<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/NCT03243344</url>
  </required_header>
  <id_info>
    <org_study_id>SHC/2009/001/P</org_study_id>
    <nct_id>NCT03243344</nct_id>
  </id_info>
  <brief_title>Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery</brief_title>
  <acronym>PRHEPOCE</acronym>
  <official_title>Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficiency and the cost of three medical devices and the abstention&#xD;
      of the use of specific product for the post-operative haemostasis in endonasal surgery .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the&#xD;
      post-operative bleeding of which one of the indications is in endonasal surgery.&#xD;
&#xD;
      Floseal® is a haemostatic frost(gel) containing of the thrombin.&#xD;
&#xD;
      Algosteril® is a lint tent of arginate of calcium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Per-operative hemostasis</measure>
    <time_frame>Hours 0</time_frame>
    <description>Time needs to observe hemostasis after the device set up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemostasis in the 6 first hours</measure>
    <time_frame>Hours 6</time_frame>
    <description>Number of compresses used from Hours 0 to Hours 6.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemostasis at the 24th hour</measure>
    <time_frame>Hours 24</time_frame>
    <description>Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type)&#xD;
Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spontaneous hemorrhagic events</measure>
    <time_frame>from Hours 0 to Day 45</time_frame>
    <description>number of spontaneous hemorrhagic events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preoperative assessment</measure>
    <time_frame>Before the endonasal surgery</time_frame>
    <description>Preoperative scanner assessment with Lund ans Mackay score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative assessment</measure>
    <time_frame>Hours 0</time_frame>
    <description>Laboratory tests of hemostasis (platelets, fibrinogen...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device evaluation by the surgeon</measure>
    <time_frame>Hours 0</time_frame>
    <description>time needs to set up the device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device evaluation by the surgeon</measure>
    <time_frame>Hours 0</time_frame>
    <description>subjective assessment of the implementation ease</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">571</enrollment>
  <condition>Otorhinolaryngologic Diseases</condition>
  <arm_group>
    <arm_group_label>Surgiflo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Floseal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Algosteril</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abstention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Not using device for the post-operative haemostasis in endonasal surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgiflo</intervention_name>
    <description>using device during the endonasal surgery.</description>
    <arm_group_label>Surgiflo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Floseal</intervention_name>
    <description>using device during the endonasal surgery.</description>
    <arm_group_label>Floseal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Algosteril</intervention_name>
    <description>using device during the endonasal surgery.</description>
    <arm_group_label>Algosteril</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  endonasal surgery schedule&#xD;
&#xD;
          -  Surgical indications:&#xD;
&#xD;
        hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body,&#xD;
        polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Woman&#xD;
&#xD;
          -  Disorder of the haemostasis known or disrupted preoperative biological balance&#xD;
             assessment&#xD;
&#xD;
          -  Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K,&#xD;
             AINS)&#xD;
&#xD;
          -  Unchecked HTA by the treatment and/or preoperative &gt; mmHg 160/90&#xD;
&#xD;
          -  Surgical Act including a septoplasty&#xD;
&#xD;
          -  malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system&#xD;
&#xD;
          -  Dacryocystorhinostomy&#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>Laurent TAVERNIER, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Besançon</affiliation>
  </overall_official>
  <verification_date>March 2010</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</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>Otorhinolaryngologic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgiflo</mesh_term>
  </intervention_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/NCT03243344
org study id: SHC/2009/001/P
nct id: NCT03243344
lead sponsor: 
has dmc: Yes
This study evaluates the efficiency and the cost of three medical devices and the abstention
      of the use of specific product for the post-operative haemostasis in endonasal surgery .
Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the
      post-operative bleeding of which one of the indications is in endonasal surgery.

      Floseal® is a haemostatic frost(gel) containing of the thrombin.

      Algosteril® is a lint tent of arginate of calcium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Per-operative hemostasis
time frame: Hours 0
description: Time needs to observe hemostasis after the device set up
measure: Hemostasis in the 6 first hours
time frame: Hours 6
description: Number of compresses used from Hours 0 to Hours 6.
measure: Hemostasis at the 24th hour
time frame: Hours 24
description: Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type)
Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.
measure: Spontaneous hemorrhagic events
time frame: from Hours 0 to Day 45
description: number of spontaneous hemorrhagic events.
measure: Preoperative assessment
time frame: Before the endonasal surgery
description: Preoperative scanner assessment with Lund ans Mackay score
measure: Preoperative assessment
time frame: Hours 0
description: Laboratory tests of hemostasis (platelets, fibrinogen...)
measure: Device evaluation by the surgeon
time frame: Hours 0
description: time needs to set up the device
measure: Device evaluation by the surgeon
time frame: Hours 0
description: subjective assessment of the implementation ease
arm group label: Surgiflo
arm group type: Experimental
description: Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.
arm group label: Floseal
arm group type: Experimental
description: Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery
arm group label: Algosteril
arm group type: Experimental
description: Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery
arm group label: Abstention
arm group type: No Intervention
description: Not using device for the post-operative haemostasis in endonasal surgery
intervention type: Device
intervention name: Surgiflo
description: using device during the endonasal surgery.
arm group label: Surgiflo
intervention type: Device
intervention name: Floseal
description: using device during the endonasal surgery.
arm group label: Floseal
intervention type: Device
intervention name: Algosteril
description: using device during the endonasal surgery.
arm group label: Algosteril
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent TAVERNIER, PH
role: Principal Investigator
affiliation: CHU Besançon
responsible party type: Sponsor
mesh term: Otorhinolaryngologic Diseases
mesh term: Surgiflo