xml: <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/NCT05994248</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00097688</org_study_id>
      <nct_id>NCT05994248</nct_id>
    </id_info>
    <brief_title>Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh</brief_title>
    <official_title>Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wake Forest University Health Sciences</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to see which of two types of mesh is better for fixing an umbilical&#xD;
        hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the&#xD;
        body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever.&#xD;
        The researchers will check if the hernia comes back, how it affects the patient's quality of&#xD;
        life, and if there are any problems after the surgery during a three-year period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus&#xD;
        non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality of life (QOL) and&#xD;
        postoperative complications in umbilical hernia repair. Patients will be randomized into one&#xD;
        of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients&#xD;
        will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort.&#xD;
        The hernia recurrence, quality of life and postoperative outcomes to determine if the two&#xD;
        meshes are non-inferior.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">June 2029</completion_date>
    <primary_completion_date type="Anticipated">June 2029</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Umbilical Hernia Recurrence</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of hernia recurrence 3-years postoperatively</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mesh Related Complication - Mesh infection</measure>
      <time_frame>1-year postoperatively</time_frame>
      <description>The rate of mesh infection within 1-year postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mesh Related Complication - Mesh excision</measure>
      <time_frame>1-year postoperatively</time_frame>
      <description>The rate of mesh excision within 1-year postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcome - 30-day readmission</measure>
      <time_frame>30-days postoperatively</time_frame>
      <description>The rate of 30-day readmission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcome - Seroma</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate seroma within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcome - Hematoma</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of hematoma within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcomes - Intra-abdominal abscess</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of intra-abdominal abscess within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcome - Wound cellulitis</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of wound cellulitis within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcome - Wound infection</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of wound infection within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcome - Superficial wound breakdown</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of superficial wound breakdown within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcomes - Mortality</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The rate of mortality within 3-years postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Outcomes - Length of stay</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>The length of stay (LOS) in the hospital postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life (QOL)</measure>
      <time_frame>3-years postoperatively</time_frame>
      <description>QOL within 3-years of surgery as measured by the Carolinas Comfort Scale (CCS), a validated hernia specific QOL questionnaire. The CCS has 23 questions across 3 domains (mesh sensation, pain, and movement) that are scored 0-5 and N/A. Higher scores indicate worse symptoms. A score of 2 or more in any category is considered &quot;symptomatic&quot;; a score of 0 or 1 is considered &quot;asymptomatic&quot;. Data will be reported as the frequency and percentage of &quot;symptomatic&quot; or &quot;asymptomatic&quot; for each of the 3 domains.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Umbilical Hernia</condition>
    <arm_group>
      <arm_group_label>Non-Absorbable Synthetic Mesh</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Absorbable Synthetic Mesh</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Enform Mesh</intervention_name>
      <description>Use of absorbable mesh in umbilical hernia repair</description>
      <arm_group_label>Absorbable Synthetic Mesh</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Marlex</intervention_name>
      <description>Use of non-absorbable mesh in umbilical hernia repair</description>
      <arm_group_label>Non-Absorbable Synthetic Mesh</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years and older&#xD;
  &#xD;
            -  Primary umbilical hernia repair (UHR) [as defined by European Hernia Society (EHS)&#xD;
               guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the&#xD;
               umbilicus]&#xD;
  &#xD;
            -  Undergoing elective laparoscopic or open repair&#xD;
  &#xD;
            -  Defect size of 1-4cm2&#xD;
  &#xD;
            -  Centers for Disease Control and Prevention (CDC) class 1 &amp; 2 wounds&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Todd Heniford, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Todd Heniford, MD</last_name>
      <phone>704-355-3168</phone>
      <email>Todd.Heniford@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Greg Scarola, MS</last_name>
      <phone>704-355-5766</phone>
      <email>Gregory.Scarola@AtriumHealth.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Carolinas Medical Center</name>
        <address>
          <city>Charlotte</city>
          <state>North Carolina</state>
          <zip>28204</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Todd Heniford, MD</last_name>
        <phone>704-355-3168</phone>
        <email>Todd.Heniford@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Greg Scarola, MS</last_name>
        <phone>704-355-5766</phone>
        <email>Gregory.Scarola@AtriumHealth.org</email>
      </contact_backup>
      <investigator>
        <last_name>Todd Heniford, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Randomized Controlled Trial (RCT)</keyword>
    <keyword>Absorbable Mesh</keyword>
    <keyword>Non-Absorbable Mesh</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia, Umbilical</mesh_term>
      <mesh_term>Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be made available to other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994248
  org study id: IRB00097688
  nct id: NCT05994248
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The goal of this study is to see which of two types of mesh is better for fixing an umbilical
        hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the
        body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever.
