<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/NCT04455217</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00214; ch20Schaefer</org_study_id>
    <nct_id>NCT04455217</nct_id>
  </id_info>
  <brief_title>Long--term Outcome Analysis of Fracture--related Infections</brief_title>
  <acronym>Re_FRI</acronym>
  <official_title>Long--term Outcome Analysis of Fracture--related Infections (Re_FRI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This retrospective analysis of medical records is to identify risk factors for treatment&#xD;
      failures in fracture-associated infections (FAI) at the University Hospital Basel.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>number of flap failures at discharge from hospital</measure>
    <time_frame>at baseline</time_frame>
    <description>number of flap failures at discharge from hospital</description>
  </primary_outcome>
  <enrollment type="Actual">350</enrollment>
  <condition>Fracture-associated Infection (FAI)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection from patients with FAI (occuring January 2000 until December 2019)</intervention_name>
    <description>data collection from patient files (data regarding surgery, adverse events, infections, demographic data)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with FAI attending the University Hospital Basel from January 2000 until December&#xD;
        2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with FAI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  documented denial of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk Johannes Schaefer, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie; University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Morgenstern M, Erichsen C, Militz M, Xie Z, Peng J, Stannard J, Metsemakers WJ, Schaefer D, Alt V, Soballe K, Nerlich M, Buckley RE, Blauth M, Suk M, Leung F, Barla JD, Yukata K, Qing B, Kates SL. The AO trauma CPP bone infection registry: Epidemiology and outcomes of Staphylococcus aureus bone infection. J Orthop Res. 2021 Jan;39(1):136-146. doi: 10.1002/jor.24804. Epub 2020 Jul 27.</citation>
    <PMID>32720352</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prosthesis infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Fractures, Bone</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/NCT04455217
org study id: 2020-00214; ch20Schaefer
nct id: NCT04455217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective analysis of medical records is to identify risk factors for treatment
      failures in fracture-associated infections (FAI) at the University Hospital Basel.
observational model: Cohort
time perspective: Retrospective
measure: number of flap failures at discharge from hospital
time frame: at baseline
description: number of flap failures at discharge from hospital
intervention type: Other
intervention name: data collection from patients with FAI (occuring January 2000 until December 2019)
description: data collection from patient files (data regarding surgery, adverse events, infections, demographic data)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dirk Johannes Schaefer, Prof. Dr. med.
role: Principal Investigator
affiliation: Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie; University Hospital Basel
facility: 
country: Switzerland
citation: Morgenstern M, Erichsen C, Militz M, Xie Z, Peng J, Stannard J, Metsemakers WJ, Schaefer D, Alt V, Soballe K, Nerlich M, Buckley RE, Blauth M, Suk M, Leung F, Barla JD, Yukata K, Qing B, Kates SL. The AO trauma CPP bone infection registry: Epidemiology and outcomes of Staphylococcus aureus bone infection. J Orthop Res. 2021 Jan;39(1):136-146. doi: 10.1002/jor.24804. Epub 2020 Jul 27.
PMID: 32720352
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Fractures, Bone