<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/NCT04492826</url>
  </required_header>
  <id_info>
    <org_study_id>20_5052</org_study_id>
    <nct_id>NCT04492826</nct_id>
  </id_info>
  <brief_title>Postoperative Surgical Site Infection afterENT Bone Flap Surgery</brief_title>
  <acronym>SSI-flap</acronym>
  <official_title>Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2017, the French Society in anesthesia and reanimation published new recommendations on&#xD;
      intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis&#xD;
      applies to any otolaryngology surgery, regardless of patient's medical history or type of&#xD;
      flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse&#xD;
      hospital.&#xD;
&#xD;
      However, after few years, our local impressions are that bone flap surgeries are very likely&#xD;
      to provide surgical site infections (osteo-articular or non-osteo-articular infections).&#xD;
&#xD;
      The prejudice of these postoperative site infections is significant, with serious&#xD;
      consequences,. of both functional and aesthetic sides.&#xD;
&#xD;
      We wanted to objectify this impression by retrospectively analyzing the data relating to&#xD;
      patients operated on for bone flapsurgeries.&#xD;
&#xD;
      Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery&#xD;
      will allow us to objectively understand the infectious risk of these surgeries, in particular&#xD;
      the risk of osteoarticular infection. Identifying operation site infection factors will allow&#xD;
      us to better target and prevent them.&#xD;
&#xD;
      The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and&#xD;
      effective for this type of surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative infections rate after otolaryngology bone flap surgery</measure>
    <time_frame>1 year</time_frame>
    <description>Assess the postoperative infection rate after bone flap otolaryngology surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Rate of Infections</condition>
  <condition>Operating Site</condition>
  <condition>Post-operative Surgery</condition>
  <condition>Bone Flap Surgery</condition>
  <condition>Otolaryngology</condition>
  <arm_group>
    <arm_group_label>Infected patients</arm_group_label>
    <description>patients with bone flap surgeries</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Postoperative infections rate</intervention_name>
    <description>Assess the postoperative infection rate after otolaryngology bone flap surgery.</description>
    <arm_group_label>Infected patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient operated on for bone flap surgery by the Otorhinolaryngology surgery team in&#xD;
        Croix-Rousse hospital (Pr CERUSE)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient operated for bone flap in Croix-Rousse hospital, in otorhinolaryngology&#xD;
             department, since september 2012 and until January 2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient's opposition to participate in the study&#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>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>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone flap surgery</keyword>
  <keyword>postoperative surgical 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>Surgical Wound Infection</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/NCT04492826
org study id: 20_5052
nct id: NCT04492826
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In 2017, the French Society in anesthesia and reanimation published new recommendations on
      intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis
      applies to any otolaryngology surgery, regardless of patient's medical history or type of
      flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse
      hospital.

      However, after few years, our local impressions are that bone flap surgeries are very likely
      to provide surgical site infections (osteo-articular or non-osteo-articular infections).

      The prejudice of these postoperative site infections is significant, with serious
      consequences,. of both functional and aesthetic sides.

      We wanted to objectify this impression by retrospectively analyzing the data relating to
      patients operated on for bone flapsurgeries.

      Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery
      will allow us to objectively understand the infectious risk of these surgeries, in particular
      the risk of osteoarticular infection. Identifying operation site infection factors will allow
      us to better target and prevent them.

      The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and
      effective for this type of surgery.
observational model: Case-Only
time perspective: Retrospective
measure: Postoperative infections rate after otolaryngology bone flap surgery
time frame: 1 year
description: Assess the postoperative infection rate after bone flap otolaryngology surgery
arm group label: Infected patients
description: patients with bone flap surgeries
intervention type: Procedure
intervention name: Postoperative infections rate
description: Assess the postoperative infection rate after otolaryngology bone flap surgery.
arm group label: Infected patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection