<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/NCT03823963</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-418</org_study_id>
    <secondary_id>2018-A00694-51</secondary_id>
    <nct_id>NCT03823963</nct_id>
  </id_info>
  <brief_title>Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery</brief_title>
  <acronym>MEPICARD</acronym>
  <official_title>A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Molnlycke Health Care AB</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomised controlled trial of patients admitted for a scheduled cardiac&#xD;
      surgery at the Clermont-Ferrand hospital.&#xD;
&#xD;
      Patients meeting the study inclusion criteria will be allocated to either the control group&#xD;
      that will receive pressure ulcer prevention standard care or the intervention group that will&#xD;
      receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied&#xD;
      to their sacrum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this research is to evaluate the impact of Mepilex Border® dressing&#xD;
      applied in addition to standard pressure ulcer prevention protocol, in a French hospital&#xD;
      setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation&#xD;
      including block operation and ICU.&#xD;
&#xD;
      Hypothesis: Patients treated with Mepilex® Border dressings will have a lower incidence rate&#xD;
      of sacral pressure ulcer development than patients receiving standard care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure ulcer incidence</measure>
    <time_frame>0-20 days</time_frame>
    <description>Incidence of sacral pressure ulcers acquired during patients' hospital stay</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">478</enrollment>
  <condition>Pressure Ulcers</condition>
  <condition>Prevention</condition>
  <condition>Skin Ulcer</condition>
  <condition>Ulcer</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>pressure ulcer prevention standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care + Mepilex® Border</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pressure ulcer prevention standard care + Mepilex® Border applied on sacrum</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Mepilex® Border dressing</intervention_name>
    <description>Soft silicone self-adherent dressing (5-layers)</description>
    <arm_group_label>standard care + Mepilex® Border</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>The control group will receive pressure ulcer prevention standard care</description>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_label>standard care + Mepilex® Border</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject over 18 years of age,&#xD;
&#xD;
          -  Subject programmed to benefit from cardiac surgery with sternotomy,&#xD;
&#xD;
          -  Subject capable and willing to comply with the protocol and willing to give his&#xD;
             written consent,&#xD;
&#xD;
          -  Subject affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with a skin lesion in the sacral area upon admission,&#xD;
&#xD;
          -  Subject admitted for emergency cardiovascular surgery (unscheduled subject),&#xD;
&#xD;
          -  Subject admitted for heart transplant surgery,&#xD;
&#xD;
          -  Subject participating in another clinical study or in a period of exclusion from a&#xD;
             study previous,&#xD;
&#xD;
          -  Subject with a linguistic or psychological disability to sign informed consent,&#xD;
&#xD;
          -  Subject refusing to give written consent,&#xD;
&#xD;
          -  Subject deprived of liberty by administrative or judicial decision, under guardianship&#xD;
             or curatorship.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franck HENTZ</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>04 73 75 49 63</phone>
    <email>drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lise LACLAUTRE</last_name>
      <phone>04 73 75 49 63</phone>
      <email>drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Franck HENTZ</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Skin Ulcer</mesh_term>
    <mesh_term>Ulcer</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/NCT03823963
org study id: CHU-418
secondary id: 2018-A00694-51
nct id: NCT03823963
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study is a randomised controlled trial of patients admitted for a scheduled cardiac
      surgery at the Clermont-Ferrand hospital.

      Patients meeting the study inclusion criteria will be allocated to either the control group
      that will receive pressure ulcer prevention standard care or the intervention group that will
      receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied
      to their sacrum.
The main objective of this research is to evaluate the impact of Mepilex Border® dressing
      applied in addition to standard pressure ulcer prevention protocol, in a French hospital
      setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation
      including block operation and ICU.

      Hypothesis: Patients treated with Mepilex® Border dressings will have a lower incidence rate
      of sacral pressure ulcer development than patients receiving standard care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pressure ulcer incidence
time frame: 0-20 days
description: Incidence of sacral pressure ulcers acquired during patients' hospital stay
arm group label: Standard care
arm group type: Other
description: pressure ulcer prevention standard care
arm group label: standard care + Mepilex® Border
arm group type: Experimental
description: pressure ulcer prevention standard care + Mepilex® Border applied on sacrum
intervention type: Combination Product
intervention name: Mepilex® Border dressing
description: Soft silicone self-adherent dressing (5-layers)
arm group label: standard care + Mepilex® Border
intervention type: Other
intervention name: Standard care
description: The control group will receive pressure ulcer prevention standard care
arm group label: Standard care
arm group label: standard care + Mepilex® Border
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franck HENTZ
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: 04 73 75 49 63
email: drci@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Skin Ulcer
mesh term: Ulcer