<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/NCT04423250</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2016/JMK-01</org_study_id>
    <nct_id>NCT04423250</nct_id>
  </id_info>
  <brief_title>Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical deviceS</brief_title>
  <acronym>OPTIBLOC</acronym>
  <official_title>Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <brief_summary>
    <textblock>
      assess the impact of the intervention of a clinical pharmacist expert in sterile medical&#xD;
      devices&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2018</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>identify compliance with the appropriate use of sterile medical devices</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices</intervention_name>
    <description>- Failure to trace, Lack of product information, absence of product in the operating room</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized for scheduled surgery in the UDG (Urology Digestive Gynecology)&#xD;
        operating room.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - The patient must be a member or beneficiary of a health insurance plan.&#xD;
&#xD;
          -  The patient is managed for scheduled surgery (full hospitalization or outpatient) in&#xD;
             the UDG (Urology Digestive Gynecology) operating room.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - The subject is in a period of exclusion determined by a previous study.&#xD;
&#xD;
          -  The subject is under judicial protection.&#xD;
&#xD;
          -  The subject (or his/her legal representative) has expressed his/her opposition to&#xD;
             participate in the study.&#xD;
&#xD;
          -  The patient is undergoing emergency surgery in the UDG (Urology Digestive Gynecology)&#xD;
             operating room.&#xD;
&#xD;
          -  It is not possible to give informed information about the subject.&#xD;
&#xD;
        Translated with www.DeepL.com/Translator (free version)&#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>CHU de NIMES</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT04423250
org study id: NIMAO/2016/JMK-01
nct id: NCT04423250
lead sponsor: 
assess the impact of the intervention of a clinical pharmacist expert in sterile medical
      devices
observational model: Cohort
time perspective: Other
measure: identify compliance with the appropriate use of sterile medical devices
time frame: 1 day
intervention type: Other
intervention name: impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices
description: - Failure to trace, Lack of product information, absence of product in the operating room
study pop: 
sampling method: Non-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: Infertility