<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/NCT02246608</url>
  </required_header>
  <id_info>
    <org_study_id>KHN-RSWound-P14-N01</org_study_id>
    <nct_id>NCT02246608</nct_id>
  </id_info>
  <brief_title>Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy</brief_title>
  <official_title>Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kettering Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kettering Health Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure&#xD;
      Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the&#xD;
      wound prior to activating the NPWT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be&#xD;
      randomized to receive either:&#xD;
&#xD;
        1. Oasis® matrix, applied to the wound, along with standard of care including NPWT OR&#xD;
&#xD;
        2. Standard foam, applied to the wound prior to activation of NPWT, which is standard care.&#xD;
&#xD;
      Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation&#xD;
      canister will be collected for specimen analysis.&#xD;
&#xD;
      The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix&#xD;
      with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth&#xD;
      factors and interleukins in fluid evacuated from the wound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Closure Rate of Non-healing Wounds</measure>
    <time_frame>12 weeks</time_frame>
    <description>Wound dimensions will be measured weekly and monitored for changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth Factors</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fluid collected from the wound will be examined for the presence of growth factors and interleukins.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Open Wound Abdominal Wall</condition>
  <condition>Wound Non Healing</condition>
  <arm_group>
    <arm_group_label>Routine NPWT Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NPWT Standard of Care plus Oasis wound product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NPWT Standard of Care plus Oasis wound product</intervention_name>
    <description>Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.</description>
    <arm_group_label>NPWT Standard of Care plus Oasis wound product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Routine NPWT Standard of Care</intervention_name>
    <description>Specialized material, often foam, designed to protect the wound and promote healing during NPWT.</description>
    <arm_group_label>Routine NPWT Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of&#xD;
             infection.&#xD;
&#xD;
          -  HbA1C &lt; 8 (if patient is diabetic)&#xD;
&#xD;
          -  Adequate nutrition including albumin above 2.0 and prealbumin above 15.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wounds that cannot have a NPWT device properly applied due to location (too close to&#xD;
             anus), diarrhea, periwound skin issues.&#xD;
&#xD;
          -  Patients with Infected wounds.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Simman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kettering Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <results_first_submitted>February 6, 2018</results_first_submitted>
  <results_first_submitted_qc>July 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2018</results_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>July 30, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02246608/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NPWT Standard of Care</title>
          <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.&#xD;
Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.</description>
        </group>
        <group group_id="P2">
          <title>NPWT Standard of Care Plus Oasis Wound Product</title>
          <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.&#xD;
Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NPWT Standard of Care</title>
          <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.&#xD;
Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.</description>
        </group>
        <group group_id="B2">
          <title>NPWT Standard of Care Plus Oasis Wound Product</title>
          <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.&#xD;
Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.</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="10"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="21"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </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_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_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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </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_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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Closure Rate of Non-healing Wounds</title>
        <description>Wound dimensions will be measured weekly and monitored for changes</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NPWT Standard of Care</title>
            <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.&#xD;
Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.</description>
          </group>
          <group group_id="O2">
            <title>NPWT Standard of Care Plus Oasis Wound Product</title>
            <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.&#xD;
Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.</description>
          </group>
        </group_list>
        <measure>
          <title>Closure Rate of Non-healing Wounds</title>
          <description>Wound dimensions will be measured weekly and monitored for changes</description>
          <units>percentage of healing</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.79" spread="38.72"/>
                    <measurement group_id="O2" value="89.98" spread="9.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Growth Factors</title>
        <description>Fluid collected from the wound will be examined for the presence of growth factors and interleukins.</description>
        <time_frame>12 weeks</time_frame>
        <population>Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>NPWT Standard of Care</title>
            <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.&#xD;
Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.</description>
          </group>
          <group group_id="O2">
            <title>NPWT Standard of Care Plus Oasis Wound Product</title>
            <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.&#xD;
Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.</description>
          </group>
        </group_list>
        <measure>
          <title>Growth Factors</title>
          <description>Fluid collected from the wound will be examined for the presence of growth factors and interleukins.</description>
          <population>Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements.</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from time of consent to completion of 12 week study visit.</time_frame>
      <desc>The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected.&#xD;
Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.</desc>
      <group_list>
        <group group_id="E1">
          <title>NPWT Standard of Care</title>
          <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.&#xD;
Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.</description>
        </group>
        <group group_id="E2">
          <title>NPWT Standard of Care Plus Oasis Wound Product</title>
          <description>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied.&#xD;
Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <description>infection from PEG tube malfunction</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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>Manager, Research Operation and Regulatory Compliance</name_or_title>
      <organization>Kettering Health Network</organization>
      <phone>937-395-8367</phone>
      <email>innovationcenter@ketteringhealth.org</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/NCT02246608
org study id: KHN-RSWound-P14-N01
nct id: NCT02246608
lead sponsor: 
has dmc: No
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure
      Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the
      wound prior to activating the NPWT.
In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be
      randomized to receive either:

        1. Oasis® matrix, applied to the wound, along with standard of care including NPWT OR

        2. Standard foam, applied to the wound prior to activation of NPWT, which is standard care.

      Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation
      canister will be collected for specimen analysis.

      The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix
      with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth
      factors and interleukins in fluid evacuated from the wound.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Closure Rate of Non-healing Wounds
time frame: 12 weeks
description: Wound dimensions will be measured weekly and monitored for changes
measure: Growth Factors
time frame: 12 weeks
description: Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
arm group label: Routine NPWT Standard of Care
arm group type: Active Comparator
description: Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.
arm group label: NPWT Standard of Care plus Oasis wound product
arm group type: Experimental
description: Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing.
intervention type: Device
intervention name: NPWT Standard of Care plus Oasis wound product
description: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.
arm group label: NPWT Standard of Care plus Oasis wound product
intervention type: Device
intervention name: Routine NPWT Standard of Care
description: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
arm group label: Routine NPWT Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Richard Simman, MD
role: Principal Investigator
affiliation: Kettering Health Network
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 