<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/NCT03817242</url>
  </required_header>
  <id_info>
    <org_study_id>LadyRH</org_study_id>
    <nct_id>NCT03817242</nct_id>
  </id_info>
  <brief_title>Half-thickness Tragal Cartilage Graft vs Temporalis Fascia Graft Tympanoplasty Type I</brief_title>
  <acronym>PTA</acronym>
  <official_title>Comparison of Half-thickness Tragal Cartilage Graft to Temporalis Fascia Graft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lady Reading Hospital, Pakistan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lady Reading Hospital, Pakistan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rationale of this study is to find out the surgical outcome and success rates of tragal&#xD;
      cartilage and temporalis fascia, subsequently to develop guide line in light of the results&#xD;
      of this study for our department as our institute is going to follow one patient in one bed&#xD;
      policy in future. The purpose of this study is to compare the graft success rate of cartilage&#xD;
      versus temporalis fascia in tympanoplasty type I in our institute, as no such study has been&#xD;
      conducted in our province before.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tympanic membrane is forming lateral wall of the middle ear cleft which separates middle ear&#xD;
      from the external auditory canal. It is made of three layers except in the upper part (Pars&#xD;
      Flaccida). The outer layer of TM (Tympanic Membrane) is made of epithelium; middle layer is&#xD;
      fibrous tissue, while inner layer is mucosal lining. The thickness of TM measures 0.1 mm,&#xD;
      having diameter of 7-10 mm, weighing approximately 14 mg. The function of TM is to assist in&#xD;
      hearing and protection of middle ear from infection. Perforation in tympanic membrane is the&#xD;
      loss in continuity of TM layers. The causes of TM perforation may be trauma like blast,&#xD;
      accident and firearm or infection of the middle ear like acute or chronic suppurative otitis&#xD;
      media. It can also be iatrogenic as in case of placement of grommet for glue ear. The purpose&#xD;
      of Tympanoplasty is to reconstruct TM perforation and restores sound conducting mechanism. In&#xD;
      1955, Zoellner and Wullstein used different types of graft materials for tympanoplasty. Later&#xD;
      Heermann introduced cartilage palisade graft labeled as Simmering Technique. Similarly&#xD;
      Goodhill also introduced first cartilage perichondrium composite graft material. Different&#xD;
      graft materials can be used to close the TM defect. Some of these materials are temporalis&#xD;
      fascia, tragal cartilage, perichondrium and fat. Temporalis fascia and tragal perichondrium&#xD;
      had more anatomic proximity, compliance and translucency. The mode of action of these&#xD;
      biological graft materials is that it provides support for the membrane remnant to&#xD;
      proliferate and heal the defect. The temporalis fascia is thin, translucent and available in&#xD;
      sufficient amount; but due to its close resemblance with tympanomeatal flap in color it may&#xD;
      be displaced unintentionally during handling. However the reported success rate of temporalis&#xD;
      fascia graft in literature varies from 93 to 97%.&#xD;
&#xD;
      On the other hand cartilage is middle ear friendly and survives for comparatively longer time&#xD;
      due to the fact that its nourishment is based on diffusion process. Due to rigid nature of&#xD;
      cartilage it prevents medialization of the graft to promontory in case of severe eustachian&#xD;
      tube dysfunction. Cartilage graft is used in cases of chronically malfunction eustachian&#xD;
      tube, adhesive otitis media, recurrent perforation and large TM perforation. But its demerits&#xD;
      are its thick nature which hinders sound conduction and it is limited availability. The&#xD;
      success rate of the cartilage graft tympanoplasty varies in the literature from 43 - 100%.&#xD;
&#xD;
      Chronic suppurative otitis media is an endemic health problem in our society. The reasons&#xD;
      could be probably low literacy level, communities situated far flung from health facilities,&#xD;
      lack of specialist service to the public in outreach area and inappropriate treatment of the&#xD;
      middle ear infections. Sufficient number of patient suffering from inactive mucosal chronic&#xD;
      otitis media with decreased hearing are presenting to otolaryngology unit. Tympanoplasty is&#xD;
      the surgery of choice for chronic otitis media inactive mucosal type.&#xD;
&#xD;
      Hypothesis is that cartilage graft tympanoplasty is more successful than temporalis fascia&#xD;
      tympanoplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>Tympanoplasty I is performed in these patients in Group 1 tragal cartilage graft is used while in group 2 temporalis fascia graft is used</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Graft take up</measure>
    <time_frame>06 months of follow up</time_frame>
    <description>the graft take rate is determined in both the groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective change in hearing level</measure>
    <time_frame>03 months of follow up</time_frame>
    <description>Change in hearing level is objectively assessed by performing pure tone audiometry and that is recorded in decibels on audiogram</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hearing satisfaction: whispering test</measure>
    <time_frame>05 months of follow up</time_frame>
    <description>Individual hearing satisfaction will be assessed subjectively, by whispering test in which whispering sound is offered to the individual and improvement in hearing level is recorded on proforma</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hearing Loss,Conductive</condition>
  <arm_group>
    <arm_group_label>tympanoplasty with tragal cartilage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tympanoplasty was performed using tragal cartilage graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tympanoplasty with temporalis fascia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tympanoplasty was performed using temporalis fascia graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tympanoplasty using tragal cartilage graft</intervention_name>
    <description>tympanoplasty type I is performed using tragal cartilage in arm 1</description>
    <arm_group_label>tympanoplasty with tragal cartilage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tympanoplasty using temporalis fascia graft</intervention_name>
    <description>tympanoplasty type I is performed using temporalis fascia in arm 2</description>
    <arm_group_label>tympanoplasty with temporalis fascia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients of both genders in the age range 16 - 60 years.&#xD;
&#xD;
          -  Inactive mucosal COM remained dry for at least one month.&#xD;
&#xD;
          -  Conductive hearing loss with minimum air-bone gap (ABG) of 10 Decibel (dB).&#xD;
&#xD;
          -  Middle ear is free of disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Attic and / or posterior retraction pocket with cholesteatoma.&#xD;
&#xD;
          -  Ossicular chain dysfunction and associated otogenic complication.&#xD;
&#xD;
          -  Active mucosal COM.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zahid Nazar</last_name>
    <role>Study Director</role>
    <affiliation>Lady Reading Hospital, Peshawar, Pakistan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fazali Wahid</name>
      <address>
        <city>Peshawar</city>
        <state>Khyberpakhtunkhwa</state>
        <zip>25000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lady Reading Hospital, Pakistan</investigator_affiliation>
    <investigator_full_name>Fazal Wahid</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cartilage</keyword>
  <keyword>Hearing loss</keyword>
  <keyword>Tympanoplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Conductive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This data can be share with other researcher through indexed journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>UPTO 5 YEARS</ipd_time_frame>
    <ipd_access_criteria>in 6 months and for 5 years</ipd_access_criteria>
  </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/NCT03817242
org study id: LadyRH
nct id: NCT03817242
lead sponsor: 
has dmc: No
The rationale of this study is to find out the surgical outcome and success rates of tragal
      cartilage and temporalis fascia, subsequently to develop guide line in light of the results
      of this study for our department as our institute is going to follow one patient in one bed
      policy in future. The purpose of this study is to compare the graft success rate of cartilage
      versus temporalis fascia in tympanoplasty type I in our institute, as no such study has been
      conducted in our province before.
