<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/NCT02195310</url>
  </required_header>
  <id_info>
    <org_study_id>KCI.2013.Prevena.01</org_study_id>
    <nct_id>NCT02195310</nct_id>
  </id_info>
  <brief_title>The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.</brief_title>
  <official_title>The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KCI Europe Holding B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS)&#xD;
      versus standard wound care for the incision in subjects undergoing a sternal midline incision&#xD;
      (sternotomy). The subjects targetted for the study are at high risk for surgical&#xD;
      complications (like infections) around the environment of the incision.&#xD;
&#xD;
      The study is conducted in The Netherlands, Germany and Austria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Prevena™ IMS is intended to manage the environment of closed surgically incision and&#xD;
      surrounding intact skin for patients with an increased risk for developing post-operative&#xD;
      complications such as infection.The purpose of this study is to compare the use of Prevena™&#xD;
      Incision Management System (IMS) versus standard wound care for the incision in subjects&#xD;
      undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are&#xD;
      at high risk for surgical complications (like infections) around the environment of the&#xD;
      incision.&#xD;
&#xD;
      The Prevena™ IMS is a small portable device, which consists of a mild vacuum unit that&#xD;
      delivers negative pressure and a dressing that is intended for use over closed incisions&#xD;
      after surgery. It is used for a minimum of 4 days up to a maximum of 7 days. This system is&#xD;
      commercially available and has a CE mark, which means that it is approved for the use on the&#xD;
      European market. It is intended to be applied immediately post sternotomy surgery on a closed&#xD;
      clean incision.&#xD;
&#xD;
      The results of this study could contribute to a better and faster healing of the incision.&#xD;
&#xD;
      The study is conducted in The Netherlands, Germany and Austria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    due to futility&#xD;
  </why_stopped>
  <start_date type="Actual">November 12, 2013</start_date>
  <completion_date type="Actual">October 17, 2016</completion_date>
  <primary_completion_date type="Actual">August 15, 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.</measure>
    <time_frame>30 ± 4 days</time_frame>
    <description>The SSI rate (in %) was calculated for each treatment arm as follows:&#xD;
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">342</enrollment>
  <condition>Surgical Site Occurences After Sternotomy</condition>
  <condition>Wound Infection</condition>
  <arm_group>
    <arm_group_label>Prevena™ Incision Management System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional sterile wound dressings</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prevena™ Incision Management System</intervention_name>
    <description>Prevena™ Incision Management System is used after sternotomy on the closed incision</description>
    <arm_group_label>Prevena™ Incision Management System</arm_group_label>
    <other_name>Prevena Peel &amp; Place</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional sterile wound dressings</intervention_name>
    <description>Conventional sterile wound dressings are placed after sternotomy on the closed incision</description>
    <arm_group_label>Conventional sterile wound dressings</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is male or female and 18 years of age or older&#xD;
&#xD;
          -  Is scheduled for elective cardiac surgery for which a median sternotomy is needed&#xD;
             (including coronary artery bypass grafting (CABG), valvular repair or replacement with&#xD;
             or without CABG). Elective surgery is defined as planned surgery a minimum of 24 hours&#xD;
             before the procedure.&#xD;
&#xD;
          -  Is capable of providing informed consent, which must be obtained prior to any&#xD;
             study-related procedures&#xD;
&#xD;
          -  Is willing and able to adhere to the study visit schedule and other protocol&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is pregnant&#xD;
&#xD;
          -  The use of Prevena post surgery is contra indicated per investigator's discretion&#xD;
&#xD;
          -  Has a systemic infection at the time of surgery: systemic infection is diagnosed on&#xD;
             the basis of clinical signs of sepsis with or without a positive culture of an&#xD;
             organism from the bloodstream&#xD;
&#xD;
          -  Has a remote body site infection at the time of surgery (including dental, urinary or&#xD;
             skin soft tissue infections)&#xD;
&#xD;
          -  Is known to have a current nasal swab positive for methicillin-resistant&#xD;
             staphylococcus aureus (MRSA)&#xD;
&#xD;
          -  Has a known allergy or hypersensitivity to silver, or drape materials that contain&#xD;
             acrylic adhesives&#xD;
&#xD;
          -  Has a requirement for competing wound therapy and procedures.&#xD;
&#xD;
          -  Any concomitant therapies (including other NPWT treatment) or procedures deviating&#xD;
             from the clinical standard incision treatment or with investigational device at the&#xD;
             location of the sternotomy (e.g. use of NPWT at other location of the body is allowed)&#xD;
&#xD;
          -  Any other therapies or procedures that, in the opinion of the treating physician,&#xD;
             would affect or influence postoperative wound stability or healing&#xD;
&#xD;
          -  Is simultaneously participating in another interventional trial&#xD;
&#xD;
          -  Requires use of liquid skin adhesives or glues during skin closure&#xD;
&#xD;
          -  Is known to be serology positive for hepatitis B, hepatitis C or HIV&#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>Thanasie Markou, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isala</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universitat Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center Salzburg GmbH</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien, Universitätsklinik für Chirurgie</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westfälische Wilhelms-Universität Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg</name>
      <address>
        <city>Nurnberg</city>
        <zip>90471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <state>Overijssel</state>
        <zip>8000 GK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stichting St. Antonius ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht</state>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxcentrum Research BV, Erasmus University Medical Center Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>December 4, 2017</results_first_submitted>
  <results_first_submitted_qc>June 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2019</results_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sternotomy</keyword>
  <keyword>Surgical site Occurences</keyword>
  <keyword>Negative Pressure Wound Therapy</keyword>
  <keyword>Surgical Site Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prevena™ Incision Management System</title>
          <description>Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use&#xD;
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision</description>
        </group>
        <group group_id="P2">
          <title>Conventional Sterile Wound Dressings</title>
          <description>Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).&#xD;
Conventional sterile wound dressings are placed after sternotomy on the closed incision</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="153"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prevena™ Incision Management System</title>
          <description>Subjects will receive sternal wound treatment in the operating room with Prevena™ IMS according to the intended use&#xD;
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision</description>
        </group>
        <group group_id="B2">
          <title>Conventional Sterile Wound Dressings</title>
          <description>Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze)&#xD;
Conventional sterile wound dressings are placed after sternotomy on the closed incision</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="173"/>
            <count group_id="B2" value="169"/>
            <count group_id="B3" value="342"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.1" spread="9.279"/>
                    <measurement group_id="B2" value="65.45" spread="10.304"/>
                    <measurement group_id="B3" value="66.29" spread="9.819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.</title>
        <description>The SSI rate (in %) was calculated for each treatment arm as follows:&#xD;
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event</description>
        <time_frame>30 ± 4 days</time_frame>
        <population>Full Analysis Set: Included Subjects in the ITT Analysis Set that had no important disqualifying protocol deviations, who met the inclusion/exclusion criteria, and had completed SSI evaluations at visit 5 (Follow-up Day 30). Subjects were analyzed in the arm to which they were treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Prevena™ Incision Management System</title>
            <description>Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use&#xD;
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision</description>
          </group>
          <group group_id="O2">
            <title>Conventional Sterile Wound Dressings</title>
            <description>Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).&#xD;
Conventional sterile wound dressings are placed after sternotomy on the closed incision</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.</title>
          <description>The SSI rate (in %) was calculated for each treatment arm as follows:&#xD;
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event</description>
          <population>Full Analysis Set: Included Subjects in the ITT Analysis Set that had no important disqualifying protocol deviations, who met the inclusion/exclusion criteria, and had completed SSI evaluations at visit 5 (Follow-up Day 30). Subjects were analyzed in the arm to which they were treated.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7007</p_value>
            <method>Fisher Exact Test (2-sided)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Prevena™ Incision Management System</title>
          <description>Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use&#xD;
Prevena™ Incision Management System: Prevena™ Incision Management System is used after sternotomy on the closed incision</description>
        </group>
        <group group_id="E2">
          <title>Conventional Sterile Wound Dressings</title>
          <description>Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).&#xD;
Conventional sterile wound dressings: Conventional sterile wound dressings are placed after sternotomy on the closed incision</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Tamponade</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Ventricular Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Right Ventricular Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Bundle Branch Block Left</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cardiac Valve Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Left Ventricular Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Low Cardiac Output Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Sick Sinus Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Ventricular Flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Electromechanical Dissociation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amaurosis Fugax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Intestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Large