<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/NCT03028272</url>
  </required_header>
  <id_info>
    <org_study_id>2006074</org_study_id>
    <nct_id>NCT03028272</nct_id>
  </id_info>
  <brief_title>Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty</brief_title>
  <official_title>Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and&#xD;
      functional outcomes as fascia when used for tympanoplasties while offering benefits including&#xD;
      reduced operative time, better patient satisfaction, and fewer complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized controlled trial will be conducted. Eligible patients will be&#xD;
      identified, recruited and randomized to receive either repair using the standard fascia graft&#xD;
      or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation&#xD;
      followed by TM repair and subsequent regular office visits to assess functional outcomes,&#xD;
      complications, and satisfaction. Patients will be blinded to the substrate used for their&#xD;
      repair. As there are two different approaches for a tympanoplasty (through the ear canal or&#xD;
      incision behind the ear) based on the subject's ear anatomy and location of the perforation,&#xD;
      a sham surgery will not be necessary to disguise which graft is received. At follow up&#xD;
      visits, photos may be taken of patients' TMs and these photos will be evaluated for healing&#xD;
      by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up&#xD;
      appointment, subjects will be told which substrate they received and at the study's&#xD;
      conclusion subjects will notified about the study's findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of qualified participants&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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 (Participant)</masking>
    <masking_description>Participant will be blinded to the type of barrier received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparable or improved performance of Skye ActiveBarrier</measure>
    <time_frame>12-18 months</time_frame>
    <description>Comparable or improved performance will be assessed by combining data from 6 specific measurements: air and bone gap audiogram, word recognition score via audiogram, number of surgical/post-surgical complications, operating time and healing time.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Tympanic Membrane Perforation</condition>
  <arm_group>
    <arm_group_label>Fascia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Autologous donor substrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skye Barrier</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Amniotic membrane allograft</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skye Barrier</intervention_name>
    <description>Substrate derived from amniotic tissue that is FDA-approved for human implantation</description>
    <arm_group_label>Skye Barrier</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fascia</intervention_name>
    <description>Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia</description>
    <arm_group_label>Fascia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presence of a tympanic membrane perforation&#xD;
&#xD;
          2. Patient at PI's clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of cholesteatoma&#xD;
&#xD;
          2. Prior surgery on the same-sided TM or middle ear&#xD;
&#xD;
          3. Ossicular chain abnormalities&#xD;
&#xD;
          4. Congenital deformities involving the middle ear or eustachian tube&#xD;
&#xD;
          5. Refusal to undergo surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnaldo Rivera, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Arnaldo L. Rivera</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>tympanic membrane perforation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tympanic Membrane Perforation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators do not intend to share individual participant data to other researchers. Analyzed data will be published in peer-review journal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028272
org study id: 2006074
nct id: NCT03028272
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and
      functional outcomes as fascia when used for tympanoplasties while offering benefits including
      reduced operative time, better patient satisfaction, and fewer complications.
A prospective randomized controlled trial will be conducted. Eligible patients will be
      identified, recruited and randomized to receive either repair using the standard fascia graft
      or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation
      followed by TM repair and subsequent regular office visits to assess functional outcomes,
      complications, and satisfaction. Patients will be blinded to the substrate used for their
      repair. As there are two different approaches for a tympanoplasty (through the ear canal or
      incision behind the ear) based on the subject's ear anatomy and location of the perforation,
      a sham surgery will not be necessary to disguise which graft is received. At follow up
      visits, photos may be taken of patients' TMs and these photos will be evaluated for healing
      by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up
      appointment, subjects will be told which substrate they received and at the study's
      conclusion subjects will notified about the study's findings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participant will be blinded to the type of barrier received.
measure: Comparable or improved performance of Skye ActiveBarrier
time frame: 12-18 months
description: Comparable or improved performance will be assessed by combining data from 6 specific measurements: air and bone gap audiogram, word recognition score via audiogram, number of surgical/post-surgical complications, operating time and healing time.
arm group label: Fascia
arm group type: Active Comparator
description: Autologous donor substrate
arm group label: Skye Barrier
arm group type: Experimental
description: Amniotic membrane allograft
intervention type: Other
intervention name: Skye Barrier
description: Substrate derived from amniotic tissue that is FDA-approved for human implantation
arm group label: Skye Barrier
intervention type: Other
intervention name: Fascia
description: Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia
arm group label: Fascia
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaldo Rivera, M.D.
role: Principal Investigator
affiliation: University of Missouri-Columbia
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Arnaldo L. Rivera
investigator title: Associate Professor
mesh term: Tympanic Membrane Perforation
sharing ipd: No
ipd description: The investigators do not intend to share individual participant data to other researchers. Analyzed data will be published in peer-review journal.