<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/NCT03798171</url>
  </required_header>
  <id_info>
    <org_study_id>0077-18-TLV</org_study_id>
    <nct_id>NCT03798171</nct_id>
  </id_info>
  <brief_title>Reduction of Exit Site Infection in Peritoneal Dialysis Patients</brief_title>
  <official_title>Reduction of Exit Site Infection in Peritoneal Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In peritoneal dialysis patients, the presence of the catheter presents a risk of infection -&#xD;
      exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise&#xD;
      in exit-site infection associated with organisms derived from contaminated water. Therefore&#xD;
      we decided to change the exit-site care in our unit.&#xD;
&#xD;
      This is a prospective observational single center study, that compares exit-site infection&#xD;
      rated in peritoneal dialysis patients before and after our policy change for exit-site care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal&#xD;
      membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted&#xD;
      with one end in the abdomen and the other protruding from the skin, in order to allow fluid&#xD;
      exchange.&#xD;
&#xD;
      The presence of the catheter presents a risk of infection - exit site infection, tunnel&#xD;
      infection or peritonitis - a cause of morbidity and treatment failure.&#xD;
&#xD;
      Infection prevention is based, among other measures, on aseptic handeling of catheter&#xD;
      exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and&#xD;
      other organisms associated with contaminated water. Therefore we decided to change the&#xD;
      exit-site care in our unit. Similar to central catheters handeling, we decided to cover the&#xD;
      catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic&#xD;
      regimen.&#xD;
&#xD;
      This is a prospective observational single center study. All peritoneal dialysis patients in&#xD;
      our institue will be counseled about change in exit-site care. For prevention of water&#xD;
      exposure the patients will use stoma bags around the catheter during showers. After the&#xD;
      shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is&#xD;
      applied (Mupirocin) and dressed with a clean gauze.&#xD;
&#xD;
      The patients will be followed for 3 years for adverse events. The number of infectious&#xD;
      episodes will be recorded and compared to historical data (January 2015-December 2017).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Anticipated">May 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>exit-site infection rate</measure>
    <time_frame>36 months</time_frame>
    <description>number of exit-site infection during 3 years of follow up, compared to historical data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>peritonitis rate</measure>
    <time_frame>36 months</time_frame>
    <description>number of peritonitis episodes during 3 years of follow up, compared to historical data</description>
  </secondary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Peritoneal Dialysis Catheter Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        peritoneal dialysis patients in Tel Aviv Sourasky medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  peritoneal dialysis patients capable to sign an informed consent or have an official&#xD;
             guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient's refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Canter</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Orit Kliuk Ben Bassat, MD</last_name>
      <phone>97236973270</phone>
      <email>oritkl@tlvmc.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>michal roll</investigator_full_name>
    <investigator_title>Department of nephrology</investigator_title>
  </responsible_party>
  <keyword>peritoneal dialysis</keyword>
  <keyword>exit site</keyword>
  <keyword>infection</keyword>
  <keyword>peritonitis</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>
  </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/NCT03798171
org study id: 0077-18-TLV
nct id: NCT03798171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In peritoneal dialysis patients, the presence of the catheter presents a risk of infection -
      exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise
      in exit-site infection associated with organisms derived from contaminated water. Therefore
      we decided to change the exit-site care in our unit.

      This is a prospective observational single center study, that compares exit-site infection
      rated in peritoneal dialysis patients before and after our policy change for exit-site care.
Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal
      membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted
      with one end in the abdomen and the other protruding from the skin, in order to allow fluid
      exchange.

      The presence of the catheter presents a risk of infection - exit site infection, tunnel
      infection or peritonitis - a cause of morbidity and treatment failure.

      Infection prevention is based, among other measures, on aseptic handeling of catheter
      exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and
      other organisms associated with contaminated water. Therefore we decided to change the
      exit-site care in our unit. Similar to central catheters handeling, we decided to cover the
      catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic
      regimen.

      This is a prospective observational single center study. All peritoneal dialysis patients in
      our institue will be counseled about change in exit-site care. For prevention of water
      exposure the patients will use stoma bags around the catheter during showers. After the
      shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is
      applied (Mupirocin) and dressed with a clean gauze.

      The patients will be followed for 3 years for adverse events. The number of infectious
      episodes will be recorded and compared to historical data (January 2015-December 2017).
observational model: Case-Only
time perspective: Prospective
measure: exit-site infection rate
time frame: 36 months
description: number of exit-site infection during 3 years of follow up, compared to historical data
measure: peritonitis rate
time frame: 36 months
description: number of peritonitis episodes during 3 years of follow up, compared to historical data
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: michal roll
investigator title: Department of nephrology
mesh term: Infections
mesh term: Communicable Diseases