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/NCT05967845</url>
    </required_header>
    <id_info>
      <org_study_id>MS.19.04.576</org_study_id>
      <nct_id>NCT05967845</nct_id>
    </id_info>
    <brief_title>Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty</brief_title>
    <official_title>Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</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>
        This study was performed to compare healing and hearing outcomes of two tympanoplasty&#xD;
        techniques, performed for patients with total or subtotal tympanic membrane perforations. The&#xD;
        first group underwent temporalis fascia tympanoplasty, augmented with platelet rich fibrin,&#xD;
        while the second group underwent cartilage tympanoplasty. preoperative data, operative&#xD;
        techniques, and postoperative outcomes were analyzed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two groups are included. In the platelet rich fibrin augmented tympanoplasty group, a piece&#xD;
        of temporalis fascia is harvested and used as a graft material. A layer of platelet rich&#xD;
        fibrin is added to improve healing process. In the cartilage tympanoplasty group, a piece of&#xD;
        cartilage is harvested from the patient concha and used for grafting. Both groups will be&#xD;
        compared in terms of healing and hearing. Healing is considered successful if an intact&#xD;
        tympanic membrane is achieved withing 12 weeks follow up period. Hearing outcomes are&#xD;
        analyzed by comparing the preoperative pure tone audiometry values with the postoperative&#xD;
        values.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2019</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</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>
    </study_design_info>
    <primary_outcome>
      <measure>Healing rate, or graft take rate.</measure>
      <time_frame>12 weeks</time_frame>
      <description>Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hearing outcomes</measure>
      <time_frame>12 weeks</time_frame>
      <description>Postoperative changes of hearing levels as assessed by pure tone audiometry.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">156</enrollment>
    <condition>Chronic Suppurative Otitis Media</condition>
    <arm_group>
      <arm_group_label>Platelet rich fibrin augmented tympanoplasty</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Platelet rich fibrin will be prepaired from the patient's own blood throud a centrifugation process and will be applied on the temproalis fascia graft to improve healing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cartilage tympanoplasty</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cartilage tympanoplasty</intervention_name>
      <description>cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.</description>
      <arm_group_label>cartilage tympanoplasty</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>platelet rich fibrin augmented tympanoplasty</intervention_name>
      <description>platelet rich fibrin augmented tympanoplasty entails performing the traditional tympanoplasty using the tempralis fascia as a grafting material. However, platelet rich fibrin clot is obtained from the patient's own blood, and applied to the graft to enhance healing process.</description>
      <arm_group_label>Platelet rich fibrin augmented tympanoplasty</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults patients older than 18 years.&#xD;
  &#xD;
            -  Chronic suppurative otitis media mucosal type with total or subtotal perforation.&#xD;
  &#xD;
            -  Inactive for 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recurrent perforation after previous tympanoplasty.&#xD;
  &#xD;
            -  Active inflammation of middle ear.&#xD;
  &#xD;
            -  Chronic suppurative otitis media epithelial type.&#xD;
  &#xD;
            -  Ossicular disruption or fixation diagnosed intraoperatively.&#xD;
  &#xD;
            -  Immunocompromised patients including uncontrolled diabetics, chronic liver and kidney&#xD;
               diseases.&#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>Hisham A Ebada, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mansoura University faculty of Medicine</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahlia</state>
          <zip>35511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <results_reference>
      <citation>Venkatesan D, Umamaheswaran P, Vellikkannu R, Kannan S, Sivaraman A, Ramamurthy S. A Comparative Study of Temporalis Fascia Graft and Full Thickness Tragal Island Cartilage Graft in Type 1 Tympanoplasty. Indian J Otolaryngol Head Neck Surg. 2022 Aug;74(Suppl 1):619-623. doi: 10.1007/s12070-021-02459-2. Epub 2021 Feb 19.</citation>
      <PMID>36032890</PMID>
    </results_reference>
    <results_reference>
      <citation>Jain A, Samdani S, Sharma MP, Meena V. Island cartilage vs temporalis fascia in type 1 tympanoplasty: A prospective study. Acta Otorrinolaringol Esp (Engl Ed). 2018 Nov-Dec;69(6):311-317. doi: 10.1016/j.otorri.2017.10.004. Epub 2018 Mar 22. English, Spanish.</citation>
      <PMID>29576202</PMID>
    </results_reference>
    <results_reference>
      <citation>Gokce Kutuk S, Ozdas T. Impact of platelet-rich fibrin therapy in tympanoplasty type 1 surgery on graft survival and frequency-specific hearing outcomes: a retrospective analysis in patients with tympanic membrane perforation due to chronic otitis media. J Laryngol Otol. 2019 Dec;133(12):1068-1073. doi: 10.1017/S0022215119002391. Epub 2019 Nov 18.</citation>
      <PMID>31735178</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University</investigator_affiliation>
      <investigator_full_name>Hisham Ebada</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Otitis Media, Suppurative</mesh_term>
      <mesh_term>Otitis Media</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05967845
  org study id: MS.19.04.576
  nct id: NCT05967845
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was performed to compare healing and hearing outcomes of two tympanoplasty
        techniques, performed for patients with total or subtotal tympanic membrane perforations. The
        first group underwent temporalis fascia tympanoplasty, augmented with platelet rich fibrin,
        while the second group underwent cartilage tympanoplasty. preoperative data, operative
        techniques, and postoperative outcomes were analyzed.