        The researchers will check if the hernia comes back, how it affects the patient's quality of
        life, and if there are any problems after the surgery during a three-year period.
  The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus
        non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality of life (QOL) and
        postoperative complications in umbilical hernia repair. Patients will be randomized into one
        of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients
        will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort.
        The hernia recurrence, quality of life and postoperative outcomes to determine if the two
        meshes are non-inferior.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Umbilical Hernia Recurrence
  time frame: 3-years postoperatively
  description: The rate of hernia recurrence 3-years postoperatively
  measure: Mesh Related Complication - Mesh infection
  time frame: 1-year postoperatively
  description: The rate of mesh infection within 1-year postoperatively
  measure: Mesh Related Complication - Mesh excision
  time frame: 1-year postoperatively
  description: The rate of mesh excision within 1-year postoperatively
  measure: Postoperative Outcome - 30-day readmission
  time frame: 30-days postoperatively
  description: The rate of 30-day readmission
  measure: Postoperative Outcome - Seroma
  time frame: 3-years postoperatively
  description: The rate seroma within 3-years postoperatively
  measure: Postoperative Outcome - Hematoma
  time frame: 3-years postoperatively
  description: The rate of hematoma within 3-years postoperatively
  measure: Postoperative Outcomes - Intra-abdominal abscess
  time frame: 3-years postoperatively
  description: The rate of intra-abdominal abscess within 3-years postoperatively
  measure: Postoperative Outcome - Wound cellulitis
  time frame: 3-years postoperatively
  description: The rate of wound cellulitis within 3-years postoperatively
  measure: Postoperative Outcome - Wound infection
  time frame: 3-years postoperatively
  description: The rate of wound infection within 3-years postoperatively
  measure: Postoperative Outcome - Superficial wound breakdown
  time frame: 3-years postoperatively
  description: The rate of superficial wound breakdown within 3-years postoperatively
  measure: Postoperative Outcomes - Mortality
  time frame: 3-years postoperatively
  description: The rate of mortality within 3-years postoperatively
  measure: Postoperative Outcomes - Length of stay
  time frame: 3-years postoperatively
  description: The length of stay (LOS) in the hospital postoperatively
  measure: Quality of Life (QOL)
  time frame: 3-years postoperatively
  description: QOL within 3-years of surgery as measured by the Carolinas Comfort Scale (CCS), a validated hernia specific QOL questionnaire. The CCS has 23 questions across 3 domains (mesh sensation, pain, and movement) that are scored 0-5 and N/A. Higher scores indicate worse symptoms. A score of 2 or more in any category is considered "symptomatic"; a score of 0 or 1 is considered "asymptomatic". Data will be reported as the frequency and percentage of "symptomatic" or "asymptomatic" for each of the 3 domains.
  arm group label: Non-Absorbable Synthetic Mesh
  arm group type: Experimental
  description: Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.
  arm group label: Absorbable Synthetic Mesh
  arm group type: Active Comparator
  description: Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.
  intervention type: Device
  intervention name: Enform Mesh
  description: Use of absorbable mesh in umbilical hernia repair
  arm group label: Absorbable Synthetic Mesh
  intervention type: Device
  intervention name: Marlex
  description: Use of non-absorbable mesh in umbilical hernia repair
  arm group label: Non-Absorbable Synthetic Mesh
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Todd Heniford, MD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Todd Heniford, MD
  phone: 704-355-3168
  email: Todd.Heniford@gmail.com
  last name: Greg Scarola, MS
  phone: 704-355-5766
  email: Gregory.Scarola@AtriumHealth.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hernia, Umbilical
  mesh term: Hernia
  sharing ipd: No
  ipd description: IPD will not be made available to other researchers.