<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/NCT01698372</url>
  </required_header>
  <id_info>
    <org_study_id>KCI VAC Study</org_study_id>
    <nct_id>NCT01698372</nct_id>
  </id_info>
  <brief_title>Negative Pressure Dressing After Saphenous Vein Harvest</brief_title>
  <official_title>Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the effectiveness of negative pressure wound therapy (using the VAC&#xD;
      Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary&#xD;
      Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention&#xD;
      may decrease the incidence of wound infection and non-infectious wound complications. It may&#xD;
      decrease wound discomfort and improve mobility and functional recovery of the leg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline ASEPSIS score of wound healing at 6 weeks.</measure>
    <time_frame>Baseline and 6 weeks</time_frame>
    <description>The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total score of pain level.</measure>
    <time_frame>Baseline and 6 weeks</time_frame>
    <description>Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Complication of Coronary Artery Bypass Graft</condition>
  <condition>Wound Complication</condition>
  <arm_group>
    <arm_group_label>Prevena device (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional dressing (Group B)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prevena device (Group A)</intervention_name>
    <description>This portable device is applied to initiate negative pressure therapy to a wound site.</description>
    <arm_group_label>Prevena device (Group A)</arm_group_label>
    <other_name>Prevena Incision Management System</other_name>
    <other_name>Prevena 125</other_name>
    <other_name>PRE1001.S Prevena Incision Kit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting for elective or semi-elective isolated first-time CABG surgery&#xD;
             with harvesting of the greater saphenous vein.&#xD;
&#xD;
          -  Must be 18 years or older.&#xD;
&#xD;
          -  Must live with one hour driving distance from Calgary.&#xD;
&#xD;
          -  Must provide written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous CABG surgery or previous lower leg surgical intervention.&#xD;
&#xD;
          -  In emergent need for surgery.&#xD;
&#xD;
          -  Have severe peripheral vascular disease.&#xD;
&#xD;
          -  Do not speak and read the English language.&#xD;
&#xD;
          -  Have dialysis-dependent renal failure.&#xD;
&#xD;
          -  Require chronic steroids.&#xD;
&#xD;
          -  Unable to return to clinic for follow-up due to functional or cognitive impairment.&#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>Paul Fedak, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Libin Cardiovascular Institute, Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Paul Fedak</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiac surgery.</keyword>
  <keyword>Wound healing.</keyword>
  <keyword>Leg wound infection.</keyword>
  <keyword>Wound care.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT01698372
org study id: KCI VAC Study
nct id: NCT01698372
lead sponsor: 
collaborator: 
has dmc: No
This study will test the effectiveness of negative pressure wound therapy (using the VAC
      Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary
      Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention
      may decrease the incidence of wound infection and non-infectious wound complications. It may
      decrease wound discomfort and improve mobility and functional recovery of the leg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Change from baseline ASEPSIS score of wound healing at 6 weeks.
time frame: Baseline and 6 weeks
description: The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.
measure: Total score of pain level.
time frame: Baseline and 6 weeks
description: Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.
arm group label: Prevena device (Group A)
arm group type: Experimental
description: Group A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.
arm group label: Conventional dressing (Group B)
arm group type: No Intervention
description: Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.
intervention type: Device
intervention name: Prevena device (Group A)
description: This portable device is applied to initiate negative pressure therapy to a wound site.
arm group label: Prevena device (Group A)
other name: Prevena Incision Management System
other name: Prevena 125
other name: PRE1001.S Prevena Incision Kit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Fedak, MD, PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Paul Fedak
investigator title: Associate Professor
mesh term: Coronary Artery Disease