<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/NCT02967146</url>
  </required_header>
  <id_info>
    <org_study_id>2016-08-194-002</org_study_id>
    <nct_id>NCT02967146</nct_id>
  </id_info>
  <brief_title>Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer</brief_title>
  <official_title>Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <brief_summary>
    <textblock>
      Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and&#xD;
      chitosan(Mediclore®) after axillary dissection for breast cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Multicenter Double-blinded, Randomized Study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sum of ROM(range of motion)</measure>
    <time_frame>4weeks</time_frame>
    <description>to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sum of ROM(range of motion)</measure>
    <time_frame>24weeks</time_frame>
    <description>comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain assessment (numeric pain rating scale)</measure>
    <time_frame>4weeks, 24weeks</time_frame>
    <description>to compare the differences of the pain related with motions of upper limbs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scoring DASH(Disablities of the arm, shoulder and hand)</measure>
    <time_frame>4weeks, 24weeks</time_frame>
    <description>to compare the differences of the DASH score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Breastcancer</condition>
  <condition>Surgery: Axillary Dissection</condition>
  <arm_group>
    <arm_group_label>Mediclore</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Not done</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment for surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>adhesive barrier</intervention_name>
    <description>After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.</description>
    <arm_group_label>Mediclore</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patients needed axillary dissection in breast cancer&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Patients without clinically significant lab&#xD;
&#xD;
          -  the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having enrolled another clinical trials within 1 month&#xD;
&#xD;
          -  Immunosuppression or autoimmune disease&#xD;
&#xD;
          -  Anticoagulant, general steroids within a week from surgery&#xD;
&#xD;
          -  Incompatible medications&#xD;
&#xD;
          -  Serious diseases (heart failure, renal failure, liver failure, uncontrolled&#xD;
             hypertension, diabetes mellitus, coagulation deficiencies)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Seok won Kim, MD</last_name>
    <phone>+82-2-3410-2375</phone>
    <email>seokwon1.kim@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul City</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung Min Park, MD</last_name>
      <phone>+82-2-3410-3660</phone>
      <email>gs_sm.park@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Seok Won Kim</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02967146
org study id: 2016-08-194-002
nct id: NCT02967146
lead sponsor: 
Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and
      chitosan(Mediclore®) after axillary dissection for breast cancer
A Multicenter Double-blinded, Randomized Study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: sum of ROM(range of motion)
time frame: 4weeks
description: to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
measure: sum of ROM(range of motion)
time frame: 24weeks
description: comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
measure: pain assessment (numeric pain rating scale)
time frame: 4weeks, 24weeks
description: to compare the differences of the pain related with motions of upper limbs
measure: Scoring DASH(Disablities of the arm, shoulder and hand)
time frame: 4weeks, 24weeks
description: to compare the differences of the DASH score
arm group label: Mediclore
arm group type: Experimental
arm group label: Not done
arm group type: No Intervention
description: Standard treatment for surgery
intervention type: Device
intervention name: adhesive barrier
description: After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.
arm group label: Mediclore
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Seok won Kim, MD
phone: +82-2-3410-2375
email: seokwon1.kim@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Seok Won Kim
investigator title: MD
mesh term: Breast Neoplasms