Intestine Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multi-Organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Impaired Healing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Sudden Cardiac Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Sudden Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Postoperative Infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Groin Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Mediastinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Catheter Site Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Acute Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Mediastinal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Post Procedural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Dislocation of Sternum</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Rib Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Vascular Procedure Complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Wound Complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Wound Secretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Iatrogenic Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Postoperative Thoracic Procedure Complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Spinal Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Hypercreatininaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Apnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Rehabilitation Therapy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Removal of Foreign Body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemodynamic Instability</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Vascular Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="85" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="96" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Postoperative Infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Post Procedural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wound Drainage</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="173"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Inclusion criteria were broad, expected event rates in the control group proved to be incorrect. Acelity plans to continue studying those at high risk for postoperative wound complications (e.g BMI&gt;35).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Daniela Weichert, PhD</name_or_title>
      <organization>KCI Europe Holding B.V.</organization>
      <phone>+353 (0) 860436155</phone>
      <email>daniela.weichert@acelity.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02195310
org study id: KCI.2013.Prevena.01
nct id: NCT02195310
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS)
      versus standard wound care for the incision in subjects undergoing a sternal midline incision
      (sternotomy). The subjects targetted for the study are at high risk for surgical
      complications (like infections) around the environment of the incision.

      The study is conducted in The Netherlands, Germany and Austria.
The Prevena™ IMS is intended to manage the environment of closed surgically incision and
      surrounding intact skin for patients with an increased risk for developing post-operative
      complications such as infection.The purpose of this study is to compare the use of Prevena™
      Incision Management System (IMS) versus standard wound care for the incision in subjects
      undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are
      at high risk for surgical complications (like infections) around the environment of the
      incision.

      The Prevena™ IMS is a small portable device, which consists of a mild vacuum unit that
      delivers negative pressure and a dressing that is intended for use over closed incisions
      after surgery. It is used for a minimum of 4 days up to a maximum of 7 days. This system is
      commercially available and has a CE mark, which means that it is approved for the use on the
      European market. It is intended to be applied immediately post sternotomy surgery on a closed
      clean incision.

      The results of this study could contribute to a better and faster healing of the incision.

      The study is conducted in The Netherlands, Germany and Austria.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
time frame: 30 ± 4 days
description: The SSI rate (in %) was calculated for each treatment arm as follows:
SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
arm group label: Prevena™ Incision Management System
arm group type: Experimental
description: Subjects will receive sternal wound treatment in the operating room using Prevena™ Incision Management System according to the intended use
arm group label: Conventional sterile wound dressings
arm group type: Active Comparator
description: Subjects will receive standard conventional wound therapy (SCWT) placed in the operating room, defined as using conventional sterile wound dressings (gauze).
intervention type: Device
intervention name: Prevena™ Incision Management System
description: Prevena™ Incision Management System is used after sternotomy on the closed incision
arm group label: Prevena™ Incision Management System
other name: Prevena Peel & Place
intervention type: Device
intervention name: Conventional sterile wound dressings
description: Conventional sterile wound dressings are placed after sternotomy on the closed incision
arm group label: Conventional sterile wound dressings
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thanasie Markou, MD, PhD
role: Principal Investigator
affiliation: Isala
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Netherlands
country: Czech Republic
responsible party type: Sponsor
mesh term: Wound Infection
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Inclusion criteria were broad, expected event rates in the control group proved to be incorrect. Acelity plans to continue studying those at high risk for postoperative wound complications (e.g BMI>35).
point of contact: 