<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/NCT04446936</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0366</org_study_id>
    <nct_id>NCT04446936</nct_id>
  </id_info>
  <brief_title>Comparing Different Surgical Techniques for Coverage of Pressure Ulcer</brief_title>
  <official_title>A Retrospective Study Comparing Failure and Complications Rates Between Propeller Flap and Random Flap for Pressure Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of&#xD;
      the Wound and Healing department, the first unit of this type to be created in Europe. The&#xD;
      investigators quickly became the national leader in the management of pressure ulcers,&#xD;
      especially in people with spinal cord injuries.&#xD;
&#xD;
      Our expertise has evolved over time as well as our surgical techniques for covering ulcers,&#xD;
      gradually over time the investigators have gone from &quot; random &quot; flaps to &quot; propeller &quot; flaps,&#xD;
      more reliable in terms of vascularization and more logical in terms of force distribution and&#xD;
      skin tension.&#xD;
&#xD;
      The investigators found subjectively that the rate of complications was lower for the helical&#xD;
      flaps. The investigators therefore seek to confirm this trend through a retrospective study&#xD;
      on patients operated on in the department between January 1, 2015 and December 31, 2019.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">December 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Failure rate</measure>
    <time_frame>1 day</time_frame>
    <description>Comparing failure rates between the two surgical techniques</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications rate</measure>
    <time_frame>1 day</time_frame>
    <description>Comparing complications rate between the two surgical techniques</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>Propeller flaps</arm_group_label>
    <description>Patients who undergone propeller flap surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Random flaps</arm_group_label>
    <description>Patients who undergone random flap surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flap covering for pressure ulcer</intervention_name>
    <description>Flap covering for pressure ulcer</description>
    <arm_group_label>Propeller flaps</arm_group_label>
    <arm_group_label>Random flaps</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sacral, trochanteric or ischiatic pressure ulcer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Major Patient&#xD;
&#xD;
          -  Patient with trochanteric, ischiatic or sacral pressure ulcer&#xD;
&#xD;
          -  Patient who undergone flap surgery for pressure ulcer between January 1st, 2015 and&#xD;
             December 31st, 2019&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Other loss of substance than pressure ulcer&#xD;
&#xD;
          -  Combined covering with a random flap and a propeller flap&#xD;
&#xD;
          -  Surgical revision of a flap without a new flap&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farid BEKARA, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcer</keyword>
  <keyword>Flap</keyword>
  <keyword>Random</keyword>
  <keyword>Propeller</keyword>
  <keyword>Paraplegic</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04446936
org study id: RECHMPL20_0366
nct id: NCT04446936
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of
      the Wound and Healing department, the first unit of this type to be created in Europe. The
      investigators quickly became the national leader in the management of pressure ulcers,
      especially in people with spinal cord injuries.

      Our expertise has evolved over time as well as our surgical techniques for covering ulcers,
      gradually over time the investigators have gone from " random " flaps to " propeller " flaps,
      more reliable in terms of vascularization and more logical in terms of force distribution and
      skin tension.

      The investigators found subjectively that the rate of complications was lower for the helical
      flaps. The investigators therefore seek to confirm this trend through a retrospective study
      on patients operated on in the department between January 1, 2015 and December 31, 2019.
observational model: Cohort
time perspective: Retrospective
measure: Failure rate
time frame: 1 day
description: Comparing failure rates between the two surgical techniques
measure: Complications rate
time frame: 1 day
description: Comparing complications rate between the two surgical techniques
arm group label: Propeller flaps
description: Patients who undergone propeller flap surgery
arm group label: Random flaps
description: Patients who undergone random flap surgery
intervention type: Procedure
intervention name: Flap covering for pressure ulcer
description: Flap covering for pressure ulcer
arm group label: Propeller flaps
arm group label: Random flaps
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Farid BEKARA, MD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer
sharing ipd: Undecided
ipd description: NC