<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/NCT01665963</url>
  </required_header>
  <id_info>
    <org_study_id>0042-12-HYMC</org_study_id>
    <nct_id>NCT01665963</nct_id>
  </id_info>
  <brief_title>Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients receiving oral anticoagulation or anti-platelet therapy are at high risk of hematoma&#xD;
      after device implantation. This study intends to examine the efficacy of the TopClosure(c)&#xD;
      System in wound healing in these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of TopClosure(c) System</measure>
    <time_frame>10 days</time_frame>
    <description>Outside surgeon (blinded) will determine whether wound has healed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>TopClosure(c) Treated Wound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pressure Bandage using the TopClosure(C) System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Wound Closure Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pressure Bandage</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TopClosure(c) System</intervention_name>
    <arm_group_label>TopClosure(c) Treated Wound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pressure Bandage</intervention_name>
    <arm_group_label>Traditional Wound Closure Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients treated with anticoagulant therapy&#xD;
&#xD;
          -  Patients treated with antiplatelet therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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_contact>
    <last_name>Mark Kazatsker, MD</last_name>
    <phone>972-4-6304656</phone>
    <email>markk@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Mark Kazatsker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</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>Wounds and Injuries</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/NCT01665963
org study id: 0042-12-HYMC
nct id: NCT01665963
lead sponsor: 
has dmc: Yes
Patients receiving oral anticoagulation or anti-platelet therapy are at high risk of hematoma
      after device implantation. This study intends to examine the efficacy of the TopClosure(c)
      System in wound healing in these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Efficacy of TopClosure(c) System
time frame: 10 days
description: Outside surgeon (blinded) will determine whether wound has healed
arm group label: TopClosure(c) Treated Wound
arm group type: Active Comparator
description: Pressure Bandage using the TopClosure(C) System
arm group label: Traditional Wound Closure Treatment
arm group type: Active Comparator
description: Pressure Bandage
intervention type: Device
intervention name: TopClosure(c) System
arm group label: TopClosure(c) Treated Wound
intervention type: Device
intervention name: Pressure Bandage
arm group label: Traditional Wound Closure Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Kazatsker, MD
phone: 972-4-6304656
email: markk@hy.health.gov.il
facility: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Wounds and Injuries