<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/NCT03283787</url>
  </required_header>
  <id_info>
    <org_study_id>CA2016-001</org_study_id>
    <nct_id>NCT03283787</nct_id>
  </id_info>
  <brief_title>Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries</brief_title>
  <official_title>A Single Site Randomized, Clinical Trial Comparing the Concomitant Use of MicroMatrix® With Cytal™ Wound Matrix 2-Layer to Standard of Care in Patients With Stage 3 or 4 Pressure Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Vincent's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Integra LifeSciences Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 &amp;&#xD;
      4 pressure ulcers using ACell products.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A three arm, parallel-design, randomized study comparing 2 experimental arms to a single&#xD;
      control arm. The primary comparison will be Group 1 (MicroMatrix® and ACell Cytal™ Wound&#xD;
      Matrix 2-Layer vs. Group 3 (NPWT) to determine if Group 1 is superior to Group 3. NPWT is the&#xD;
      standard of care (SOC) for patients with Stage 3 or 4 pressure ulcers and is the active&#xD;
      control arm for the study.&#xD;
&#xD;
      A secondary comparison will be conducted comparing Group 2 (MicroMatrix® and ACell Cytal™&#xD;
      Wound Matrix 2-Layer plus NPWT) vs. Group 3 (NPWT) to determine if Group 2 is superior to&#xD;
      Group 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 23, 2019</completion_date>
  <primary_completion_date type="Actual">September 25, 2019</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>Incidence of Complete Epithelialization</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Complete Wound Epithelization</measure>
    <time_frame>12 weeks</time_frame>
    <description>Time to complete wound epithelization between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Wound Epithelization</measure>
    <time_frame>12 weeks</time_frame>
    <description>Rate of wound epithelization between groups</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pressure Ulcers Stage III</condition>
  <condition>Pressure Ulcer, Stage IV</condition>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Negative Pressure Wound Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</intervention_name>
    <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</intervention_name>
    <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Negative Pressure Wound Therapy</intervention_name>
    <description>Negative Pressure Wound Therapy</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form by subject or legally authorized&#xD;
             representative.&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study.&#xD;
&#xD;
          3. Male or female patients that are ≥ 21 years of age.&#xD;
&#xD;
          4. Body Mass Index (BMI) &lt;45.&#xD;
&#xD;
          5. At least one Stage 3 or 4 pressure injury (NPUAP Staging Guidelines) present at the&#xD;
             Screening and/or Treatment Visit located in any of the following regions:&#xD;
&#xD;
               1. Occipital&#xD;
&#xD;
               2. Back&#xD;
&#xD;
               3. Flank&#xD;
&#xD;
               4. Upper Extremity&#xD;
&#xD;
             i. Arm ii. Elbow iii. Wrist iv. Hand e. Sacral f. Hip g. Gluteal h. Ischial i. Lower&#xD;
             Extremity i. Leg ii. Knee iii. Ankle iv. Heel v. Foot&#xD;
&#xD;
          6. Surface dimensions of pressure injury must be between 9 to 64 cm2 inclusive (as&#xD;
             measured prior to treatment using a cm-scale ruler). The longest dimension must not&#xD;
             exceed 10 cm; depth must not exceed 5 cm.&#xD;
&#xD;
          7. Wound must be &gt;5 cm from the anus if colostomy not performed.&#xD;
&#xD;
          8. For lower extremity ulcers: Adequate arterial blood flow and perfusion near the site&#xD;
             of the injury (the foot is warm to the touch and has palpable pulses), per&#xD;
             Investigator judgement.&#xD;
&#xD;
          9. Confirmed pressure injury versus moisture-associated skin damage or friction injury.&#xD;
&#xD;
         10. Ability to maintain an intact occlusive dressing for 4-7 days with reinforcement&#xD;
             without contamination of urine or stool.&#xD;
&#xD;
         11. Confirmed fecal (Colostomy) and/or urine incontinence (Foley) maintenance/management,&#xD;
             if necessary.&#xD;
&#xD;
         12. Consent to off-loading (turns) from pressure sites a minimum of every 2 hours (if&#xD;
             possible).&#xD;
&#xD;
         13. Consent to sharp debridement of necrotic tissue in the wound bed unless the wound has&#xD;
             already undergone debridement within 5 days prior to the Treatment Visit.&#xD;
&#xD;
         14. For females of reproductive potential (defined as females ≤ 55 years of age): Negative&#xD;
             pregnancy test required prior to surgical debridement per hospital procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Surgical treatment of pressure injury 30 days prior to the Treatment Visit and/or&#xD;
             pressure injury in previously irradiated areas.&#xD;
&#xD;
          2. Inability to manage fecal and/or urine incontinence or patient refusal of its&#xD;
             maintenance/management (as determined medically necessary). Patient may be rescreened&#xD;
             and enrolled if urinary and/or fecal continence status or management change after&#xD;
             failure to comply with requirement.&#xD;
&#xD;
          3. Allergy or hypersensitivity to materials in porcine-based study products (per subject&#xD;
