<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/NCT04449575</url>
  </required_header>
  <id_info>
    <org_study_id>H20007169</org_study_id>
    <nct_id>NCT04449575</nct_id>
  </id_info>
  <brief_title>Hand Eczema in the Health Care Sector</brief_title>
  <official_title>Hand Eczema in the Health Care Sector</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Bispebjerg and Frederiksberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Statens Serum Institut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Bispebjerg and Frederiksberg</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>
      This project aims to investigate the prevalence of bacterial colonization and associated&#xD;
      factors in health care workers with hand eczema with focus on Staphylococcus aureus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups will be examined in this study: health care workers with HE and matched controls&#xD;
      invited through a questionnaire study which will be sent to approximately 4000 health care&#xD;
      workers in Capital Region. Samples from health care workers with and without hand eczema will&#xD;
      be collected after obtaining their written informed consent. Collection of samples: Swabs&#xD;
      will be rubbed on the skin for 30 seconds on lesional and non-lesional skin on the dominating&#xD;
      hand and from the nostrils. The swabs will immediately be stored in -80 C° (research biobank)&#xD;
      for subsequent analysis at Statens Serum Institute.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Staphyloccous aureus presence</measure>
    <time_frame>Baseline, cross-sectional</time_frame>
    <description>Prevalence of S. aureus colonization on hands and in nose in two groups of health care workers. The swab samples will be assessed by culturing on selective S. aureus plates (chromID S. aureus; bioMerieux, Marcy l'Etoile, France) and incubated overnight at 37 °C. DNA will be purified from S. aureus isolates using the Qiagen DNeasy Blood and Tissue Purification Kit (Qiagen, Hilden, Germany).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CC-types and spa-typing</measure>
    <time_frame>Baseline, cross-sectional</time_frame>
    <description>clonal complex (CC) type and spa-types are characterizing the S. aureus. Will be correlated to departments and professions of health care workers. The S. aureus will be further characterized by spa typing, which will be performed by polymerase chain reaction and Sanger sequencing of the product. The respective CC types will be assigned from the spa type using eBURST (http://eburst.mlst.net).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Eczema Severity Index (HECSI)</measure>
    <time_frame>Baseline, cross-sectional</time_frame>
    <description>Validated severity measurement tool for hand eczema performed by the investigator. Severity will be correlated to S. aureus colonization and CC types</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Hand Eczema</condition>
  <arm_group>
    <arm_group_label>Health care workers with hand eczema</arm_group_label>
    <description>Swabs will be taken from eczema lesions on dominating hand (if possible) and nostril</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls (health care workers without hand eczema)</arm_group_label>
    <description>swabs will be taken from healthy skin on dominating hand and nostril</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>eSwabs</intervention_name>
    <description>from skin</description>
    <arm_group_label>Health care workers with hand eczema</arm_group_label>
    <arm_group_label>controls (health care workers without hand eczema)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bacteria from the skin will be sampled by eSwabs.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Health care workers from 4 hospitals in Capital Region, Denmark, with and without hand&#xD;
        eczema.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnosis of hand eczema (for group with hand eczema)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other skin diseases (in both groups)&#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>Yasemin T. Yüksel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen Bispebjerg and Frederiksberg Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tove Agner, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Copenhagen Bispebjerg and Frederiksberg Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yasemin T. Yüksel, MD</last_name>
