<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/NCT04496635</url>
  </required_header>
  <id_info>
    <org_study_id>CCR-VINCat 1</org_study_id>
    <nct_id>NCT04496635</nct_id>
  </id_info>
  <brief_title>Surveillance and Implementation of a Bundle of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat)</brief_title>
  <acronym>CCR-VINCat</acronym>
  <official_title>Evaluation of the Application and Efficacy of Prevention Measures for Surgical Site Infection in Elective Colorectal Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Granollers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Granollers</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>
      The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors surgical site&#xD;
      infection (SSI) in elective colorectal surgery since 2007 in 55 public and private acute care&#xD;
      hospitals. These hospitals perform active and prospective standardized surveillance of&#xD;
      elective colorectal resections. Post-discharge surveillance is mandatory at least up to 30&#xD;
      days after surgery. Hospitals are classified according to their size into three groups: &gt;500&#xD;
      hospital beds; 200-500 beds; &lt;200 beds.&#xD;
&#xD;
      Aim. To examine the effect on SSI rate of a specific preventative bundle in elective&#xD;
      colorectal surgery.&#xD;
&#xD;
      Methods. Pragmatic study using VINCat prospective colorectal database from 2007 to 2018. In&#xD;
      2016, a bundle of six preventative measures was recommended to the VINCat hospitals.&#xD;
&#xD;
      To compare the results of SSI before (baseline phase, BP) and after the bundle implementation&#xD;
      (implementation phase, IP) a logistic regression model has been established. The results will&#xD;
      be shown as Odds Ratio (OR) and the corresponding confidence intervalsCI95. The significance&#xD;
      level will be fixed at 5% (P &lt; 0.05).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surveillance. The VINCat Program was developed in the 2007 as the Nosocomial Infection&#xD;
      Surveillance system in Catalonia, covering a population of seven and a half million people.&#xD;
      The system is similar to other international reference programs, such as the National&#xD;
      Healthcare Safety Network (NHSN), and its described in detail on the VINCat website.&#xD;
      Hospitals carry out active and prospective standardized surveillance, and are classified&#xD;
      according to their number of beds into three groups: group 1 (500 beds); group 2 (200-500&#xD;
      beds); group 3 (200 beds). The staff performing surveillance had received training in the&#xD;
      VINCat surveillance methodology to ensure the collection of homogeneous, accurate data.&#xD;
&#xD;
      Surveillance is continued at least for 30 days after the operation. All public and private&#xD;
      participating hospitals report data voluntarily and receive feedback once a year.&#xD;
&#xD;
      Monitoring of colorectal surgery is performed prospectively and continued until a minimum of&#xD;
      100 interventions per year is reached in each hospital, although some centres include all&#xD;
      their yearly cases. Hospitals with less than 10 interventions per year are excluded.&#xD;
      Participating hospitals record the data on an Internet-based database.&#xD;
&#xD;
      Follow-up and post-discharge surveillance. Patients are followed up by trained infection&#xD;
      control staff. Active mandatory post-discharge surveillance is performed at least to day 30&#xD;
      post surgery by a multimodal approach including electronic review of clinical records&#xD;
      (primary and secondary care), checking readmissions, checking emergency visits, and reviewing&#xD;
      microbiological and radiological data.&#xD;
&#xD;
      Development of the colorectal surgical site infection program. In 2015, a multidisciplinary&#xD;
      team of nurses and medical specialists from the VINCat Program, and surgeons belonging to the&#xD;
      Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative&#xD;
      measures for colorectal surgery. The literature for optimal care during the preoperative,&#xD;
      intraoperative and postoperative phases was reviewed, including evidence on oral antibiotic&#xD;
      prophylaxis and mechanical bowel preparation. Practices were chosen either by their high&#xD;
      levels of scientific evidence or by being considered, by consensus, reasonable, associated&#xD;
      with minimal risk, and potentially beneficial.&#xD;
&#xD;
      The working group developed a 6 measures bundle to be voluntary implemented by the&#xD;
      participating hospitals. The measures of the bundle are: intravenous and oral antibiotic&#xD;
      prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of&#xD;
      normothermia, and the use of a wound retractor.&#xD;
&#xD;
      The intervention began on 1 January 2016, with diffusion of the bundle measures via e-mail,&#xD;
      and a workshop addressed to all to the surgical and ICT teams.&#xD;
&#xD;
      Definitions. SSI is defined according to the Centers for Disease Control (CDC) and is&#xD;
      stratified into categories of surgical procedures (-1 to 3) according to the risk of surgical&#xD;
      infection defined by the NHSN.&#xD;
&#xD;
      Design of the pragmatic trial. Implementation of the bundle precluded randomization. The&#xD;
      study compared two phases: baseline (BP), from 2008 to 2015, and implementation (IP), from&#xD;
      2016 to 2018.&#xD;
&#xD;
      Fifty-five of the 66 hospitals participating in the VINCat Program were included in the&#xD;
      analysis. Prospective surveillance was performed by the infection control team (ICT) of each&#xD;
      hospital to ensure appropriate data collection. The surveillance period lasted from January&#xD;
      2007 to December 2018. During the first 4 years of the program, the results of colon and&#xD;
      rectal surgery were aggregated. From 2011, data is separated for each type of surgery.&#xD;
&#xD;
      As all eligible patients were included in the pragmatic design, informed consent was not&#xD;
      obtained.&#xD;
&#xD;
      The study was conducted as a performance improvement project and approved by the Ethics in&#xD;
      Research Committee.&#xD;
&#xD;
      Statistical analysis Data will be summarized as frequencies and proportions for categorical&#xD;
      variables or as medians and interquartile range (IQR) for continuous variables. Infection&#xD;
      rates will be expressed as cumulative incidence, that is, the crude percentage of operations&#xD;
      resulting in SSI/ number of surgery procedures. Data will be also stratified by year, risk&#xD;
      index category, hospital group and SSI type.&#xD;
&#xD;
      To analyse the relationship between two qualitative variables, contingency tables will be&#xD;
      used, and the chi-square test or the likelihood ratio test will be performed. The analysis&#xD;
      will be completed with grouped bar graphs. To analyse differences in the proportion of&#xD;
      infection over the years, the logistic regression model will be performed. The results will&#xD;
      be presented in terms of OR or estimated infection rates, with the corresponding 95%&#xD;
      confidence intervals. The significance level will be set at 5% in all tests. The results will&#xD;
      be analysed using software: Statistical Analysis Systems (SAS) v9.4, SAS Institute Inc.,&#xD;
      Cary, USA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2007</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>The study compare two phases: baseline (BP), from 2008 to 2015, and implementation (IP), from 2016 to 2018.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical site infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>Overall surgical infection rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Organ/space surgical infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>Specific organ/space surgical infection rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital type-Surgical infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>Comparison of rates among the three hospitals groups, according to their size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis (logistic regression model) of the efficacy of each preventive measure</measure>
    <time_frame>30 days</time_frame>
    <description>Univariate and multivariate logistic regression to analise the efficacy of each individual measure belonging to the bundle of care.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60000</enrollment>
  <condition>Colon Rectal Cancer</condition>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Baseline phase</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients included in the VINCat program, and operated on colorectal surgery between 2007 and 2015 in Catalonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Implementation phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients included in the VINCat program, and operated on colorectal surgery between 2016 and 2018 in Catalonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implementation of a bundle of care</intervention_name>
    <arm_group_label>Implementation phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colon or rectal elective surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peritonitis at the time of intervention (&quot;dirty&quot; surgery) Patients who underwent&#xD;
             multiple procedures during the same surgery, for example resection of liver metastases&#xD;
             Centers that performed less tan 10 surgical procedures annually Centers that have not&#xD;
             been able to ensure prospective surveillance during hospitalization or effective&#xD;
             monitoring of cases within 30 days of the intervention&#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>Josep M Badia-Perez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Hospital General de Granollers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gemma Molist, MD, PHD</last_name>
    <phone>+348425000</phone>
    <email>gmolist@fphag.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Josep M Badia, MD, PhD</last_name>
    <phone>+34670702099</phone>
    <email>jmbadiaperez@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital General de Granollers</name>
      <address>
        <city>Granollers</city>
        <state>Barcelona</state>
        <zip>08402</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josep M Badia</last_name>
      <phone>670702099</phone>
      <email>jmbadiaperez@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surveillance</keyword>
  <keyword>Preventative measures</keyword>
  <keyword>Bundle of care</keyword>
  <keyword>Colorectal surgery</keyword>
  <keyword>Surgical site infection</keyword>
  <keyword>Prevention</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be shared when requested</ipd_description>
  </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/NCT04496635
org study id: CCR-VINCat 1
nct id: NCT04496635
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors surgical site
      infection (SSI) in elective colorectal surgery since 2007 in 55 public and private acute care
      hospitals. These hospitals perform active and prospective standardized surveillance of
      elective colorectal resections. Post-discharge surveillance is mandatory at least up to 30
      days after surgery. Hospitals are classified according to their size into three groups: >500
      hospital beds; 200-500 beds; <200 beds.

