<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/NCT04418882</url>
  </required_header>
  <id_info>
    <org_study_id>20-204</org_study_id>
    <nct_id>NCT04418882</nct_id>
  </id_info>
  <brief_title>Septic Management and Outcome of Open Fracture</brief_title>
  <official_title>Septic Management and Outcome of Open Fracture : a 7 Years Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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 aim is the study of the management and outcome of the open fractures.&#xD;
&#xD;
      Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.&#xD;
&#xD;
      The management and evolution of all the open fractures will be described in order to identify&#xD;
      the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non&#xD;
      septic).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 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>description of non septic open fracture</measure>
    <time_frame>24 months</time_frame>
    <description>description of surgical management</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of patients with non septic open fracture</measure>
    <time_frame>1 month</time_frame>
    <description>description of patients : average age, medical background</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of septic open fracture : bacteriology</measure>
    <time_frame>24 months</time_frame>
    <description>type of bacteria involved in the infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of septic open fracture : evolution</measure>
    <time_frame>24 months</time_frame>
    <description>description of symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of septic open fracture : management</measure>
    <time_frame>24 months</time_frame>
    <description>description of surgical and medical management</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of septic open fracture : patients</measure>
    <time_frame>24 months</time_frame>
    <description>description of patients : average age, medical background</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of pseudarthrosis: symptoms</measure>
    <time_frame>24 months</time_frame>
    <description>description of symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of pseudarthrosis : management</measure>
    <time_frame>24 months</time_frame>
    <description>description of management: surgical and medical management</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of septic pseudarthrosis : patients</measure>
    <time_frame>24 months</time_frame>
    <description>description of patients : average age, medical background</description>
  </primary_outcome>
  <primary_outcome>
    <measure>description of septic pseudarthrosis : bacteriology</measure>
    <time_frame>24 months</time_frame>
    <description>type of bacteria involved in the infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>treatment failure</measure>
    <time_frame>24 months</time_frame>
    <description>rate and description of treatment failure.Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Open Fracture</condition>
  <condition>Pseudarthrosis</condition>
  <condition>Bone and Joint Infection</condition>
  <arm_group>
    <arm_group_label>non septic open fracture</arm_group_label>
    <description>patients having had an open fracture without septic evolution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>septic open fracture</arm_group_label>
    <description>patients having had an open fracture with septic evolution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>management and follow up of all open fractures</intervention_name>
    <description>to evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too.</description>
    <arm_group_label>non septic open fracture</arm_group_label>
    <arm_group_label>septic open fracture</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having had an open fractures managed at the HCL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with open fractures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.crioac-lyon.fr</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone and joint infection</keyword>
  <keyword>Pseudarthrosis</keyword>
  <keyword>Open Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Fractures, Open</mesh_term>
    <mesh_term>Pseudarthrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04418882
org study id: 20-204
nct id: NCT04418882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is the study of the management and outcome of the open fractures.

      Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.

      The management and evolution of all the open fractures will be described in order to identify
      the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non
      septic).
observational model: Cohort
time perspective: Retrospective
measure: description of non septic open fracture
time frame: 24 months
description: description of surgical management
measure: description of patients with non septic open fracture
time frame: 1 month
description: description of patients : average age, medical background
measure: description of septic open fracture : bacteriology
time frame: 24 months
description: type of bacteria involved in the infection
measure: description of septic open fracture : evolution
time frame: 24 months
description: description of symptoms
measure: description of septic open fracture : management
time frame: 24 months
description: description of surgical and medical management
measure: description of septic open fracture : patients
time frame: 24 months
description: description of patients : average age, medical background
measure: description of pseudarthrosis: symptoms
time frame: 24 months
description: description of symptoms
measure: description of pseudarthrosis : management
time frame: 24 months
description: description of management: surgical and medical management
measure: description of septic pseudarthrosis : patients
time frame: 24 months
description: description of patients : average age, medical background
measure: description of septic pseudarthrosis : bacteriology
time frame: 24 months
description: type of bacteria involved in the infection
measure: treatment failure
time frame: 24 months
description: rate and description of treatment failure.Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
arm group label: non septic open fracture
description: patients having had an open fracture without septic evolution
arm group label: septic open fracture
description: patients having had an open fracture with septic evolution
intervention type: Other
intervention name: management and follow up of all open fractures
description: to evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too.
arm group label: non septic open fracture
arm group label: septic open fracture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
url: http://www.crioac-lyon.fr
description: Related Info
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Fractures, Open
mesh term: Pseudarthrosis
sharing ipd: Undecided