    <phone>004522917017</phone>
    <email>yasemin.topal.yueksel@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tove Agner, MD, PhD</last_name>
    <email>tove.agner@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yasemin Topal Yüksel</name>
      <address>
        <city>Copenhagen</city>
        <state>Kbh Nv</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yasemin Yüksel, MD</last_name>
      <phone>22917017</phone>
      <email>y.topal@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Mernelius S, Carlsson E, Henricson J, Lofgren S, Lindgren PE, Ehricht R, Monecke S, Matussek A, Anderson CD. Staphylococcus aureus colonization related to severity of hand eczema. Eur J Clin Microbiol Infect Dis. 2016 Aug;35(8):1355-61. doi: 10.1007/s10096-016-2672-2. Epub 2016 May 19.</citation>
    <PMID>27193891</PMID>
  </reference>
  <reference>
    <citation>Haslund P, Bangsgaard N, Jarlov JO, Skov L, Skov R, Agner T. Staphylococcus aureus and hand eczema severity. Br J Dermatol. 2009 Oct;161(4):772-7. doi: 10.1111/j.1365-2133.2009.09353.x. Epub 2009 Jul 3.</citation>
    <PMID>19575755</PMID>
  </reference>
  <reference>
    <citation>Pittet D, Allegranzi B, Sax H, Dharan S, Pessoa-Silva CL, Donaldson L, Boyce JM; WHO Global Patient Safety Challenge, World Alliance for Patient Safety. Evidence-based model for hand transmission during patient care and the role of improved practices. Lancet Infect Dis. 2006 Oct;6(10):641-52. doi: 10.1016/S1473-3099(06)70600-4.</citation>
    <PMID>17008173</PMID>
  </reference>
  <reference>
    <citation>Brans R, Kolomanski K, Mentzel F, Vollmer U, Kaup O, John SM. Colonisation with methicillin-resistant Staphylococcus aureus and associated factors among nurses with occupational skin diseases. Occup Environ Med. 2016 Oct;73(10):670-5. doi: 10.1136/oemed-2016-103632. Epub 2016 Jun 29.</citation>
    <PMID>27358469</PMID>
  </reference>
  <reference>
    <citation>Clausen ML, Edslev SM, Norreslet LB, Sorensen JA, Andersen PS, Agner T. Temporal variation of Staphylococcus aureus clonal complexes in atopic dermatitis: a follow-up study. Br J Dermatol. 2019 Jan;180(1):181-186. doi: 10.1111/bjd.17033. Epub 2018 Oct 10.</citation>
    <PMID>30070683</PMID>
  </reference>
  <reference>
    <citation>Held E, Skoet R, Johansen JD, Agner T. The hand eczema severity index (HECSI): a scoring system for clinical assessment of hand eczema. A study of inter- and intraobserver reliability. Br J Dermatol. 2005 Feb;152(2):302-7. doi: 10.1111/j.1365-2133.2004.06305.x.</citation>
    <PMID>15727643</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Bispebjerg and Frederiksberg</investigator_affiliation>
    <investigator_full_name>Yasemin Topal Yüksel</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <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/NCT04449575
org study id: H20007169
nct id: NCT04449575
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to investigate the prevalence of bacterial colonization and associated
      factors in health care workers with hand eczema with focus on Staphylococcus aureus.
Two groups will be examined in this study: health care workers with HE and matched controls
      invited through a questionnaire study which will be sent to approximately 4000 health care
      workers in Capital Region. Samples from health care workers with and without hand eczema will
      be collected after obtaining their written informed consent. Collection of samples: Swabs
      will be rubbed on the skin for 30 seconds on lesional and non-lesional skin on the dominating
      hand and from the nostrils. The swabs will immediately be stored in -80 C° (research biobank)
      for subsequent analysis at Statens Serum Institute.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Staphyloccous aureus presence
time frame: Baseline, cross-sectional
description: Prevalence of S. aureus colonization on hands and in nose in two groups of health care workers. The swab samples will be assessed by culturing on selective S. aureus plates (chromID S. aureus; bioMerieux, Marcy l'Etoile, France) and incubated overnight at 37 °C. DNA will be purified from S. aureus isolates using the Qiagen DNeasy Blood and Tissue Purification Kit (Qiagen, Hilden, Germany).
measure: CC-types and spa-typing
time frame: Baseline, cross-sectional
description: clonal complex (CC) type and spa-types are characterizing the S. aureus. Will be correlated to departments and professions of health care workers. The S. aureus will be further characterized by spa typing, which will be performed by polymerase chain reaction and Sanger sequencing of the product. The respective CC types will be assigned from the spa type using eBURST (http://eburst.mlst.net).
measure: Hand Eczema Severity Index (HECSI)
time frame: Baseline, cross-sectional
description: Validated severity measurement tool for hand eczema performed by the investigator. Severity will be correlated to S. aureus colonization and CC types
arm group label: Health care workers with hand eczema
description: Swabs will be taken from eczema lesions on dominating hand (if possible) and nostril
arm group label: controls (health care workers without hand eczema)
description: swabs will be taken from healthy skin on dominating hand and nostril
intervention type: Other
intervention name: eSwabs
description: from skin
arm group label: Health care workers with hand eczema
arm group label: controls (health care workers without hand eczema)
Bacteria from the skin will be sampled by eSwabs.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yasemin T. Yüksel, MD
role: Principal Investigator
affiliation: University of Copenhagen Bispebjerg and Frederiksberg Hospital
last name: Tove Agner, MD, PhD
role: Study Director
affiliation: University of Copenhagen Bispebjerg and Frederiksberg Hospital
last name: Yasemin T. Yüksel, MD
phone: 004522917017
email: yasemin.topal.yueksel@regionh.dk
last name: Tove Agner, MD, PhD
email: tove.agner@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
citation: Mernelius S, Carlsson E, Henricson J, Lofgren S, Lindgren PE, Ehricht R, Monecke S, Matussek A, Anderson CD. Staphylococcus aureus colonization related to severity of hand eczema. Eur J Clin Microbiol Infect Dis. 2016 Aug;35(8):1355-61. doi: 10.1007/s10096-016-2672-2. Epub 2016 May 19.
PMID: 27193891
citation: Haslund P, Bangsgaard N, Jarlov JO, Skov L, Skov R, Agner T. Staphylococcus aureus and hand eczema severity. Br J Dermatol. 2009 Oct;161(4):772-7. doi: 10.1111/j.1365-2133.2009.09353.x. Epub 2009 Jul 3.
PMID: 19575755
citation: Pittet D, Allegranzi B, Sax H, Dharan S, Pessoa-Silva CL, Donaldson L, Boyce JM; WHO Global Patient Safety Challenge, World Alliance for Patient Safety. Evidence-based model for hand transmission during patient care and the role of improved practices. Lancet Infect Dis. 2006 Oct;6(10):641-52. doi: 10.1016/S1473-3099(06)70600-4.
PMID: 17008173
citation: Brans R, Kolomanski K, Mentzel F, Vollmer U, Kaup O, John SM. Colonisation with methicillin-resistant Staphylococcus aureus and associated factors among nurses with occupational skin diseases. Occup Environ Med. 2016 Oct;73(10):670-5. doi: 10.1136/oemed-2016-103632. Epub 2016 Jun 29.
PMID: 27358469
citation: Clausen ML, Edslev SM, Norreslet LB, Sorensen JA, Andersen PS, Agner T. Temporal variation of Staphylococcus aureus clonal complexes in atopic dermatitis: a follow-up study. Br J Dermatol. 2019 Jan;180(1):181-186. doi: 10.1111/bjd.17033. Epub 2018 Oct 10.
PMID: 30070683
citation: Held E, Skoet R, Johansen JD, Agner T. The hand eczema severity index (HECSI): a scoring system for clinical assessment of hand eczema. A study of inter- and intraobserver reliability. Br J Dermatol. 2005 Feb;152(2):302-7. doi: 10.1111/j.1365-2133.2004.06305.x.
PMID: 15727643
responsible party type: Principal Investigator
investigator affiliation: University Hospital Bispebjerg and Frederiksberg
investigator full name: Yasemin Topal Yüksel
investigator title: MD
mesh term: Eczema
sharing ipd: No