<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/NCT03789266</url>
  </required_header>
  <id_info>
    <org_study_id>2016/382/HP</org_study_id>
    <nct_id>NCT03789266</nct_id>
  </id_info>
  <brief_title>Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique</brief_title>
  <acronym>TADDA</acronym>
  <official_title>Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      Comparison of ablation technique of drains&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2018</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>patient will not know which technique will be used for drain ablation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the pain felt by the patients at the time of the removal of the drain, using the pain visual analogue scale</measure>
    <time_frame>20 minutes</time_frame>
    <description>pain will be measured using a visual analogic scale from 0 (for no pain) to 10 (fo maximum pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of haematoma after ablation</measure>
    <time_frame>Day 2 post ablation</time_frame>
    <description>Presence or absence of haematoma will be visually checked</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <condition>Drain Insertion Site</condition>
  <arm_group>
    <arm_group_label>Drain ablation - Non Aspiration mode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drain ablation will be done in non Aspiration mode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drain ablation - Aspiration mode</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Drain ablation will be done in Aspiration mode</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>drain ablation</intervention_name>
    <description>drain ablation will be done in Aspiration mode or in non Aspiration mode</description>
    <arm_group_label>Drain ablation - Aspiration mode</arm_group_label>
    <arm_group_label>Drain ablation - Non Aspiration mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients admitted to the orthopedic surgery department for surgery for a total hip&#xD;
             arthroplasty&#xD;
&#xD;
          2. Signed inform consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Drain in non-aspirating mode at the time of medical ablation prescription&#xD;
&#xD;
          2. Administration of analgesic III in the 12 hours preceding the inclusion&#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>Mylène BONNAIRE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mylène BONNAIRE, Ms</last_name>
    <phone>+3323288</phone>
    <phone_ext>8265</phone_ext>
    <email>mylene.bonnaire@chu-rouen.Fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julien BLOT</last_name>
    <phone>+3323288</phone>
    <phone_ext>8265</phone_ext>
    <email>julien.blot@chu-rouen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mylène BONNAIRE</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</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/NCT03789266
org study id: 2016/382/HP
nct id: NCT03789266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of ablation technique of drains
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
masking description: patient will not know which technique will be used for drain ablation
measure: Evaluate the pain felt by the patients at the time of the removal of the drain, using the pain visual analogue scale
time frame: 20 minutes
description: pain will be measured using a visual analogic scale from 0 (for no pain) to 10 (fo maximum pain)
measure: Presence of haematoma after ablation
time frame: Day 2 post ablation
description: Presence or absence of haematoma will be visually checked
arm group label: Drain ablation - Non Aspiration mode
arm group type: Experimental
description: Drain ablation will be done in non Aspiration mode
arm group label: Drain ablation - Aspiration mode
arm group type: Other
description: Drain ablation will be done in Aspiration mode
intervention type: Procedure
intervention name: drain ablation
description: drain ablation will be done in Aspiration mode or in non Aspiration mode
arm group label: Drain ablation - Aspiration mode
arm group label: Drain ablation - Non Aspiration mode
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mylène BONNAIRE
role: Principal Investigator
affiliation: Rouen University Hospital
last name: Mylène BONNAIRE, Ms
phone: +3323288
phone ext: 8265
email: mylene.bonnaire@chu-rouen.Fr
last name: Julien BLOT
phone: +3323288
phone ext: 8265
email: julien.blot@chu-rouen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No