<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/NCT03293186</url>
  </required_header>
  <id_info>
    <org_study_id>SNUHthyroid2</org_study_id>
    <nct_id>NCT03293186</nct_id>
  </id_info>
  <brief_title>Anti-adhesive Effect and Safety of &quot;Thermo-sensitive Adhesion Barrier (MEDICLORE)&quot;</brief_title>
  <official_title>Anti-adhesive Effect and Safety of &quot;Thermo-sensitive Adhesion Barrier (MEDICLORE)&quot; by Using Double-blind Test in Thyroid Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of most important complication of thyroid surgery is adhesion. There are many&#xD;
      anti-adhesive materials, but none of them showed significant outcomes. The investigators&#xD;
      planned double blind prospective study of &quot;Thermo-sensitive Adhesion Barrier (MEDICLORE)&quot; to&#xD;
      reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients&#xD;
      (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 27, 2020</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.</measure>
    <time_frame>Participants will be followed from the operation to postoperative 2weeks, 3months, 6months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Adhesion</condition>
  <condition>Thyroidectomy</condition>
  <arm_group>
    <arm_group_label>Use MEDICLORE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use mediclore at the end of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No antiadhesive product</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>use no antiadhesive product at the end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>MEDICLORE</intervention_name>
    <description>use MEDICLORE at the end of surgery as antiadhesive product</description>
    <arm_group_label>Use MEDICLORE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  planned to perform thyroidectomy due to thyroid nodule&#xD;
&#xD;
          -  no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer&#xD;
&#xD;
          -  normal preoperative vocal cord movement&#xD;
&#xD;
          -  normal preoperative laboratory study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy&#xD;
&#xD;
          -  history of keloid or hypertrophic scar&#xD;
&#xD;
          -  Graves disease or hashimoto thyroiditis patients&#xD;
&#xD;
          -  aspirin or anticoagulant medication within 7 days&#xD;
&#xD;
          -  radiation exposure to the head and neck&#xD;
&#xD;
          -  previous operation to the neck&#xD;
&#xD;
          -  history of allergic reaction to drugs&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Su-jin Kim</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03293186
org study id: SNUHthyroid2
nct id: NCT03293186
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
One of most important complication of thyroid surgery is adhesion. There are many
      anti-adhesive materials, but none of them showed significant outcomes. The investigators
      planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to
      reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients
      (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.
time frame: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months
arm group label: Use MEDICLORE
arm group type: Experimental
description: use mediclore at the end of surgery
arm group label: No antiadhesive product
arm group type: No Intervention
description: use no antiadhesive product at the end of surgery
intervention type: Combination Product
intervention name: MEDICLORE
description: use MEDICLORE at the end of surgery as antiadhesive product
arm group label: Use MEDICLORE
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Su-jin Kim
investigator title: Associate professor
mesh term: Tissue Adhesions
sharing ipd: No