<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/NCT03282721</url>
  </required_header>
  <id_info>
    <org_study_id>S-K338</org_study_id>
    <nct_id>NCT03282721</nct_id>
  </id_info>
  <brief_title>Transverse Facial Cleft Repair Using Precise Location of Commissure</brief_title>
  <official_title>Transverse Facial Cleft (Macrostomia) Repair: Modification of a Traditional Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the effect of redesigned transverse facial cleft treatment and traditional&#xD;
      transverse facial cleft treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nine patients with transverse facial cleft were treated with redesigned repair using precise&#xD;
      location of commissure. The main outcome measurement included scar, symmetry of the&#xD;
      commissure. They were graded in five scores by five resident physicians who had never seen&#xD;
      the patients. The results were compared with healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">January 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Scar of the repaired commissures</measure>
    <time_frame>6 to 12 months after surgery</time_frame>
    <description>scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>symmetry of the commissures</measure>
    <time_frame>6 to 12 months after surgery</time_frame>
    <description>symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>scar of the repaired commissures</measure>
    <time_frame>immediately after surgery</time_frame>
    <description>scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symmetry of the commissures</measure>
    <time_frame>immediately after surgery</time_frame>
    <description>symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>scar of the repaired commissures</measure>
    <time_frame>1 to 6 months after surgery</time_frame>
    <description>scar of the repaired commissure was graded in five points. They were scored by five resident physicians who had never seen the patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symmetry of the commissures</measure>
    <time_frame>1 to 6 months after surgery</time_frame>
    <description>symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Transverse Facial Cleft</condition>
  <arm_group>
    <arm_group_label>redesigned</arm_group_label>
    <description>the commissure constructions of the cleft side were precised located, include the upper and lower inherent vermilion border, the interior commissure, the outline of commissure, the exterior commissure, the upper skin-mucosa junction and the lower skin-mucosa junction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>classical</arm_group_label>
    <description>follows the simple-symmetry rule, the commissure of the healthy side is measured, and then the affected side is located accordingly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>precise location of commissure</intervention_name>
    <arm_group_label>redesigned</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with transverse facial cleft who hadn't receive any treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of transverse facial cleft disease;&#xD;
&#xD;
          -  Must not received any lip surgeries before;&#xD;
&#xD;
          -  Such disease can be accompanied by external ear abnormalities, hypoplastic mandible,&#xD;
             cleft lip and palate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe general diseases;&#xD;
&#xD;
          -  Patients who had been treated with lip surgery;&#xD;
&#xD;
          -  Patients and/or his/her family didn't want to continue the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LIAN ZHOU, D.D.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lian Zhou</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Facies</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/NCT03282721
org study id: S-K338
nct id: NCT03282721
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effect of redesigned transverse facial cleft treatment and traditional
      transverse facial cleft treatment.
Nine patients with transverse facial cleft were treated with redesigned repair using precise
      location of commissure. The main outcome measurement included scar, symmetry of the
      commissure. They were graded in five scores by five resident physicians who had never seen
      the patients. The results were compared with healthy controls.
observational model: Case-Control
time perspective: Retrospective
measure: Scar of the repaired commissures
time frame: 6 to 12 months after surgery
description: scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.
measure: symmetry of the commissures
time frame: 6 to 12 months after surgery
description: symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.
measure: scar of the repaired commissures
time frame: immediately after surgery
description: scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.
measure: symmetry of the commissures
time frame: immediately after surgery
description: symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.
measure: scar of the repaired commissures
time frame: 1 to 6 months after surgery
description: scar of the repaired commissure was graded in five points. They were scored by five resident physicians who had never seen the patients.
measure: symmetry of the commissures
time frame: 1 to 6 months after surgery
description: symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.
arm group label: redesigned
description: the commissure constructions of the cleft side were precised located, include the upper and lower inherent vermilion border, the interior commissure, the outline of commissure, the exterior commissure, the upper skin-mucosa junction and the lower skin-mucosa junction.
arm group label: classical
description: follows the simple-symmetry rule, the commissure of the healthy side is measured, and then the affected side is located accordingly.
intervention type: Procedure
intervention name: precise location of commissure
arm group label: redesigned
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 5 Years
healthy volunteers: No
last name: LIAN ZHOU, D.D.S
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lian Zhou
investigator title: Prof.
mesh term: Facies
sharing ipd: No