<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/NCT03007264</url>
  </required_header>
  <id_info>
    <org_study_id>NBS 14.200-CAP1</org_study_id>
    <secondary_id>NL52211.094.16</secondary_id>
    <nct_id>NCT03007264</nct_id>
  </id_info>
  <brief_title>Cold Plasma for Wound Treatment, Safety Study</brief_title>
  <official_title>Safety Assessment of Cold Gas Plasma on Intact Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association of Dutch Burn Centres</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eindhoven University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association of Dutch Burn Centres</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>
      In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin&#xD;
      of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial&#xD;
      effect will be investigated as well. The investigators expect this treatment to have a good&#xD;
      antimicrobial effect with acceptable, transient skin sensations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Control of infection and bacterial colonisation constitutes a continuing challenge in&#xD;
      patients with burns. Prevention of microbial contamination and infection is vital for burn&#xD;
      wound care as bacterial presence can result in excessive inflammatory reactions, delayed&#xD;
      re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease&#xD;
      the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has&#xD;
      been shown in vitro to kill a wide range of pathogenic bacteria.&#xD;
&#xD;
      This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn&#xD;
      wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister&#xD;
      formation, pain, itching), erythema, local skin temperature, trans epidermal water loss&#xD;
      (TEWL) and reduction of the bacterial load wil be monitored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2018</start_date>
  <completion_date type="Actual">July 26, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain</measure>
    <time_frame>before to 30 minutes after treatment</time_frame>
    <description>by using a visual analogue thermometer (VAT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>local skin reaction</measure>
    <time_frame>directly to 30 minutes after treatment</time_frame>
    <description>blister formation, itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local skin temperature</measure>
    <time_frame>before to 30 minutes after treatment</time_frame>
    <description>thermographic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>colour/pigmentation</measure>
    <time_frame>before to 30 minutes after treatment</time_frame>
    <description>erythema, redness of the skin, by using a Dermaspectrometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>trans epidermal water loss</measure>
    <time_frame>before to 30 minutes after treatment</time_frame>
    <description>barrier function of the skin by using TEWAmeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction of the bacterial load</measure>
    <time_frame>directly to 5 minutes after treatment</time_frame>
    <description>quantified with scrub wash method</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Intact Skin</condition>
  <condition>Contaminant Given to Patient</condition>
  <arm_group>
    <arm_group_label>CAP treated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>volar arm will be treated with cold atmospheric plasma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAP on bacteria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>volar arm with bacteria will be treated with cold atmospheric plasma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no CAP on bacteria</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cold Atmospheric Plasma</intervention_name>
    <description>CAP will be applied on one volar arm of volunteers for a total of 2 minutes.</description>
    <arm_group_label>CAP on bacteria</arm_group_label>
    <arm_group_label>CAP treated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to comply with the research protocol&#xD;
&#xD;
          -  No language barrier&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atopic dermatitis or other skin disease&#xD;
&#xD;
          -  Implanted electrical medical devices such cardiac pacemakers&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients with infected wounds.&#xD;
&#xD;
          -  Life-threatening cardiac conductivity abnormality&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Women of childbearing age not using contraceptive measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther Middelkoop, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Red Cross Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Association of Dutch Burn Centres</name>
      <address>
        <city>Beverwijk</city>
        <state>Noord-Holland</state>
        <zip>1942 LE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2.</citation>
    <PMID>26944583</PMID>
  </results_reference>
  <results_reference>
    <citation>Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.</citation>
    <PMID>24666170</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>August 17, 2018</last_update_submitted>
  <last_update_submitted_qc>August 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cold atmospheric plasma</keyword>
  <keyword>pain</keyword>
  <keyword>bacteria</keyword>
  <keyword>skin parameters</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 16, 2021</submitted>
    <returned>March 8, 2021</returned>
  </pending_results>
  <!-- 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/NCT03007264
org study id: NBS 14.200-CAP1
secondary id: NL52211.094.16
nct id: NCT03007264
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin
      of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial
      effect will be investigated as well. The investigators expect this treatment to have a good
      antimicrobial effect with acceptable, transient skin sensations.
Control of infection and bacterial colonisation constitutes a continuing challenge in
      patients with burns. Prevention of microbial contamination and infection is vital for burn
      wound care as bacterial presence can result in excessive inflammatory reactions, delayed
      re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease
      the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has
      been shown in vitro to kill a wide range of pathogenic bacteria.

      This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn
      wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister
      formation, pain, itching), erythema, local skin temperature, trans epidermal water loss
      (TEWL) and reduction of the bacterial load wil be monitored.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain
time frame: before to 30 minutes after treatment
description: by using a visual analogue thermometer (VAT)
measure: local skin reaction
time frame: directly to 30 minutes after treatment
description: blister formation, itching
measure: local skin temperature
time frame: before to 30 minutes after treatment
description: thermographic analysis
measure: colour/pigmentation
time frame: before to 30 minutes after treatment
description: erythema, redness of the skin, by using a Dermaspectrometer
measure: trans epidermal water loss
time frame: before to 30 minutes after treatment
description: barrier function of the skin by using TEWAmeter
measure: reduction of the bacterial load
time frame: directly to 5 minutes after treatment
description: quantified with scrub wash method
arm group label: CAP treated
arm group type: Experimental
description: volar arm will be treated with cold atmospheric plasma.
arm group label: CAP on bacteria
arm group type: Experimental
description: volar arm with bacteria will be treated with cold atmospheric plasma.
arm group label: no CAP on bacteria
arm group type: No Intervention
description: volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load.
intervention type: Device
intervention name: Cold Atmospheric Plasma
description: CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
arm group label: CAP on bacteria
arm group label: CAP treated
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Esther Middelkoop, PhD
role: Principal Investigator
affiliation: Red Cross Hospital
facility: 
country: Netherlands
citation: Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2.
PMID: 26944583
citation: Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.
PMID: 24666170
responsible party type: Sponsor
sharing ipd: No
submitted: February 16, 2021
returned: March 8, 2021