<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/NCT02985073</url>
  </required_header>
  <id_info>
    <org_study_id>189-16</org_study_id>
    <nct_id>NCT02985073</nct_id>
  </id_info>
  <brief_title>A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction</brief_title>
  <official_title>The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the outcome using a biological mesh (Veritas®) compared to a non&#xD;
      biological mesh (TIGR®) in immediate breast reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The scientific evidence using different types of mesh in breast reconstruction is low at&#xD;
      present with very few randomized controlled studies.&#xD;
&#xD;
      This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh&#xD;
      (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with&#xD;
      bilateral immediate breast reconstruction regarding implant loss rate,infections,total&#xD;
      complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.&#xD;
&#xD;
      The patients will be enrolled to the study and sign an informed consent. At the operating&#xD;
      theater the patient is randomized either to be reconstructed with Veritas® in one breast and&#xD;
      TIGR® in the other breast..&#xD;
&#xD;
      The patients will be followed up according to a specified schedule until one year&#xD;
      postoperatively as above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 2022</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total complication rate</measure>
    <time_frame>12 months</time_frame>
    <description>Total complication rate within one year from surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>Total infection rate within 30 days from surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total implant loss rate</measure>
    <time_frame>12 months</time_frame>
    <description>Total implant loss rate within one year from surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic outcome</measure>
    <time_frame>12 months</time_frame>
    <description>Aesthetic outcome at one year followup will be assessed by analysis of 3-dimensional pre- and post-op pictures in combination with a panel evaluating different aesthetical units of the breast</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HQOL</measure>
    <time_frame>12 months</time_frame>
    <description>Three validated questionaries will be used to assess HQOL: EQ-5D,HAD30 and BreastQ. The patient fills in these preoperatively and one year postop</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost evaluation</measure>
    <time_frame>12 months</time_frame>
    <description>Cost evaluation at one year followup will be evaluated in cooperation with hospital Economists,calculating the total post per patient with or without a mesh.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Veritas® mesh</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Veritas mesh in conjunction with immediate breast reconstruction on one side</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIGR® mesh</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Veritas®</intervention_name>
    <description>Biologic mesh</description>
    <arm_group_label>Veritas® mesh</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TIGR®</intervention_name>
    <description>Non biologic mesh</description>
    <arm_group_label>TIGR® mesh</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a confirmed breast cancer gene mutation or a calculated increased risk &gt;&#xD;
             20% of developing a breast cancer during her lifetime.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients that don't fulfill criteria above&#xD;
&#xD;
          -  Previous breast surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Kölby</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept . of plastic surgery</name>
      <address>
        <city>Goteborg</city>
        <state>Västra Götaland</state>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/33051871/</url>
    <description>Full text article</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/32515840/</url>
    <description>Full text article</description>
  </link>
  <results_reference>
    <citation>Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136. doi: 10.1080/2000656X.2019.1704766. Epub 2019 Dec 20.</citation>
    <PMID>31859575</PMID>
  </results_reference>
  <results_reference>
    <citation>Hansson E, Edvinsson AC, Hallberg H. Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921. Epub 2020 Jun 9.</citation>
    <PMID>32515840</PMID>
  </results_reference>
  <results_reference>
    <citation>Hansson E, Edvinsson AC, Elander A, Kolby L, Hallberg H. First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10.1002/jso.26227. Epub 2020 Oct 13.</citation>
    <PMID>33051871</PMID>
  </results_reference>
  <results_reference>
    <citation>Paganini A, Meyer S, Hallberg H, Hansson E. Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.</citation>
    <PMID>36154981</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02985073
org study id: 189-16
nct id: NCT02985073
lead sponsor: 
has dmc: No
This study compares the outcome using a biological mesh (Veritas®) compared to a non
      biological mesh (TIGR®) in immediate breast reconstruction.
The scientific evidence using different types of mesh in breast reconstruction is low at
      present with very few randomized controlled studies.

      This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh
      (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with
      bilateral immediate breast reconstruction regarding implant loss rate,infections,total
      complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.

      The patients will be enrolled to the study and sign an informed consent. At the operating
      theater the patient is randomized either to be reconstructed with Veritas® in one breast and
      TIGR® in the other breast..

      The patients will be followed up according to a specified schedule until one year
      postoperatively as above.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total complication rate
time frame: 12 months
description: Total complication rate within one year from surgery
measure: Total infection rate
time frame: 30 days
description: Total infection rate within 30 days from surgery
measure: Total implant loss rate
time frame: 12 months
description: Total implant loss rate within one year from surgery
measure: Aesthetic outcome
time frame: 12 months
description: Aesthetic outcome at one year followup will be assessed by analysis of 3-dimensional pre- and post-op pictures in combination with a panel evaluating different aesthetical units of the breast
measure: HQOL
time frame: 12 months
description: Three validated questionaries will be used to assess HQOL: EQ-5D,HAD30 and BreastQ. The patient fills in these preoperatively and one year postop
measure: Cost evaluation
time frame: 12 months
description: Cost evaluation at one year followup will be evaluated in cooperation with hospital Economists,calculating the total post per patient with or without a mesh.
arm group label: Veritas® mesh
arm group type: Experimental
description: Use of Veritas mesh in conjunction with immediate breast reconstruction on one side
arm group label: TIGR® mesh
arm group type: Experimental
description: Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side
intervention type: Device
intervention name: Veritas®
description: Biologic mesh
arm group label: Veritas® mesh
intervention type: Device
intervention name: TIGR®
description: Non biologic mesh
arm group label: TIGR® mesh
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Kölby
role: Principal Investigator
affiliation: Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden
facility: 
country: Sweden
url: https://pubmed.ncbi.nlm.nih.gov/33051871/
description: Full text article
url: https://pubmed.ncbi.nlm.nih.gov/32515840/
description: Full text article
citation: Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136. doi: 10.1080/2000656X.2019.1704766. Epub 2019 Dec 20.
PMID: 31859575
citation: Hansson E, Edvinsson AC, Hallberg H. Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921. Epub 2020 Jun 9.
PMID: 32515840
citation: Hansson E, Edvinsson AC, Elander A, Kolby L, Hallberg H. First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10.1002/jso.26227. Epub 2020 Oct 13.
PMID: 33051871
citation: Paganini A, Meyer S, Hallberg H, Hansson E. Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.
PMID: 36154981
responsible party type: Sponsor
sharing ipd: No