<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/NCT02263261</url>
  </required_header>
  <id_info>
    <org_study_id>MTF 13-03</org_study_id>
    <nct_id>NCT02263261</nct_id>
  </id_info>
  <brief_title>Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction</brief_title>
  <official_title>Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Musculoskeletal Transplant Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Musculoskeletal Transplant Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Use of a HADM and implant in post-mastectomy breast reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-site pilot study in which outcomes associated with the use of&#xD;
      Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in&#xD;
      post-mastectomy breast reconstruction will be obtained. The data collected will include&#xD;
      reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to&#xD;
      ascertain advantages and disadvantages of using this particular HADM in post-mastectomy&#xD;
      breast reconstruction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Types and incidence of complications</measure>
    <time_frame>6 months post reconstruction</time_frame>
    <description>Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aesthetic Outcomes</measure>
    <time_frame>6 months post reconstruction</time_frame>
    <description>Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes</measure>
    <time_frame>6 months post reconstruction</time_frame>
    <description>Use of the Breast Q survey instrument</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Mastectomy</condition>
  <condition>Breast Reconstruction</condition>
  <arm_group>
    <arm_group_label>Flex HD Pliable Perforated HADM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flex HD Pliable Perforated HADM</intervention_name>
    <description>Human Acellular Dermal Matrix</description>
    <arm_group_label>Flex HD Pliable Perforated HADM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo a single or two-stage, tissue-assisted, implant breast&#xD;
             reconstruction&#xD;
&#xD;
          -  Mastectomy may be unilateral or bilateral, prophylactic or therapeutic&#xD;
&#xD;
          -  Skin incision may be skin sparing, or nipple-areolar sparing&#xD;
&#xD;
          -  Have signed written, informed consent&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing autologous breast reconstruction&#xD;
&#xD;
          -  Patients undergoing breast reconstruction following complications of breast&#xD;
             augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)&#xD;
&#xD;
          -  Patients undergoing reconstruction after previously failed attempts at reconstruction&#xD;
&#xD;
          -  Patients undergoing autologous breast reconstruction in conjunction with a tissue&#xD;
             expander (such as a latissimus dorsi flap, DIEP flap)&#xD;
&#xD;
          -  There will be no exclusions based on race or ethnicity&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Previous Radiation Treatment. Note: Post-operative radiation treatment does not&#xD;
             exclude subjects from study continuation once enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Liu Plastic surgery</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liu Plastic Surgery</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dermal matrix</keyword>
  <!-- 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/NCT02263261
org study id: MTF 13-03
nct id: NCT02263261
lead sponsor: 
has dmc: No
Use of a HADM and implant in post-mastectomy breast reconstruction.
This is a prospective, single-site pilot study in which outcomes associated with the use of
      Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in
      post-mastectomy breast reconstruction will be obtained. The data collected will include
      reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to
      ascertain advantages and disadvantages of using this particular HADM in post-mastectomy
      breast reconstruction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Types and incidence of complications
time frame: 6 months post reconstruction
description: Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
measure: Aesthetic Outcomes
time frame: 6 months post reconstruction
description: Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise
measure: Patient-Reported Outcomes
time frame: 6 months post reconstruction
description: Use of the Breast Q survey instrument
arm group label: Flex HD Pliable Perforated HADM
arm group type: Other
description: Single Arm
intervention type: Other
intervention name: Flex HD Pliable Perforated HADM
description: Human Acellular Dermal Matrix
arm group label: Flex HD Pliable Perforated HADM
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor