xml: <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/NCT06037616</url>
    </required_header>
    <id_info>
      <org_study_id>2023 LAUTRETTE E-SUTURE</org_study_id>
      <nct_id>NCT06037616</nct_id>
    </id_info>
    <brief_title>Teaching Simple Skin Sutures to Medical Students</brief_title>
    <acronym>E-SUTURE</acronym>
    <official_title>Comparison of Methods for Teaching Simple Skin Sutures to Medical Students: a Randomized Blinded Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Clermont-Ferrand</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Clermont-Ferrand</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>
        Learning the simple skin suture is part of the surgical basics required for all medical&#xD;
        students, including future general practitioners.&#xD;
  &#xD;
        However, there is no data in the educational literature to help choose the best learning&#xD;
        technique.&#xD;
  &#xD;
        Several teams have offered video learning showing the correct technique. Level n+1 peer&#xD;
        learning was also proposed, without and with supervision by an expert.&#xD;
  &#xD;
        The investigators propose to carry out a prospective study comparing the quality of sutures&#xD;
        and knowledge according to the chosen learning method.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Send to medical student a teaching package two weeks before simulation session to practice&#xD;
        skin suture. There are 4 teaching packages related to 4 interventional groups The skin suture&#xD;
        performed by medical students are recorded on video. 1 video per medical student.&#xD;
  &#xD;
        The skin sutures recorded in these video are rated by two blinded expert with evaluation&#xD;
        grid.&#xD;
  &#xD;
        After the simulation session, the students complete knowledge, self-confidence, satisfaction&#xD;
        and mental load questionnaires&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>quality of skin suture</measure>
      <time_frame>15 days after simulation session</time_frame>
      <description>Quality of suture on anonymized video recording during the assessment day, rated by the blinded expert using an evaluation grid evaluation grid is made up of 14 items from the litterature the minimum value is: 0 (worse outcome) and maximum value is: 15 points (better outcome)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>knowledge of student</measure>
      <time_frame>15 days after simulation session</time_frame>
      <description>8 multiple choice questions (5 items per MCQ); the minimum value is: 0 (worse outcome) and maximum value is: 8 points (better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>self-confidence of student</measure>
      <time_frame>15 days after simulation session</time_frame>
      <description>self evaluation with a Likert scale (5points); point 0 corresponds to &quot;no confidence&quot;; point 5 corresponds to &quot;total confidence&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mental load of student</measure>
      <time_frame>15 days after simulation session</time_frame>
      <description>self evaluation with a Likert scale (9points); point 0 corresponds to &quot;very low&quot;; point 9 corresponds to &quot;very high&quot;</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Medical Students</condition>
    <arm_group>
      <arm_group_label>gr A: powerpoint and tutor</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>teaching with powerpoint and tutor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>gr B: powerpoint and tutor and video skill</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>teaching with powerpoint and tutor and video showing skill to perform a skin suture</description>
    </arm_group>
    <arm_group>
      <arm_group_label>gr C: powerpoint and tutor and video error</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>teaching with powerpoint and tutor and video showing errors</description>
    </arm_group>
    <arm_group>
      <arm_group_label>gr D: powerpoint and tutor and video skill and error</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>teaching with powerpoint and tutor and video showing skill to perform a skin suture and errors</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>powerpoint and tutor</intervention_name>
      <description>Powerpoint on indication of skin suture and tutor for the skill to perform skin suture</description>
      <arm_group_label>gr A: powerpoint and tutor</arm_group_label>
      <arm_group_label>gr B: powerpoint and tutor and video skill</arm_group_label>
      <arm_group_label>gr C: powerpoint and tutor and video error</arm_group_label>
      <arm_group_label>gr D: powerpoint and tutor and video skill and error</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>video skill</intervention_name>
      <description>Video showing skill to perform a skin suture</description>
      <arm_group_label>gr B: powerpoint and tutor and video skill</arm_group_label>
      <arm_group_label>gr D: powerpoint and tutor and video skill and error</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>video errors</intervention_name>
      <description>Video showing errors of skin suture</description>
      <arm_group_label>gr C: powerpoint and tutor and video error</arm_group_label>
      <arm_group_label>gr D: powerpoint and tutor and video skill and error</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Medical student of the faculty of Clermont-Ferrand&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexandre Lautrette</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU de Clermont-Ferrand</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nicolas D'Ostrevy</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU de Clermont-Ferrand</affiliation>
    </overall_official>
    <overall_official>
      <last_name>geraud galvaing</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Jean Perrin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lise Laclautre</last_name>
      <phone>04 73 75 11 95</phone>
      <email>drci@chu-clermontferrand.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU de Clermont-Ferrand</name>
        <address>
          <city>Clermont-Ferrand</city>
          <zip>63000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexandre Lautrette</last_name>
        <email>alautrette@chu-clermontferrand.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037616
  org study id: 2023 LAUTRETTE E-SUTURE
  nct id: NCT06037616
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Learning the simple skin suture is part of the surgical basics required for all medical
        students, including future general practitioners.
  
