<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/NCT01733940</url>
  </required_header>
  <id_info>
    <org_study_id>10/12</org_study_id>
    <nct_id>NCT01733940</nct_id>
  </id_info>
  <brief_title>Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing</brief_title>
  <acronym>EAC-UCI</acronym>
  <official_title>Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing in the Reduction of Central Catheter Colonization in Patients of the Intensive Care Unit of the University &quot;Gómez Ulla&quot; Hospital.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Central de la Defensa Gómez Ulla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Central de la Defensa Gómez Ulla</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in&#xD;
      intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can&#xD;
      decrease the catheters colonization, closely related to infection thereof.&#xD;
&#xD;
      Objective: To determine the efficacy of the dressing &quot;Tegaderm CHG&quot; dressings versus&#xD;
      &quot;Tegaderm IV&quot; dressings in reducing the risk of colonization of central intravascular&#xD;
      catheters in the intensive care unit (ICU).&#xD;
&#xD;
      Methods: Randomized controlled trial with blinding professional who reviews the main outcome.&#xD;
      The study included patients over 18 years, indicating the central intravascular catheter&#xD;
      implantation in the ICU or in the operating room, prior informed consent. Excluding subjects&#xD;
      with positive blood culture at the time of catheter implantation.&#xD;
&#xD;
      The estimated sample size is 398 patients, with a confidence level of 95% and a statistical&#xD;
      power of 80%. The study protocol was approved by the ethics committee of the hospital.&#xD;
&#xD;
      Be made prospectively followed subjects from study entry until catheter removal collecting&#xD;
      information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site&#xD;
      and removal, reason for withdrawal and microbiological information.&#xD;
&#xD;
      For statistical analysis, a model is adjusted multivariate logistic regression, determining&#xD;
      the interaction of variables with the likelihood ratio test and confusion by switching&#xD;
      between the crude and adjusted effect greater than 10%.&#xD;
&#xD;
      Results and conclusions: The recruitment has started in November 2012 and is scheduled for&#xD;
      completion in March 2013. This study will determine whether these new dressings are effective&#xD;
      in our environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of intravascular central catheter colonization.</measure>
    <time_frame>November 2012- March 2013</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of CHG Tegaderm ® dressings.</measure>
    <time_frame>up to 4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">398</enrollment>
  <condition>Intravascular Catheter Colonization</condition>
  <arm_group>
    <arm_group_label>&quot;Tegaderm CHG&quot; Dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm is receiving a clorhexidine dressing for intravascular catheters.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Tegaderm IV&quot; dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of tegaderm iv dressings for intravascular catheters. Change each 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Application of a dressing with clorhexidine gluconate in intravascular catheters.</intervention_name>
    <arm_group_label>&quot;Tegaderm CHG&quot; Dressing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Application of a dressing without clorhexidine gluconate</intervention_name>
    <arm_group_label>&quot;Tegaderm IV&quot; dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: over 18 years, indicating the central intravascular catheter&#xD;
        implantation in the ICU or in the operating room, prior informed consent -&#xD;
&#xD;
        Exclusion Criteria:positive blood culture at the time of catheter implantation.&#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_contact>
    <last_name>ana isabel lopez figueras, MD</last_name>
    <phone>0034911586958</phone>
    <phone_ext>22958</phone_ext>
    <email>alopfi1@oc.mde.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Central Hospital of the Defense</name>
      <address>
        <city>Madrid</city>
        <zip>28047</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ana isabel lopez figueras</last_name>
      <email>alopfi1@oc.mde.es</email>
    </contact>
    <investigator>
      <last_name>Ana isabel López figueras</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 27, 2012</last_update_submitted>
  <last_update_submitted_qc>November 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Central de la Defensa Gómez Ulla</investigator_affiliation>
    <investigator_full_name>ANA ISABEL LÓPEZ FIGUERAS</investigator_full_name>
    <investigator_title>MD. Facultative of the Preventive Medicine Department</investigator_title>
  </responsible_party>
  <!-- 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/NCT01733940
org study id: 10/12
nct id: NCT01733940
lead sponsor: 
has dmc: Yes
Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in
      intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can
      decrease the catheters colonization, closely related to infection thereof.

      Objective: To determine the efficacy of the dressing "Tegaderm CHG" dressings versus
      "Tegaderm IV" dressings in reducing the risk of colonization of central intravascular
      catheters in the intensive care unit (ICU).

      Methods: Randomized controlled trial with blinding professional who reviews the main outcome.
      The study included patients over 18 years, indicating the central intravascular catheter
      implantation in the ICU or in the operating room, prior informed consent. Excluding subjects
      with positive blood culture at the time of catheter implantation.

      The estimated sample size is 398 patients, with a confidence level of 95% and a statistical
      power of 80%. The study protocol was approved by the ethics committee of the hospital.

      Be made prospectively followed subjects from study entry until catheter removal collecting
      information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site
      and removal, reason for withdrawal and microbiological information.

      For statistical analysis, a model is adjusted multivariate logistic regression, determining
      the interaction of variables with the likelihood ratio test and confusion by switching
      between the crude and adjusted effect greater than 10%.

      Results and conclusions: The recruitment has started in November 2012 and is scheduled for
      completion in March 2013. This study will determine whether these new dressings are effective
      in our environment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Incidence of intravascular central catheter colonization.
time frame: November 2012- March 2013
measure: Adverse effects of CHG Tegaderm ® dressings.
time frame: up to 4 months
arm group label: "Tegaderm CHG" Dressing
arm group type: Experimental
description: This arm is receiving a clorhexidine dressing for intravascular catheters.
arm group label: "Tegaderm IV" dressing
arm group type: Active Comparator
description: Use of tegaderm iv dressings for intravascular catheters. Change each 7 days.
intervention type: Device
intervention name: Application of a dressing with clorhexidine gluconate in intravascular catheters.
arm group label: "Tegaderm CHG" Dressing
intervention type: Device
intervention name: Application of a dressing without clorhexidine gluconate
arm group label: "Tegaderm IV" dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ana isabel lopez figueras, MD
phone: 0034911586958
phone ext: 22958
email: alopfi1@oc.mde.es
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Central de la Defensa Gómez Ulla
investigator full name: ANA ISABEL LÓPEZ FIGUERAS
investigator title: MD. Facultative of the Preventive Medicine Department