             report) or personal preference.&#xD;
&#xD;
          4. Currently treated for an active malignant disease.&#xD;
&#xD;
          5. Prior diagnosis of active malignant disease, and is less than 1 year disease-free.&#xD;
&#xD;
          6. History of malignancy within the wound.&#xD;
&#xD;
          7. Presence of any conditions that are contraindicated with NPWT.&#xD;
&#xD;
          8. Any condition associated with a wound healing abnormality (e.g.: connective tissue&#xD;
             disorder or immune disorder).&#xD;
&#xD;
          9. Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease).&#xD;
&#xD;
         10. Bleeding diathesis.&#xD;
&#xD;
         11. Patients with primary treatment ulcers from burns (from exposure to high heat) or&#xD;
             venous leg ulcers. A patient may have concomitant non-pressure ulcers present in&#xD;
             non-pressure ulcer treatment regions.&#xD;
&#xD;
         12. Received biological-based therapy in any pressure wound within 3 months of the&#xD;
             Treatment Visit.&#xD;
&#xD;
         13. Severe or significant hypoalbuminemia (albumin &lt;2.5 g/dL, and/or pre-albumin &lt;5&#xD;
             mg/dL), or hypoproteinemia (protein &lt;6 g/dL).&#xD;
&#xD;
         14. Moderate to severe anemia (Hgb &lt;7 g/dL).&#xD;
&#xD;
         15. Severely uncontrolled diabetes mellitus (defined as HA1C &gt;12%).&#xD;
&#xD;
         16. Subject report of concurrent participation in another clinical trial that involves an&#xD;
             investigational drug or device that would interfere with this study.&#xD;
&#xD;
         17. Subject report of previous participation in other interventional wound healing&#xD;
             clinical investigation within 60 days prior to the Screening Visit.&#xD;
&#xD;
         18. The subject has any physical or psychiatric condition that in the Investigator's&#xD;
             opinion would warrant exclusion from the study or prevent the subject from completing&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol Bowen-Wells, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Vincent's Medical Center Riverside</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Vincent's Medical Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>September 22, 2020</results_first_submitted>
  <results_first_submitted_qc>October 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 16, 2020</results_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pressure Ulcer</keyword>
  <keyword>ACell</keyword>
  <keyword>ACell MicroMatrix®</keyword>
  <keyword>ACell Cytal™</keyword>
  <keyword>Extracellular Matrix</keyword>
  <keyword>Urinary Bladder Matrix</keyword>
  <keyword>Wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
    <mesh_term>Crush Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03283787/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</title>
          <description>Treatment protocol per PI SOC discretion utilizing study devices.</description>
        </group>
        <group group_id="P2">
          <title>MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT</title>
          <description>Treatment protocol per PI SOC discretion utilizing study device plus NPWT.</description>
        </group>
        <group group_id="P3">
          <title>Negative Pressure Wound Therapy</title>
          <description>Treatment protocol per PI SOC discretion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>Negative Pressure Wound Therapy</description>
        </group>
        <group group_id="B4">
          <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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="35"/>
                  </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="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Complete Epithelialization</title>
        <description>Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</title>
            <description>Treatment protocol per PI discretion</description>
          </group>
          <group group_id="O2">
            <title>MicroMatrix® and Cytal™ Wound Matrix 2-Layer Plus NPWT</title>
            <description>Treatment protocol per PI discretion</description>
          </group>
          <group group_id="O3">
            <title>Negative Pressure Wound Therapyroup 3</title>
            <description>Treatment protocol per PI discretion</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Complete Epithelialization</title>
          <description>Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.</description>
          <units>No of wounds w/ complete epithelization</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete Wound Epithelization</title>
        <description>Time to complete wound epithelization between groups.</description>
        <time_frame>12 weeks</time_frame>
        <population>The secondary outcome analysis was confounded due to the heterogeneity of the data and amplified by the small samples size. The study data heterogeneity resulted from the clinically distinct wounds and subject risk profiles that limited interpretability and utility. This challenge was validated by an independent third party review.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Negative Pressure Wound Therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete Wound Epithelization</title>
          <description>Time to complete wound epithelization between groups.</description>
