<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/NCT03004274</url>
  </required_header>
  <id_info>
    <org_study_id>StJo-Paris-01</org_study_id>
    <nct_id>NCT03004274</nct_id>
  </id_info>
  <brief_title>Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients</brief_title>
  <official_title>Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Joseph University, Beirut, Lebanon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St Joseph University, Beirut, Lebanon</source>
  <brief_summary>
    <textblock>
      The goal of this study is to assess whether running deep wound stiches will be superior to&#xD;
      deep interrupted stiches in body contouring surgeries in massive weight loss patients. This&#xD;
      is a split-wound study, thereby providing an internal control within each wound. Each side of&#xD;
      the wound will be randomized to receive one of the two suturing techniques. Patients and&#xD;
      raters will be blinded to the suture technique used in both wound-halfs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scar cosmesis</measure>
    <time_frame>15 days</time_frame>
    <description>The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar cosmesis</measure>
    <time_frame>1.5 months</time_frame>
    <description>The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar cosmesis</measure>
    <time_frame>3 months</time_frame>
    <description>The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar cosmesis</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of Scar Width</measure>
    <time_frame>3 months</time_frame>
    <description>The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Scar Width</measure>
    <time_frame>6 months</time_frame>
    <description>The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>15 days</time_frame>
    <description>Noting the presence or absence of dehiscence, infection or spitting sutures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1.5 months</time_frame>
    <description>Noting the presence or absence of dehiscence, infection or spitting sutures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>3 months</time_frame>
    <description>Noting the presence or absence of dehiscence, infection or spitting sutures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>6 months</time_frame>
    <description>Noting the presence or absence of dehiscence, infection or spitting sutures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent suturing the wound</measure>
    <time_frame>up to 24h</time_frame>
    <description>The time spent suturing each half of the scar will be recorded in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of suture thread needed</measure>
    <time_frame>up to 24h</time_frame>
    <description>The number of threads used to suture each half of the scar will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Running sutures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Deep layers will be closed using running sutures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interrupted sutures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep layers will be closed using interrupted sutures</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Running sutures</intervention_name>
    <arm_group_label>Running sutures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interrupted sutures</intervention_name>
    <arm_group_label>Interrupted sutures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and over&#xD;
&#xD;
          -  Brachioplasty, Tighplasty, abdominoplasty, circumferential dermolipectomy in a massive&#xD;
             weight loss patient&#xD;
&#xD;
          -  The subjects are in good health&#xD;
&#xD;
          -  The subject has the willingness and the ability to understand and provide informed&#xD;
             consent for the use of their tissue and communicate with the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Subjects who are unable to understand the protocol or to give informed consent&#xD;
&#xD;
          -  Subjects with mental illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saint Josph Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>samer Jabbour, MD</last_name>
      <phone>+3384570068</phone>
    </contact>
    <investigator>
      <last_name>samer Jabbour, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Taliah Schmitt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondation Hôpital Saint-Joseph</investigator_affiliation>
    <investigator_full_name>samer jabbour</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</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/NCT03004274
org study id: StJo-Paris-01
nct id: NCT03004274
lead sponsor: 
collaborator: 
The goal of this study is to assess whether running deep wound stiches will be superior to
      deep interrupted stiches in body contouring surgeries in massive weight loss patients. This
      is a split-wound study, thereby providing an internal control within each wound. Each side of
      the wound will be randomized to receive one of the two suturing techniques. Patients and
      raters will be blinded to the suture technique used in both wound-halfs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Scar cosmesis
time frame: 15 days
description: The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
measure: Scar cosmesis
time frame: 1.5 months
description: The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
measure: Scar cosmesis
time frame: 3 months
description: The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
measure: Scar cosmesis
time frame: 6 months
description: The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
measure: Measurement of Scar Width
time frame: 3 months
description: The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.
measure: Measurement of Scar Width
time frame: 6 months
description: The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.
measure: Adverse Events
time frame: 15 days
description: Noting the presence or absence of dehiscence, infection or spitting sutures.
measure: Adverse Events
time frame: 1.5 months
description: Noting the presence or absence of dehiscence, infection or spitting sutures.
measure: Adverse Events
time frame: 3 months
description: Noting the presence or absence of dehiscence, infection or spitting sutures.
measure: Adverse Events
time frame: 6 months
description: Noting the presence or absence of dehiscence, infection or spitting sutures.
measure: Time spent suturing the wound
time frame: up to 24h
description: The time spent suturing each half of the scar will be recorded in minutes
measure: Number of suture thread needed
time frame: up to 24h
description: The number of threads used to suture each half of the scar will be recorded
arm group label: Running sutures
arm group type: Active Comparator
description: Deep layers will be closed using running sutures
arm group label: Interrupted sutures
arm group type: Experimental
description: Deep layers will be closed using interrupted sutures
intervention type: Other
intervention name: Running sutures
arm group label: Running sutures
intervention type: Other
intervention name: Interrupted sutures
arm group label: Interrupted sutures
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Fondation Hôpital Saint-Joseph
investigator full name: samer jabbour
investigator title: M.D.
mesh term: Body Weight
mesh term: Weight Loss