        However, there is no data in the educational literature to help choose the best learning
        technique.
  
        Several teams have offered video learning showing the correct technique. Level n+1 peer
        learning was also proposed, without and with supervision by an expert.
  
        The investigators propose to carry out a prospective study comparing the quality of sutures
        and knowledge according to the chosen learning method.
  Send to medical student a teaching package two weeks before simulation session to practice
        skin suture. There are 4 teaching packages related to 4 interventional groups The skin suture
        performed by medical students are recorded on video. 1 video per medical student.
  
        The skin sutures recorded in these video are rated by two blinded expert with evaluation
        grid.
  
        After the simulation session, the students complete knowledge, self-confidence, satisfaction
        and mental load questionnaires
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  measure: quality of skin suture
  time frame: 15 days after simulation session
  description: Quality of suture on anonymized video recording during the assessment day, rated by the blinded expert using an evaluation grid evaluation grid is made up of 14 items from the litterature the minimum value is: 0 (worse outcome) and maximum value is: 15 points (better outcome)
  measure: knowledge of student
  time frame: 15 days after simulation session
  description: 8 multiple choice questions (5 items per MCQ); the minimum value is: 0 (worse outcome) and maximum value is: 8 points (better outcome)
  measure: self-confidence of student
  time frame: 15 days after simulation session
  description: self evaluation with a Likert scale (5points); point 0 corresponds to "no confidence"; point 5 corresponds to "total confidence"
  measure: mental load of student
  time frame: 15 days after simulation session
  description: self evaluation with a Likert scale (9points); point 0 corresponds to "very low"; point 9 corresponds to "very high"
  arm group label: gr A: powerpoint and tutor
  arm group type: Active Comparator
  description: teaching with powerpoint and tutor
  arm group label: gr B: powerpoint and tutor and video skill
  arm group type: Active Comparator
  description: teaching with powerpoint and tutor and video showing skill to perform a skin suture
  arm group label: gr C: powerpoint and tutor and video error
  arm group type: Active Comparator
  description: teaching with powerpoint and tutor and video showing errors
  arm group label: gr D: powerpoint and tutor and video skill and error
  arm group type: Active Comparator
  description: teaching with powerpoint and tutor and video showing skill to perform a skin suture and errors
  intervention type: Other
  intervention name: powerpoint and tutor
  description: Powerpoint on indication of skin suture and tutor for the skill to perform skin suture
  arm group label: gr A: powerpoint and tutor
  arm group label: gr B: powerpoint and tutor and video skill
  arm group label: gr C: powerpoint and tutor and video error
  arm group label: gr D: powerpoint and tutor and video skill and error
  intervention type: Other
  intervention name: video skill
  description: Video showing skill to perform a skin suture
  arm group label: gr B: powerpoint and tutor and video skill
  arm group label: gr D: powerpoint and tutor and video skill and error
  intervention type: Other
  intervention name: video errors
  description: Video showing errors of skin suture
  arm group label: gr C: powerpoint and tutor and video error
  arm group label: gr D: powerpoint and tutor and video skill and error
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Alexandre Lautrette
  role: Principal Investigator
  affiliation: CHU de Clermont-Ferrand
  last name: Nicolas D'Ostrevy
  role: Principal Investigator
  affiliation: CHU de Clermont-Ferrand
  last name: geraud galvaing
  role: Principal Investigator
  affiliation: Centre Jean Perrin
  last name: Lise Laclautre
  phone: 04 73 75 11 95
  email: drci@chu-clermontferrand.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor