<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/NCT03759652</url>
  </required_header>
  <id_info>
    <org_study_id>PTZS Neurosurgery 2018</org_study_id>
    <nct_id>NCT03759652</nct_id>
  </id_info>
  <brief_title>Surgical and Non-surgical Infections of Neurosurgical Patient: Before-after Cohort Study</brief_title>
  <official_title>Surveillance of Surgical Site Infections and Non-surgical Infections of Neurosurgical Patient. Retrospective Before-after Cohort Study at a Tertiary Care Hospital in Poland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polskie Towarzystwo Zakażeń Szpitalnych</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polskie Towarzystwo Zakażeń Szpitalnych</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>
      Continuous surveillance in 2003-2017 allowed to detect HAIs in patients staying in a 42-bed&#xD;
      neurosurgery unit with 6 intensive neurosurgical supervision beds. 10,332 surgical patients&#xD;
      were qualified for the study. The study was carried out in the framework of a national&#xD;
      surveillance of HAI programme following methodology recommended by Healthcare-Associated&#xD;
      Infections Surveillance Network (HAI-Net), European Centre for Disease Prevention and&#xD;
      Control. Intervention in this before-after study (2003-2017) comprised standardised&#xD;
      surveillance of HAI with regular analysis and feedback.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Supervision of HAIs was carried out in the neurosurgery unit in 2003-2017 in St. Luke&#xD;
      Provincial Hospital in Tarnów, Poland. The department offers 42 hospital beds (including 6&#xD;
      intensive supervision beds, where mechanical ventilation is also used). Patients in very poor&#xD;
      clinical condition do not stay in this department as they are generally sent to a separate&#xD;
      general intensive care unit. Active surveillance of infections was implemented in the&#xD;
      hospital in 2001 and the experiences concerning the neurosurgery unit were already the&#xD;
      subject of previous general analyses not including trend analysis or detailed analyses of&#xD;
      various HAI clinical forms [Wałaszek NCH 2015]. The Infection Control Team consists of a&#xD;
      doctor, who is employed on a 1/3 full-time equivalent basis and 4 full-time epidemiological&#xD;
      nurses.&#xD;
&#xD;
      The data analysed involve the time when the unit in question began targeted, active&#xD;
      surveillance of infections, initially: 2003-2012, using tools (definitions, protocols) in&#xD;
      accordance with the National Healthcare Safety Network (NHSN) [Emori, NNIS], then from 2012,&#xD;
      HAI recognition methodology and HAI record-keeping has followed the Surveillance Network&#xD;
      (HAI-Net), European Centre for Disease Prevention and Control (ECDC) [ECDC 4.3, 2012; HAI-Net&#xD;
      ICU 1.02. ECDC; 2015]. For the purposes of this analysis, HAI cases originally qualified in&#xD;
      2002-2012 according to the NHSN criteria were retrospectively subjected to reclassification&#xD;
      according to the ECDC definitions from 2012 (they concerned BSI, PN and UTI), hence, all HAI&#xD;
      cases were qualified into individual HAI categories according to the ECDC case definition&#xD;
      keeping the division into: catheter-related BSI and BSI secondary to another infection, five&#xD;
      subcategories of PN and three forms of SSI. The surgeries performed were stratified by type&#xD;
      of operation conforming to the International Classification of Procedures in Medicine ICD&#xD;
      9-CM, according to the NHSN code (International Classification of Diseases) (Supplementarty&#xD;
      Material, Table 1).&#xD;
&#xD;
      Beginning in 2003, changes were being implemented as regards supervision of infections by the&#xD;
      Infection Control Team together with the staff of the departments (neurosurgery, operating&#xD;
      block and infection control team), which encompassed, among others:&#xD;
&#xD;
        1. hospital admission rules for shortening of the pre-operative stay and optimal patient&#xD;
           preparation for surgery to limit emergency surgery; preparation of the surgical team&#xD;
&#xD;
        2. work organization of the operating block: among others, preoperative checklist, surgical&#xD;
           hand hygiene, preparation of the operating field and surgical drape, application of&#xD;
           antiseptic to the edges of the wound before sewing it;&#xD;
&#xD;
        3. perioperative procedure: patient preparation for surgery, among others, bathing the&#xD;
           patient immediately prior to surgery, hair removal, changing the bed linen and patient's&#xD;
           clothing immediately before surgery, patient care during the postoperative period, and&#xD;
           above all, the 5 moments for hand hygiene and post-operative dressing and wound control.&#xD;
&#xD;
      In addition: regular analysis and feedback have also been implemented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2003</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>incidence of surgical site infection</measure>
    <time_frame>2003-2017</time_frame>
    <description>the cumulative incidence of surgical site infection (SSI) was calculated by dividing the number of SSI cases by the number of patients undergoing surgery and multiplying by 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of pneumonia</measure>
    <time_frame>2003-2017</time_frame>
    <description>the cumulative incidence of post-procedure pneumonia was calculated by dividing the number of pneumonia cases by the number of patients undergoing surgery and multiplying by 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of bloodstream infections</measure>
    <time_frame>2003-2017</time_frame>
    <description>the cumulative incidence of bloodstream infections (BSI) was calculated by dividing the number of BSI cases by the number of patients undergoing surgery and multiplying by 100</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10332</enrollment>
  <condition>Neurosurgery</condition>
  <arm_group>
    <arm_group_label>infected, before-after studyt: 2003</arm_group_label>
    <description>neurosurgical patients; 2003: the beggining of active and target HAI surveillance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>infected, before-after studyt: 2017</arm_group_label>
    <description>neurosurgical patients; 2017: the effective of active and target HAI surveillance</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>before-after study</intervention_name>
    <description>The data analysed involve the time when the targeted, active surveillance of infections was establised, initially: 2003-2017, using tools (definitions, protocols) in accordance with the National Healthcare Safety Network (NHSN), then from 2012, HAI recognition methodology and HAI record-keeping has followed the Surveillance Network (HAI-Net), European Centre for Disease Prevention and Control (ECDC).</description>
    <arm_group_label>infected, before-after studyt: 2003</arm_group_label>
    <arm_group_label>infected, before-after studyt: 2017</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery in the Neurosurgery Ward in St. Luke Provincial Hospital in&#xD;
        Tarnów, Poland, in 2003-2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of neurosurgical disorders&#xD;
&#xD;
          -  requiring surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        patients without surgery intervention&#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>Jadwiga Wójkowska-Mach</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jagiellonian University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jagiellonian University Medical School</name>
      <address>
        <city>Kraków</city>
        <zip>31-121</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neurosurgery</keyword>
  <keyword>surgical site infections</keyword>
  <keyword>spinal surgery</keyword>
  <keyword>craniotomy</keyword>
  <keyword>laminectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03759652
org study id: PTZS Neurosurgery 2018
nct id: NCT03759652
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Continuous surveillance in 2003-2017 allowed to detect HAIs in patients staying in a 42-bed
      neurosurgery unit with 6 intensive neurosurgical supervision beds. 10,332 surgical patients
      were qualified for the study. The study was carried out in the framework of a national
      surveillance of HAI programme following methodology recommended by Healthcare-Associated
      Infections Surveillance Network (HAI-Net), European Centre for Disease Prevention and
      Control. Intervention in this before-after study (2003-2017) comprised standardised
      surveillance of HAI with regular analysis and feedback.
Supervision of HAIs was carried out in the neurosurgery unit in 2003-2017 in St. Luke
      Provincial Hospital in Tarnów, Poland. The department offers 42 hospital beds (including 6
      intensive supervision beds, where mechanical ventilation is also used). Patients in very poor
      clinical condition do not stay in this department as they are generally sent to a separate
      general intensive care unit. Active surveillance of infections was implemented in the
      hospital in 2001 and the experiences concerning the neurosurgery unit were already the
      subject of previous general analyses not including trend analysis or detailed analyses of
      various HAI clinical forms [Wałaszek NCH 2015]. The Infection Control Team consists of a
      doctor, who is employed on a 1/3 full-time equivalent basis and 4 full-time epidemiological
      nurses.

      The data analysed involve the time when the unit in question began targeted, active
      surveillance of infections, initially: 2003-2012, using tools (definitions, protocols) in
      accordance with the National Healthcare Safety Network (NHSN) [Emori, NNIS], then from 2012,
      HAI recognition methodology and HAI record-keeping has followed the Surveillance Network
      (HAI-Net), European Centre for Disease Prevention and Control (ECDC) [ECDC 4.3, 2012; HAI-Net
      ICU 1.02. ECDC; 2015]. For the purposes of this analysis, HAI cases originally qualified in
      2002-2012 according to the NHSN criteria were retrospectively subjected to reclassification
      according to the ECDC definitions from 2012 (they concerned BSI, PN and UTI), hence, all HAI
      cases were qualified into individual HAI categories according to the ECDC case definition
      keeping the division into: catheter-related BSI and BSI secondary to another infection, five
      subcategories of PN and three forms of SSI. The surgeries performed were stratified by type
      of operation conforming to the International Classification of Procedures in Medicine ICD
      9-CM, according to the NHSN code (International Classification of Diseases) (Supplementarty
      Material, Table 1).

      Beginning in 2003, changes were being implemented as regards supervision of infections by the
      Infection Control Team together with the staff of the departments (neurosurgery, operating
      block and infection control team), which encompassed, among others:

        1. hospital admission rules for shortening of the pre-operative stay and optimal patient
           preparation for surgery to limit emergency surgery; preparation of the surgical team

        2. work organization of the operating block: among others, preoperative checklist, surgical
           hand hygiene, preparation of the operating field and surgical drape, application of
           antiseptic to the edges of the wound before sewing it;

        3. perioperative procedure: patient preparation for surgery, among others, bathing the
           patient immediately prior to surgery, hair removal, changing the bed linen and patient's
           clothing immediately before surgery, patient care during the postoperative period, and
           above all, the 5 moments for hand hygiene and post-operative dressing and wound control.

      In addition: regular analysis and feedback have also been implemented.
observational model: Cohort
time perspective: Retrospective
measure: incidence of surgical site infection
time frame: 2003-2017
description: the cumulative incidence of surgical site infection (SSI) was calculated by dividing the number of SSI cases by the number of patients undergoing surgery and multiplying by 100
measure: incidence of pneumonia
time frame: 2003-2017
description: the cumulative incidence of post-procedure pneumonia was calculated by dividing the number of pneumonia cases by the number of patients undergoing surgery and multiplying by 100
measure: incidence of bloodstream infections
time frame: 2003-2017
description: the cumulative incidence of bloodstream infections (BSI) was calculated by dividing the number of BSI cases by the number of patients undergoing surgery and multiplying by 100
arm group label: infected, before-after studyt: 2003
description: neurosurgical patients; 2003: the beggining of active and target HAI surveillance
arm group label: infected, before-after studyt: 2017
description: neurosurgical patients; 2017: the effective of active and target HAI surveillance
intervention type: Behavioral
intervention name: before-after study
description: The data analysed involve the time when the targeted, active surveillance of infections was establised, initially: 2003-2017, using tools (definitions, protocols) in accordance with the National Healthcare Safety Network (NHSN), then from 2012, HAI recognition methodology and HAI record-keeping has followed the Surveillance Network (HAI-Net), European Centre for Disease Prevention and Control (ECDC).
arm group label: infected, before-after studyt: 2003
arm group label: infected, before-after studyt: 2017
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jadwiga Wójkowska-Mach
role: Principal Investigator
affiliation: Jagiellonian University Medical School
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Infections
sharing ipd: No