          <population>The secondary outcome analysis was confounded due to the heterogeneity of the data and amplified by the small samples size. The study data heterogeneity resulted from the clinically distinct wounds and subject risk profiles that limited interpretability and utility. This challenge was validated by an independent third party review.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Wound Epithelization</title>
        <description>Rate of wound epithelization between groups</description>
        <time_frame>12 weeks</time_frame>
        <population>The secondary outcome analysis was confounded due to the heterogeneity of the data and amplified by the small samples size. The study data heterogeneity resulted from the clinically distinct wounds and subject risk profiles that limited interpretability and utility. This challenge was validated by an independent third party review.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Negative Pressure Wound Therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Wound Epithelization</title>
          <description>Rate of wound epithelization between groups</description>
          <population>The secondary outcome analysis was confounded due to the heterogeneity of the data and amplified by the small samples size. The study data heterogeneity resulted from the clinically distinct wounds and subject risk profiles that limited interpretability and utility. This challenge was validated by an independent third party review.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT</description>
        </group>
        <group group_id="E3">
          <title>Group 3</title>
          <description>Negative Pressure Wound Therapy</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Blunt Trauma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Complications related to pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Disease and End stage renal disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hip/Femur Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="9" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia and AMS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Wound contamination, secondary to diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wound Recurrence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wound Vac Leaking</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lethargic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" events="20" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E3" events="25" subjects_affected="12" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Periwound Maceration</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" events="27" subjects_affected="15" subjects_at_risk="20"/>
                <counts group_id="E3" events="52" subjects_affected="19" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </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 NOT 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>
    <point_of_contact>
      <name_or_title>Allison Matthews</name_or_title>
      <organization>Integra LifeSciences</organization>
      <phone>443-766-3869</phone>
      <email>allison.matthews@integralife.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/NCT03283787
org study id: CA2016-001
nct id: NCT03283787
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 &
      4 pressure ulcers using ACell products.
A three arm, parallel-design, randomized study comparing 2 experimental arms to a single
      control arm. The primary comparison will be Group 1 (MicroMatrix® and ACell Cytal™ Wound
      Matrix 2-Layer vs. Group 3 (NPWT) to determine if Group 1 is superior to Group 3. NPWT is the
      standard of care (SOC) for patients with Stage 3 or 4 pressure ulcers and is the active
      control arm for the study.

      A secondary comparison will be conducted comparing Group 2 (MicroMatrix® and ACell Cytal™
      Wound Matrix 2-Layer plus NPWT) vs. Group 3 (NPWT) to determine if Group 2 is superior to
      Group 3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Complete Epithelialization
time frame: 12 weeks
description: Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
measure: Time to Complete Wound Epithelization
time frame: 12 weeks
description: Time to complete wound epithelization between groups.
measure: Rate of Wound Epithelization
time frame: 12 weeks
description: Rate of wound epithelization between groups
arm group label: Group 1
arm group type: Active Comparator
description: MicroMatrix® and Cytal™ Wound Matrix 2-Layer
arm group label: Group 2
arm group type: Active Comparator
description: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
arm group label: Group 3
arm group type: Active Comparator
description: Negative Pressure Wound Therapy
intervention type: Device
intervention name: MicroMatrix® and Cytal™ Wound Matrix 2-Layer
description: MicroMatrix® and Cytal™ Wound Matrix 2-Layer
arm group label: Group 1
intervention type: Device
intervention name: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
description: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
arm group label: Group 2
intervention type: Device
intervention name: Negative Pressure Wound Therapy
description: Negative Pressure Wound Therapy
arm group label: Group 3
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Carol Bowen-Wells, MD
role: Principal Investigator
affiliation: Saint Vincent's Medical Center Riverside
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer
mesh term: Crush Injuries
sharing ipd: No
ipd description: There is no plan to share individual participant data
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 