Tympanic membrane is forming lateral wall of the middle ear cleft which separates middle ear
      from the external auditory canal. It is made of three layers except in the upper part (Pars
      Flaccida). The outer layer of TM (Tympanic Membrane) is made of epithelium; middle layer is
      fibrous tissue, while inner layer is mucosal lining. The thickness of TM measures 0.1 mm,
      having diameter of 7-10 mm, weighing approximately 14 mg. The function of TM is to assist in
      hearing and protection of middle ear from infection. Perforation in tympanic membrane is the
      loss in continuity of TM layers. The causes of TM perforation may be trauma like blast,
      accident and firearm or infection of the middle ear like acute or chronic suppurative otitis
      media. It can also be iatrogenic as in case of placement of grommet for glue ear. The purpose
      of Tympanoplasty is to reconstruct TM perforation and restores sound conducting mechanism. In
      1955, Zoellner and Wullstein used different types of graft materials for tympanoplasty. Later
      Heermann introduced cartilage palisade graft labeled as Simmering Technique. Similarly
      Goodhill also introduced first cartilage perichondrium composite graft material. Different
      graft materials can be used to close the TM defect. Some of these materials are temporalis
      fascia, tragal cartilage, perichondrium and fat. Temporalis fascia and tragal perichondrium
      had more anatomic proximity, compliance and translucency. The mode of action of these
      biological graft materials is that it provides support for the membrane remnant to
      proliferate and heal the defect. The temporalis fascia is thin, translucent and available in
      sufficient amount; but due to its close resemblance with tympanomeatal flap in color it may
      be displaced unintentionally during handling. However the reported success rate of temporalis
      fascia graft in literature varies from 93 to 97%.

      On the other hand cartilage is middle ear friendly and survives for comparatively longer time
      due to the fact that its nourishment is based on diffusion process. Due to rigid nature of
      cartilage it prevents medialization of the graft to promontory in case of severe eustachian
      tube dysfunction. Cartilage graft is used in cases of chronically malfunction eustachian
      tube, adhesive otitis media, recurrent perforation and large TM perforation. But its demerits
      are its thick nature which hinders sound conduction and it is limited availability. The
      success rate of the cartilage graft tympanoplasty varies in the literature from 43 - 100%.

      Chronic suppurative otitis media is an endemic health problem in our society. The reasons
      could be probably low literacy level, communities situated far flung from health facilities,
      lack of specialist service to the public in outreach area and inappropriate treatment of the
      middle ear infections. Sufficient number of patient suffering from inactive mucosal chronic
      otitis media with decreased hearing are presenting to otolaryngology unit. Tympanoplasty is
      the surgery of choice for chronic otitis media inactive mucosal type.

      Hypothesis is that cartilage graft tympanoplasty is more successful than temporalis fascia
      tympanoplasty.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Tympanoplasty I is performed in these patients in Group 1 tragal cartilage graft is used while in group 2 temporalis fascia graft is used
primary purpose: Treatment
masking: None (Open Label)
measure: Graft take up
time frame: 06 months of follow up
description: the graft take rate is determined in both the groups
measure: Objective change in hearing level
time frame: 03 months of follow up
description: Change in hearing level is objectively assessed by performing pure tone audiometry and that is recorded in decibels on audiogram
measure: Hearing satisfaction: whispering test
time frame: 05 months of follow up
description: Individual hearing satisfaction will be assessed subjectively, by whispering test in which whispering sound is offered to the individual and improvement in hearing level is recorded on proforma
arm group label: tympanoplasty with tragal cartilage
arm group type: Active Comparator
description: Tympanoplasty was performed using tragal cartilage graft
arm group label: tympanoplasty with temporalis fascia
arm group type: Active Comparator
description: Tympanoplasty was performed using temporalis fascia graft
intervention type: Procedure
intervention name: Tympanoplasty using tragal cartilage graft
description: tympanoplasty type I is performed using tragal cartilage in arm 1
arm group label: tympanoplasty with tragal cartilage
intervention type: Procedure
intervention name: Tympanoplasty using temporalis fascia graft
description: tympanoplasty type I is performed using temporalis fascia in arm 2
arm group label: tympanoplasty with temporalis fascia
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zahid Nazar
role: Study Director
affiliation: Lady Reading Hospital, Peshawar, Pakistan
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Lady Reading Hospital, Pakistan
investigator full name: Fazal Wahid
investigator title: Assistant Professor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Conductive
sharing ipd: Yes
ipd description: This data can be share with other researcher through indexed journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: UPTO 5 YEARS
ipd access criteria: in 6 months and for 5 years