<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/NCT03010293</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0391</org_study_id>
    <nct_id>NCT03010293</nct_id>
  </id_info>
  <brief_title>Pressure Ulcer-associated Osteomyelitis: Evaluation of a Two-stage Surgical Strategy With Prolonged Antimicrobial Therapy</brief_title>
  <official_title>Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or&#xD;
      after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe&#xD;
      complication with a poorly known management, and is associated with a high rate of relapse,&#xD;
      leading to a high-burden in hospital bed-days, financial cost, surgical intervention,&#xD;
      antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone&#xD;
      and joint infection management, the medical and surgical strategies are systematically&#xD;
      discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical&#xD;
      strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction&#xD;
      using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to&#xD;
      evaluate this complex approach and to determine risk factors of treatment failure in order to&#xD;
      improve patient management, focusing on optimization of empirical antimicrobial therapy after&#xD;
      each surgical stage, delay between the two surgical stage, and duration of antimicrobial&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">February 15, 2017</completion_date>
  <primary_completion_date type="Actual">February 15, 2017</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>Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis</measure>
    <time_frame>2 years after antibiotic therapy disruption</time_frame>
    <description>Treatment failure will include: 1) local clinical and/or microbiological relapse; and/or 2) need for additional surgery after surgical reconstruction by muscular flap; and/or 3) death of septic origin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factor for treatment failure of a two-stage surgical strategy with prolonged antimicrobial therapy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis</measure>
    <time_frame>2 years after antibiotic therapy disruption</time_frame>
    <description>Risk factor for treatment failure will particularly focus on empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, optimization of local condition (including discharge, colostomy) and duration of antimicrobial therapy.</description>
  </secondary_outcome>
  <enrollment type="Actual">61</enrollment>
  <condition>Bone Diseases, Infectious</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with pressure ulcer-related osteomyelitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (i.e age ≥ 18 year-old) with a osteomyelitis complication following a&#xD;
             pressure ulcer who benefited from a two-stage surgical strategy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Tristan Ferry</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse</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>November 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antimicrobial therapy</keyword>
  <keyword>Debridement</keyword>
  <keyword>Osteomyelitis</keyword>
  <keyword>Muscular flap</keyword>
  <keyword>Pressure ulcer</keyword>
  <keyword>Treatment failure</keyword>
  <keyword>Vacuum-assisted closure therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Bone Diseases, Infectious</mesh_term>
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Pressure Ulcer</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/NCT03010293
org study id: 69HCL16_0391
nct id: NCT03010293
lead sponsor: 
has dmc: No
Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or
      after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe
      complication with a poorly known management, and is associated with a high rate of relapse,
      leading to a high-burden in hospital bed-days, financial cost, surgical intervention,
      antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone
      and joint infection management, the medical and surgical strategies are systematically
      discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical
      strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction
      using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to
      evaluate this complex approach and to determine risk factors of treatment failure in order to
      improve patient management, focusing on optimization of empirical antimicrobial therapy after
      each surgical stage, delay between the two surgical stage, and duration of antimicrobial
      therapy.
observational model: Cohort
time perspective: Retrospective
measure: Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
time frame: 2 years after antibiotic therapy disruption
description: Treatment failure will include: 1) local clinical and/or microbiological relapse; and/or 2) need for additional surgery after surgical reconstruction by muscular flap; and/or 3) death of septic origin.
measure: Risk factor for treatment failure of a two-stage surgical strategy with prolonged antimicrobial therapy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis
time frame: 2 years after antibiotic therapy disruption
description: Risk factor for treatment failure will particularly focus on empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, optimization of local condition (including discharge, colostomy) and duration of antimicrobial therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tristan Ferry
role: Principal Investigator
affiliation: Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse
facility: 
country: France
url: http://www.crioac-lyon.fr
description: Related Info
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Osteomyelitis
mesh term: Bone Diseases, Infectious
mesh term: Bone Diseases
mesh term: Pressure Ulcer