<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/NCT04405687</url>
  </required_header>
  <id_info>
    <org_study_id>Follow Up</org_study_id>
    <nct_id>NCT04405687</nct_id>
  </id_info>
  <brief_title>Postoperative Follow up After Head and Face Reconstructive Surgeries</brief_title>
  <official_title>Post-reconstructive Surgeries of Severe Head and Face Deformities: An Observational Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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>
      In this observational follow-up study, patients with type III-IV head and face soft tissue&#xD;
      deformities/defects following reconstructive surgeries will be asked to fill out 3&#xD;
      questionnaires, either through phone calls or video calls, in order to evaluate the&#xD;
      post-operative outcomes such as morphological and functional recovery, quality of life and&#xD;
      patients' return to the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this follow up study is to evaluate the effectiveness and to analyze the&#xD;
      limitations of the existing management and treatment of severe burn injuries. Investigation&#xD;
      of the factors affecting the recovery and patients' return to the community in patients with&#xD;
      severe burn injury may lead to effective amendments of the existing management, and thus&#xD;
      aiding in the development of an integrated diagnosis and treatment guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">April 18, 2020</completion_date>
  <primary_completion_date type="Actual">April 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SF-36 total score</measure>
    <time_frame>12 minutes</time_frame>
    <description>8 aspects including actual physiological function, desirable physiological function, somatic pain, general health status, vitality, social function, emotional function, mental health; and 1 health indicator(reported health transition) Score ranges from 1-100 for each aspects, with higher score indicating a better quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aesthetic &amp; Functional total score (Patient edition)</measure>
    <time_frame>8 minutes</time_frame>
    <description>3 marks for each aspect; Score ranges from 0-18 for aesthetic status, and 0-21 for functional status, with higher score indicating a better outcome.&#xD;
For overall satisfaction of aesthetic and functional status preoperatively and postoperatively, score ranges from 0-10, with higher score indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EQ-5D-5L total score</measure>
    <time_frame>2 minutes</time_frame>
    <description>Assessment of the patients' mobility, self-care, usual activities, pain/discomfort, anxiety/depression.&#xD;
Score ranges from 0-100, with higher score indicating a better outcome.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Deformity of Face</condition>
  <arm_group>
    <arm_group_label>Severe head and face deformity</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Severe head and face deformity reconstructive surgery</intervention_name>
    <description>Three questionnaires, including the 36-Item Short Form Health Survey questionnaire (SF-36), Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects (A&amp;F) and Euroqol 5 dimensions 5 levels questionnaire (EQ-5D-5L), were conducted to evaluate their quality of life and satisfaction with facial aesthetic and functional status.</description>
    <arm_group_label>Severe head and face deformity</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This clinical study will include patients treated by Prof. Li Qingfeng 's professional team&#xD;
        who have undergone major head and face reconstructive surgeries before January 1, 2019.&#xD;
&#xD;
        It is estimated that about 85 patients will be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Preoperative facial soft tissue deformities/defects of type III and IV&#xD;
&#xD;
          2. Major reconstructive surgery of the head and neck (flap transfer with revision at&#xD;
             least once) performed before January 1, 2019.&#xD;
&#xD;
          3. Agreed and able to cooperate with the follow-ups, with signed informed consent form or&#xD;
             audio recorded informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with mental illness, reduced cognitive capacity, unable to consent and unable&#xD;
             to cooperate.&#xD;
&#xD;
          2. Minor patients without legal guardian.&#xD;
&#xD;
          3. Not willing to participate; informed consent form not signed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tao Zan, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>zantao</investigator_full_name>
    <investigator_title>Researcher of Plastic and Reconstructive Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04405687
org study id: Follow Up
nct id: NCT04405687
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this observational follow-up study, patients with type III-IV head and face soft tissue
      deformities/defects following reconstructive surgeries will be asked to fill out 3
      questionnaires, either through phone calls or video calls, in order to evaluate the
      post-operative outcomes such as morphological and functional recovery, quality of life and
      patients' return to the community.
The objective of this follow up study is to evaluate the effectiveness and to analyze the
      limitations of the existing management and treatment of severe burn injuries. Investigation
      of the factors affecting the recovery and patients' return to the community in patients with
      severe burn injury may lead to effective amendments of the existing management, and thus
      aiding in the development of an integrated diagnosis and treatment guidelines.
observational model: Other
time perspective: Retrospective
measure: SF-36 total score
time frame: 12 minutes
description: 8 aspects including actual physiological function, desirable physiological function, somatic pain, general health status, vitality, social function, emotional function, mental health; and 1 health indicator(reported health transition) Score ranges from 1-100 for each aspects, with higher score indicating a better quality of life.
measure: Aesthetic & Functional total score (Patient edition)
time frame: 8 minutes
description: 3 marks for each aspect; Score ranges from 0-18 for aesthetic status, and 0-21 for functional status, with higher score indicating a better outcome.
For overall satisfaction of aesthetic and functional status preoperatively and postoperatively, score ranges from 0-10, with higher score indicating a better outcome.
measure: EQ-5D-5L total score
time frame: 2 minutes
description: Assessment of the patients' mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Score ranges from 0-100, with higher score indicating a better outcome.
arm group label: Severe head and face deformity
intervention type: Procedure
intervention name: Severe head and face deformity reconstructive surgery
description: Three questionnaires, including the 36-Item Short Form Health Survey questionnaire (SF-36), Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects (A&F) and Euroqol 5 dimensions 5 levels questionnaire (EQ-5D-5L), were conducted to evaluate their quality of life and satisfaction with facial aesthetic and functional status.
arm group label: Severe head and face deformity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tao Zan, MD, PhD
role: Study Director
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: zantao
investigator title: Researcher of Plastic and Reconstructive Surgery
mesh term: Congenital Abnormalities
sharing ipd: Undecided