      Aim. To examine the effect on SSI rate of a specific preventative bundle in elective
      colorectal surgery.

      Methods. Pragmatic study using VINCat prospective colorectal database from 2007 to 2018. In
      2016, a bundle of six preventative measures was recommended to the VINCat hospitals.

      To compare the results of SSI before (baseline phase, BP) and after the bundle implementation
      (implementation phase, IP) a logistic regression model has been established. The results will
      be shown as Odds Ratio (OR) and the corresponding confidence intervalsCI95. The significance
      level will be fixed at 5% (P < 0.05).
Surveillance. The VINCat Program was developed in the 2007 as the Nosocomial Infection
      Surveillance system in Catalonia, covering a population of seven and a half million people.
      The system is similar to other international reference programs, such as the National
      Healthcare Safety Network (NHSN), and its described in detail on the VINCat website.
      Hospitals carry out active and prospective standardized surveillance, and are classified
      according to their number of beds into three groups: group 1 (500 beds); group 2 (200-500
      beds); group 3 (200 beds). The staff performing surveillance had received training in the
      VINCat surveillance methodology to ensure the collection of homogeneous, accurate data.

      Surveillance is continued at least for 30 days after the operation. All public and private
      participating hospitals report data voluntarily and receive feedback once a year.

      Monitoring of colorectal surgery is performed prospectively and continued until a minimum of
      100 interventions per year is reached in each hospital, although some centres include all
      their yearly cases. Hospitals with less than 10 interventions per year are excluded.
      Participating hospitals record the data on an Internet-based database.

      Follow-up and post-discharge surveillance. Patients are followed up by trained infection
      control staff. Active mandatory post-discharge surveillance is performed at least to day 30
      post surgery by a multimodal approach including electronic review of clinical records
      (primary and secondary care), checking readmissions, checking emergency visits, and reviewing
      microbiological and radiological data.

      Development of the colorectal surgical site infection program. In 2015, a multidisciplinary
      team of nurses and medical specialists from the VINCat Program, and surgeons belonging to the
      Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative
      measures for colorectal surgery. The literature for optimal care during the preoperative,
      intraoperative and postoperative phases was reviewed, including evidence on oral antibiotic
      prophylaxis and mechanical bowel preparation. Practices were chosen either by their high
      levels of scientific evidence or by being considered, by consensus, reasonable, associated
      with minimal risk, and potentially beneficial.

      The working group developed a 6 measures bundle to be voluntary implemented by the
      participating hospitals. The measures of the bundle are: intravenous and oral antibiotic
      prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of
      normothermia, and the use of a wound retractor.

      The intervention began on 1 January 2016, with diffusion of the bundle measures via e-mail,
      and a workshop addressed to all to the surgical and ICT teams.

      Definitions. SSI is defined according to the Centers for Disease Control (CDC) and is
      stratified into categories of surgical procedures (-1 to 3) according to the risk of surgical
      infection defined by the NHSN.

      Design of the pragmatic trial. Implementation of the bundle precluded randomization. The
      study compared two phases: baseline (BP), from 2008 to 2015, and implementation (IP), from
      2016 to 2018.

      Fifty-five of the 66 hospitals participating in the VINCat Program were included in the
      analysis. Prospective surveillance was performed by the infection control team (ICT) of each
      hospital to ensure appropriate data collection. The surveillance period lasted from January
      2007 to December 2018. During the first 4 years of the program, the results of colon and
      rectal surgery were aggregated. From 2011, data is separated for each type of surgery.

      As all eligible patients were included in the pragmatic design, informed consent was not
      obtained.

      The study was conducted as a performance improvement project and approved by the Ethics in
      Research Committee.

      Statistical analysis Data will be summarized as frequencies and proportions for categorical
      variables or as medians and interquartile range (IQR) for continuous variables. Infection
      rates will be expressed as cumulative incidence, that is, the crude percentage of operations
      resulting in SSI/ number of surgery procedures. Data will be also stratified by year, risk
      index category, hospital group and SSI type.

      To analyse the relationship between two qualitative variables, contingency tables will be
      used, and the chi-square test or the likelihood ratio test will be performed. The analysis
      will be completed with grouped bar graphs. To analyse differences in the proportion of
      infection over the years, the logistic regression model will be performed. The results will
      be presented in terms of OR or estimated infection rates, with the corresponding 95%
      confidence intervals. The significance level will be set at 5% in all tests. The results will
      be analysed using software: Statistical Analysis Systems (SAS) v9.4, SAS Institute Inc.,
      Cary, USA.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: The study compare two phases: baseline (BP), from 2008 to 2015, and implementation (IP), from 2016 to 2018.
primary purpose: Prevention
masking: None (Open Label)
measure: Surgical site infection rate
time frame: 30 days
description: Overall surgical infection rate
measure: Organ/space surgical infection rate
time frame: 30 days
description: Specific organ/space surgical infection rate
measure: Hospital type-Surgical infection rate
time frame: 30 days
description: Comparison of rates among the three hospitals groups, according to their size
measure: Analysis (logistic regression model) of the efficacy of each preventive measure
time frame: 30 days
description: Univariate and multivariate logistic regression to analise the efficacy of each individual measure belonging to the bundle of care.
arm group label: Baseline phase
arm group type: No Intervention
description: Patients included in the VINCat program, and operated on colorectal surgery between 2007 and 2015 in Catalonia
arm group label: Implementation phase
arm group type: Experimental
description: Patients included in the VINCat program, and operated on colorectal surgery between 2016 and 2018 in Catalonia
intervention type: Other
intervention name: Implementation of a bundle of care
arm group label: Implementation phase
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Josep M Badia-Perez, MD, PhD
role: Principal Investigator
affiliation: Fundació Hospital General de Granollers
last name: Gemma Molist, MD, PHD
phone: +348425000
email: gmolist@fphag.org
last name: Josep M Badia, MD, PhD
phone: +34670702099
email: jmbadiaperez@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
sharing ipd: No
ipd description: Data will be shared when requested