<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/NCT03027219</url>
  </required_header>
  <id_info>
    <org_study_id>S2016-2043-0003</org_study_id>
    <nct_id>NCT03027219</nct_id>
  </id_info>
  <brief_title>Blood Flow Change After Free Flap Surgery in Diabetic Patients</brief_title>
  <official_title>Prospective Observational Study of the Changes of Blood Flow of Arterial Anastomosis-site of Free Flap in Diabetic Patients Who Undergoing Free Flap Transfer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</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>
      We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in&#xD;
      diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: flow change of arterial anastomosis site during free flap surgery in diabetic&#xD;
      patients.&#xD;
&#xD;
      Background: No research was published about flow change of arterial anastomosis site of the&#xD;
      free flap during surgery.&#xD;
&#xD;
      Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated&#xD;
      before and after the administration of alprostadil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">November 29, 2018</completion_date>
  <primary_completion_date type="Actual">November 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Flow change</measure>
    <time_frame>before alprostadil administration, 30 mins after alprostadil administration</time_frame>
    <description>Peak velocity of anastomosis-site of free flap</description>
  </primary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Diabetes</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprostadil</intervention_name>
    <description>Vasodilator for anastomosis-site of free flap</description>
    <other_name>Eglandin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients who are undergoing free flap surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Plan to receive free flap transfer under general anesthesia&#xD;
&#xD;
          2. Age: &gt;=18 and &lt;80 years old&#xD;
&#xD;
          3. History of diabetes mellitus&#xD;
&#xD;
          4. Administration of alprostadil during surgery&#xD;
&#xD;
          5. Volunteer, who are provided written informed consent prior to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Refuse the participation of study&#xD;
&#xD;
          2. &gt;= American society of anesthesiologist physical status IV&#xD;
&#xD;
          3. Use of any vasopressor or inotropic for hemodynamic instability before participation&#xD;
             of study&#xD;
&#xD;
          4. Inappropriate subjects who are identified by researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-kug Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Young-Kug Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alprostadil</mesh_term>
  </intervention_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/NCT03027219
org study id: S2016-2043-0003
nct id: NCT03027219
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in
      diabetic patients.
Objective: flow change of arterial anastomosis site during free flap surgery in diabetic
      patients.

      Background: No research was published about flow change of arterial anastomosis site of the
      free flap during surgery.

      Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated
      before and after the administration of alprostadil.
observational model: Case-Only
time perspective: Prospective
measure: Flow change
time frame: before alprostadil administration, 30 mins after alprostadil administration
description: Peak velocity of anastomosis-site of free flap
intervention type: Drug
intervention name: Alprostadil
description: Vasodilator for anastomosis-site of free flap
other name: Eglandin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Young-kug Kim, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Young-Kug Kim
investigator title: Professor
mesh term: Alprostadil
sharing ipd: No