oral information&#xD;
&#xD;
          -  And apple to sign written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diarrhea&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Dying&#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>Jette Primdahl, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital of Southern Jutland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Southern Jutland</name>
      <address>
        <city>Aabenraa</city>
        <state>Jutland</state>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Pia Lysdal Veje</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984527
org study id: SDUSF-2015-65/R1 - (205)
nct id: NCT02984527
lead sponsor: 
collaborator: 
has dmc: No
The Purpose of the study is to compare the effectiveness on microbiological counts from skin
      swaps after wash with water and soap or wet wipes.
The study is a crossover clinical trial where the effect of two interventions is compared on
      the same subject.

      The two interventions are:

        -  Intimate hygiene with water and soap

        -  Intimate hygiene with prepackaged disposable wet wipes

      Null hypothesis: Same effectiveness to reduce microbiological counts on skin

      Alternative hypothesis: Significant different effectiveness to reduce microbiological counts
      on skin

      Each individual receives the two interventions in random order. The effect of the
      interventions on microbiological counts on the patients skin is evaluated on the same
      patient.

      A crossover trial requires half the number of participants and reduces confounding factors.

      All participants receive a sequence of the two different interventions. But there is a
      sufficient gab between the two interventions to ensure a washout period and avoid a crossover
      effect. In this study this is 12-24 hours.

      The study uses block randomization, without intra block correlation to achieve allocation
      balance over time.

      Furthermore it may prevent some predictable allocation.

      Microbiological sampling with moistened swaps and aseptic techniques, sterile equipment and
      sterile recovery medium (Stewarts Medium) are used to obtain skin samples from the patients
      before and after intimate hygiene with water and soap and wet wipes.

      Differences in microbiological skin counts will be compared (delta values) before and after
      the two interventions and between interventions.

      Data will be blinded during microbiological count and statistical analyses.

      Analyses:

      Data are structured in CASTOR and will be stored in a secure Team Collaboration Software Tool
      (SharePoint).

      Descriptive analysis including mean, median, confidence interval, standard deviation, and
      standard error.

      Statistical analyses will be performed using STATA. Test of differences will be performed by
      simple t- test or Wilcoxon sign rank test, depending on the distribution of the data. A
      multiple regression analysis including possible confounders will be considered.

      Inclusion of 68 patients
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: microbiological counts on skin before and after interventions
time frame: two consecutive days
description: microbiological counts from skin swaps before and after washing with water and soap and before and after washing with disposable wipes
arm group label: water and soap first day
arm group type: Active Comparator
description: Intimate hygiene performed with water and soap first day and disposable wet wipes second day
arm group label: disposable wet wipes first day
arm group type: Active Comparator
description: Intimate hygiene performed with wet wipes first day and water and soap second day
intervention type: Device
intervention name: wet wipes
description: intimate hygiene with disposable wet wipes
arm group label: disposable wet wipes first day
arm group label: water and soap first day
intervention type: Device
intervention name: water and soap
description: Intimate hygiene with water and soap
arm group label: disposable wet wipes first day
arm group label: water and soap first day
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jette Primdahl, PhD
role: Study Chair
affiliation: Hospital of Southern Jutland
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Pia Lysdal Veje
investigator title: PhD student
sharing ipd: No