<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/NCT02237287</url>
  </required_header>
  <id_info>
    <org_study_id>2010-MD-0007</org_study_id>
    <nct_id>NCT02237287</nct_id>
  </id_info>
  <brief_title>Combination of Taliderm® and Vacuum-assisted Closure (VAC) for Treatment of Pressure Ulcers</brief_title>
  <official_title>Combination of Taliderm® and VAC for Treatment of Pressure Ulcers - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marine Polymer Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The wound healing promoting effect of negative wound pressure therapies (NWPT)&#xD;
      takes place at the wound foam interface. Implementation of bioactive substances at this site&#xD;
      represents a major research area for the development of future NWPT devices.&#xD;
&#xD;
      Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices&#xD;
      with or without the implementation of a thin interface of poly-N-acetyl glucosamine&#xD;
      nanofibers (sNAG) was studied in a prospective randomized clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Open label study part reduced from n=10 to n=6 because of insufficient number of patients under&#xD;
    antiaggregation.&#xD;
  </why_stopped>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing</measure>
    <time_frame>up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound Healing characteristics</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Evaluation of granulation tissue formation in study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing characteristics</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Evaluation of wound epithelialization in study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing characteristics</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Evaluation of wound contraction in study groups</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Wounds</condition>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>wound dressing with VAC</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>After wound debridement wounds are treated for 2 weeks with VAC dressing alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wound dressing with VAC and sNAG under Antiaggregation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wound dressing with VAC and sNAG without antiaggregation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>wound dressing with VAC and sNAG without antiaggregation</intervention_name>
    <arm_group_label>wound dressing with VAC and sNAG under Antiaggregation</arm_group_label>
    <arm_group_label>wound dressing with VAC and sNAG without antiaggregation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>wound dressing with VAC</intervention_name>
    <arm_group_label>wound dressing with VAC</arm_group_label>
    <arm_group_label>wound dressing with VAC and sNAG under Antiaggregation</arm_group_label>
    <arm_group_label>wound dressing with VAC and sNAG without antiaggregation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>wound dressing with VAC and sNAG under Antiaggregation</intervention_name>
    <arm_group_label>wound dressing with VAC and sNAG under Antiaggregation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischial/sacral Pressure ulcer between 4 and 15cm diameter&#xD;
&#xD;
          -  Greater than or equal to 18 years of age&#xD;
&#xD;
          -  Ability to obtain informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Connective tissue disorders&#xD;
&#xD;
          -  Immunosuppression, Hemodialysis, Steroids&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Sepsis&#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>Dirk J. Schaefer, Prof.Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swiss Paraplegic Centre Nottwil</name>
      <address>
        <city>Nottwil</city>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 28, 2015</last_update_submitted>
  <last_update_submitted_qc>September 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_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/NCT02237287
org study id: 2010-MD-0007
nct id: NCT02237287
lead sponsor: 
collaborator: 
has dmc: Yes
Background: The wound healing promoting effect of negative wound pressure therapies (NWPT)
      takes place at the wound foam interface. Implementation of bioactive substances at this site
      represents a major research area for the development of future NWPT devices.

      Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices
      with or without the implementation of a thin interface of poly-N-acetyl glucosamine
      nanofibers (sNAG) was studied in a prospective randomized clinical trial.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: up to 1 year
measure: Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing
time frame: up to 1 year
measure: Wound Healing characteristics
time frame: up to 1 year
description: Evaluation of granulation tissue formation in study groups
measure: Wound Healing characteristics
time frame: up to 1 year
description: Evaluation of wound epithelialization in study groups
measure: Wound Healing characteristics
time frame: up to 1 year
description: Evaluation of wound contraction in study groups
arm group label: wound dressing with VAC
arm group type: Sham Comparator
description: After wound debridement wounds are treated for 2 weeks with VAC dressing alone
arm group label: wound dressing with VAC and sNAG under Antiaggregation
arm group type: Other
description: In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
arm group label: wound dressing with VAC and sNAG without antiaggregation
arm group type: Experimental
description: In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
intervention type: Other
intervention name: wound dressing with VAC and sNAG without antiaggregation
arm group label: wound dressing with VAC and sNAG under Antiaggregation
arm group label: wound dressing with VAC and sNAG without antiaggregation
intervention type: Procedure
intervention name: wound dressing with VAC
arm group label: wound dressing with VAC
arm group label: wound dressing with VAC and sNAG under Antiaggregation
arm group label: wound dressing with VAC and sNAG without antiaggregation
intervention type: Drug
intervention name: wound dressing with VAC and sNAG under Antiaggregation
arm group label: wound dressing with VAC and sNAG under Antiaggregation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dirk J. Schaefer, Prof.Dr.
role: Study Director
affiliation: University Hospital, Basel, Switzerland
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer