<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/NCT04428463</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-13-20</org_study_id>
    <nct_id>NCT04428463</nct_id>
  </id_info>
  <brief_title>Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia</brief_title>
  <official_title>Fibrinogen- Based Collagen Fleece Graft Myringoplasty for Chronic Tympanic Membrane Perforations - a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</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>
      Tympanic membrane perforations are common medical problem that encounters a lot of patients&#xD;
      in all age groups.&#xD;
&#xD;
      The gold standard for treatment of perforations is tympanic membrane closure procedure&#xD;
      (tympanoplasty) which is done under general anesthesia.&#xD;
&#xD;
      This procedure could be problematic for many patients who are not suitable for general&#xD;
      anesthesia due to their medical status.&#xD;
&#xD;
      It's also time consuming for the patient and for the medical system, since it takes a lot of&#xD;
      time to reach the operation room and hospitalization for at least two days.&#xD;
&#xD;
      The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia&#xD;
      to close tympanic membrane perforations.&#xD;
&#xD;
      Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to&#xD;
      the tissue and form a waterproof membrane. In the setting of ENT clinic and under local&#xD;
      anesthesia, the investigators will start the procedure with debridement of the tympanic&#xD;
      perforation edges, then they will close the perforation using two pieces of Tachosil under&#xD;
      and above the perforation in the right form (active side to the active side).&#xD;
&#xD;
      If the results will be similar to tympanoplasty results, this method may be used for closure&#xD;
      of tympanic perforation and save time and money for the patient and for the health system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tympanoplasty is the gold standard treatment for tympanic membrane perforation.&#xD;
&#xD;
      It is done under general anesthesia in the following form:&#xD;
&#xD;
      Incision in the post auricular area, harvesting of fascia and cartilage from the concha of&#xD;
      the pinna .&#xD;
&#xD;
      In Trans ear canal approach starting with debridement of the edges of the tympanic membrane&#xD;
      perforation and closing the perforation using cartilage and fascia.&#xD;
&#xD;
      After being informed about the study and potential risks, all patients giving informed&#xD;
      consent will participate in the study.&#xD;
&#xD;
      This study will include two groups. The first group will be treated with the conventional way&#xD;
      as described above. The interventional group will be treated using Tachosil in the following&#xD;
      order:&#xD;
&#xD;
      Local anesthesia using Lidocadren (lidocaine and epinephrine) will be injected to the ear&#xD;
      canal using dental needle.&#xD;
&#xD;
      Debridement of the edges of the tympanic membrane perforation Placing the tachosil under and&#xD;
      above the perforation in the correct order. The patient could be discharged home immediately&#xD;
      after the procedure if no adverse effects are seen (dizziness, nausea or vomiting).&#xD;
&#xD;
      After one month, similar to the conventional treatment method, the patient will be invited to&#xD;
      the otology clinic, for hearing test and microscopic examuntaion of the tympanic membrane, to&#xD;
      see if the perforation is closed.&#xD;
&#xD;
      The study will compare the success rate in the two groups and if it will be similar that will&#xD;
      help publish this method and use it in patients who are not suitable to general anesthesia&#xD;
      and in hospitals were waiting time table for operation room is very long.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 30, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>two groups. In one we will use the conventional treatment strategy using tympanoplasty with fascia and cartilage.&#xD;
in the intervention group we will use tachosil in closing the perforations.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>closure of tympanic membrane perforation</measure>
    <time_frame>one month after the procedure</time_frame>
    <description>one month post operative the patient will be re-examined in the clinic to see if the perforation is closed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Tympanic Membrane Perforation</condition>
  <arm_group>
    <arm_group_label>tympanoplasty using fascia and cartilage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tympanoplasty under general anesthesia using fascia and cartilage witch is the gold standard for treating tympanic membrane perforations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tachosil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>repair of tympanic perforations under local anesthesia using Tachosil patch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tachosil</intervention_name>
    <description>tympanic membrane perforation repair using Tachosil patch under local anesthesia</description>
    <arm_group_label>Tachosil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fascia and cartilage</intervention_name>
    <description>tympanic membrane perforation repair using fascia and cartilage under general anesthesia</description>
    <arm_group_label>tympanoplasty using fascia and cartilage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic tympanic membrane perforation&#xD;
&#xD;
          -  dry ear at least 4 weeks before the procedure&#xD;
&#xD;
          -  no evidence of cholesteatoma&#xD;
&#xD;
          -  hearing test in the last 3 months&#xD;
&#xD;
          -  signing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  a known sensitivity for any ingredient&#xD;
&#xD;
          -  a perforation that is more than one third of the tympanic membrane area.&#xD;
&#xD;
          -  new onset perforation (less than 3 months)&#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_contact>
    <last_name>lev shlizerman, md</last_name>
    <phone>00972504433469</phone>
    <email>lev_sh@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mary ghrayeb haddad, md</last_name>
    <phone>00972509311771</phone>
    <email>mary_gh@clalit.org.il</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tympanic membrane perforation</keyword>
  <keyword>tachosil</keyword>
  <keyword>local anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tympanic Membrane Perforation</mesh_term>
  </condition_browse>
  <!-- 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/NCT04428463
org study id: EMC-13-20
nct id: NCT04428463
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Tympanic membrane perforations are common medical problem that encounters a lot of patients
      in all age groups.

      The gold standard for treatment of perforations is tympanic membrane closure procedure
      (tympanoplasty) which is done under general anesthesia.

      This procedure could be problematic for many patients who are not suitable for general
      anesthesia due to their medical status.

      It's also time consuming for the patient and for the medical system, since it takes a lot of
      time to reach the operation room and hospitalization for at least two days.

      The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia
      to close tympanic membrane perforations.

      Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to
      the tissue and form a waterproof membrane. In the setting of ENT clinic and under local
      anesthesia, the investigators will start the procedure with debridement of the tympanic
      perforation edges, then they will close the perforation using two pieces of Tachosil under
      and above the perforation in the right form (active side to the active side).

      If the results will be similar to tympanoplasty results, this method may be used for closure
      of tympanic perforation and save time and money for the patient and for the health system.
Tympanoplasty is the gold standard treatment for tympanic membrane perforation.

      It is done under general anesthesia in the following form:

      Incision in the post auricular area, harvesting of fascia and cartilage from the concha of
      the pinna .

      In Trans ear canal approach starting with debridement of the edges of the tympanic membrane
      perforation and closing the perforation using cartilage and fascia.

      After being informed about the study and potential risks, all patients giving informed
      consent will participate in the study.

      This study will include two groups. The first group will be treated with the conventional way
      as described above. The interventional group will be treated using Tachosil in the following
      order:

      Local anesthesia using Lidocadren (lidocaine and epinephrine) will be injected to the ear
      canal using dental needle.

      Debridement of the edges of the tympanic membrane perforation Placing the tachosil under and
      above the perforation in the correct order. The patient could be discharged home immediately
      after the procedure if no adverse effects are seen (dizziness, nausea or vomiting).

      After one month, similar to the conventional treatment method, the patient will be invited to
      the otology clinic, for hearing test and microscopic examuntaion of the tympanic membrane, to
      see if the perforation is closed.

      The study will compare the success rate in the two groups and if it will be similar that will
      help publish this method and use it in patients who are not suitable to general anesthesia
      and in hospitals were waiting time table for operation room is very long.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: two groups. In one we will use the conventional treatment strategy using tympanoplasty with fascia and cartilage.
in the intervention group we will use tachosil in closing the perforations.
primary purpose: Treatment
masking: None (Open Label)
measure: closure of tympanic membrane perforation
time frame: one month after the procedure
description: one month post operative the patient will be re-examined in the clinic to see if the perforation is closed.
arm group label: tympanoplasty using fascia and cartilage
arm group type: Active Comparator
description: tympanoplasty under general anesthesia using fascia and cartilage witch is the gold standard for treating tympanic membrane perforations.
arm group label: Tachosil
arm group type: Experimental
description: repair of tympanic perforations under local anesthesia using Tachosil patch.
intervention type: Procedure
intervention name: Tachosil
description: tympanic membrane perforation repair using Tachosil patch under local anesthesia
arm group label: Tachosil
intervention type: Procedure
intervention name: fascia and cartilage
description: tympanic membrane perforation repair using fascia and cartilage under general anesthesia
arm group label: tympanoplasty using fascia and cartilage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: lev shlizerman, md
phone: 00972504433469
email: lev_sh@clalit.org.il
last name: mary ghrayeb haddad, md
phone: 00972509311771
email: mary_gh@clalit.org.il
responsible party type: Sponsor
mesh term: Tympanic Membrane Perforation