  Two groups are included. In the platelet rich fibrin augmented tympanoplasty group, a piece
        of temporalis fascia is harvested and used as a graft material. A layer of platelet rich
        fibrin is added to improve healing process. In the cartilage tympanoplasty group, a piece of
        cartilage is harvested from the patient concha and used for grafting. Both groups will be
        compared in terms of healing and hearing. Healing is considered successful if an intact
        tympanic membrane is achieved withing 12 weeks follow up period. Hearing outcomes are
        analyzed by comparing the preoperative pure tone audiometry values with the postoperative
        values.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Healing rate, or graft take rate.
  time frame: 12 weeks
  description: Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.
  measure: Hearing outcomes
  time frame: 12 weeks
  description: Postoperative changes of hearing levels as assessed by pure tone audiometry.
  arm group label: Platelet rich fibrin augmented tympanoplasty
  arm group type: Active Comparator
  description: Platelet rich fibrin will be prepaired from the patient's own blood throud a centrifugation process and will be applied on the temproalis fascia graft to improve healing.
  arm group label: cartilage tympanoplasty
  arm group type: Active Comparator
  description: A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty
  intervention type: Procedure
  intervention name: cartilage tympanoplasty
  description: cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.
  arm group label: cartilage tympanoplasty
  intervention type: Procedure
  intervention name: platelet rich fibrin augmented tympanoplasty
  description: platelet rich fibrin augmented tympanoplasty entails performing the traditional tympanoplasty using the tempralis fascia as a grafting material. However, platelet rich fibrin clot is obtained from the patient's own blood, and applied to the graft to enhance healing process.
  arm group label: Platelet rich fibrin augmented tympanoplasty
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hisham A Ebada, MD
  role: Principal Investigator
  affiliation: Mansoura University
  facility: 
  country: Egypt
  citation: Venkatesan D, Umamaheswaran P, Vellikkannu R, Kannan S, Sivaraman A, Ramamurthy S. A Comparative Study of Temporalis Fascia Graft and Full Thickness Tragal Island Cartilage Graft in Type 1 Tympanoplasty. Indian J Otolaryngol Head Neck Surg. 2022 Aug;74(Suppl 1):619-623. doi: 10.1007/s12070-021-02459-2. Epub 2021 Feb 19.
  PMID: 36032890
  citation: Jain A, Samdani S, Sharma MP, Meena V. Island cartilage vs temporalis fascia in type 1 tympanoplasty: A prospective study. Acta Otorrinolaringol Esp (Engl Ed). 2018 Nov-Dec;69(6):311-317. doi: 10.1016/j.otorri.2017.10.004. Epub 2018 Mar 22. English, Spanish.
  PMID: 29576202
  citation: Gokce Kutuk S, Ozdas T. Impact of platelet-rich fibrin therapy in tympanoplasty type 1 surgery on graft survival and frequency-specific hearing outcomes: a retrospective analysis in patients with tympanic membrane perforation due to chronic otitis media. J Laryngol Otol. 2019 Dec;133(12):1068-1073. doi: 10.1017/S0022215119002391. Epub 2019 Nov 18.
  PMID: 31735178
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University
  investigator full name: Hisham Ebada
  investigator title: Assistant Professor
  mesh term: Otitis Media, Suppurative
  mesh term: Otitis Media
  sharing ipd: No