xml: <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/NCT05995080</url>
    </required_header>
    <id_info>
      <org_study_id>0009-0009-3168-4445</org_study_id>
      <nct_id>NCT05995080</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Chlorhexidine Gluconate on Prevention of Catheter-Related Bloodstream Infections</brief_title>
    <official_title>The Effectiveness of Chlorhexidine Gluconate Bathing on Prevention of Catheter-Related Bloodstream Infections in Pediatric Intensive Care Unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medeniyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medeniyet University</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>
        Catheter-related bloodstream infections are associated with increased mortality, morbidity,&#xD;
        and length of hospital stay. The incidence has decreased significantly with the strict&#xD;
        implementation of preventive bundle cares and checklists in intensive care units. Bathing&#xD;
        with solutions containing chlorhexidine has been included in preventive strategies in recent&#xD;
        years. Although some studies have shown that chlorhexidine bathing reduces the frequency of&#xD;
        hospital-associated infections, there are important differences in management of practice and&#xD;
        adherence to practice in different facilities. The majority of the studies conducted include&#xD;
        adult patients. According to the CDC guidelines, chlorhexidine bathing is recommended for&#xD;
        children over 2 months of age to prevent catheter-related bloodstream infection. The aim of&#xD;
        this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate&#xD;
        solution in preventing catheter-related bloodstream infections in pediatric patients with&#xD;
        temporary central venous catheters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream&#xD;
        infection will be recorded as laboratory-confirmed bloodstream infections according to CDC&#xD;
        diagnostic criteria. Microorganisms detected in cultures will be classified as gram-positive&#xD;
        and gram-negative or fungal agents. Infection with the resistant microorganism will be&#xD;
        compared with the control group. Catheter colonization; be defined as bacterial growth of&#xD;
        more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative&#xD;
        culture of the catheter segment or hub without clinical symptoms.&#xD;
  &#xD;
        Patients in both groups with a central catheter for longer than 48 hours will be treated with&#xD;
        a standard bath every 72 hours. In addition to the control group, patients in the study group&#xD;
        will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups&#xD;
        will be compared in terms of catheter-related bloodstream infections and catheter&#xD;
        colonization.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Catheter-related blood stream infection rates</measure>
      <time_frame>2 years.</time_frame>
      <description>In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to CDC diagnostic criteria.&#xD;
  Microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. Infection with the resistant microorganism will be compared with the control group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Catheter colonization rates</measure>
      <time_frame>2 years.</time_frame>
      <description>Catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Demographic features of participants</measure>
      <time_frame>2 years.</time_frame>
      <description>The investigators will be evaluating the features below:&#xD;
  Age of the patients (months)&#xD;
  Sex of patients&#xD;
  Weight of patients (kilograms)&#xD;
  Height of patiens (centimeters)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comorbidities of participants</measure>
      <time_frame>2 years.</time_frame>
      <description>The investigators will be evaluating the comorbidities in each groups, in order to determine if any of these conditions would interfere with infection rates.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Catheter site of placement</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be classified as; femoral, internal jugular, subclavian.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The duration of intensive care unit stay for each participants</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be evaluated as days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of catheter usage</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be evaluated as the total amount of time as days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of catheter lumens</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be evaluated wether it has 2 or 3 lumens.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time when catheter is started the use</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be noted that the time of intensive care hospitalization that catheter usage started.&#xD;
  It will be evaluated as days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of catheter dressing changes</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be evaluated that the amount of planned or unplanned changes of catheter dressing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reason for the catheter removal</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be classified as for example; infection, dysfunction, lack of need...</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The reason of intensive care hospitalization for each participants</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be evaluated that the primary reason that cause for patient to need for intensive care.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PRISM (pediatric risk of mortality) score of the participants</measure>
      <time_frame>2 years.</time_frame>
      <description>The Pediatric Risk of Mortality (PRISM) score was developed from the Physiologic Stability Index (PSI) to reduce the number of physiologic variables required for pediatric ICU (PICU) mortality risk assessment and to obtain an objective weighting of the remaining variables.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Need for invasive mechanical ventilation support</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be evaluated if the patient needed for invasive mechanical ventilation support or not. If so, how many days is it required will be noted.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Need for hemodialysis catheter usage</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be noted that wether the patient has hemodialysis catheter or not.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presence of parenteral steroid use</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be noted that if during the intensive unit care, wether patient need pulse steroid treatment (30milligram/kilogram/day for 3 or more days) or treatment with Prednisolone 2 milligram/kilogram/day or more for 14 or more days</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.</measure>
      <time_frame>Through study completion, 2 years.</time_frame>
      <description>Incidence will be determined by dividing the number of patients who had catheter-related bloodstream infections in patients who underwent daily skin cleansing with chlorhexidine, compared to the total number of patients who underwent daily skin cleansing with chlorhexidine.&#xD;
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.</measure>
      <time_frame>2 years.</time_frame>
      <description>Incidence will be determined by dividing the number of patients who had catheter colonization in patients who underwent daily skin cleansing with chlorhexidine, compared to the total number of patients who underwent daily skin cleansing with chlorhexidine.&#xD;
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.</measure>
      <time_frame>2 years.</time_frame>
      <description>It will be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.</measure>
      <time_frame>2 years.</time_frame>
      <description>It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of catheter-related bloodstream infection in patients who applied standard bathing</measure>
      <time_frame>2 years</time_frame>
      <description>Incidence will be determined by dividing the number of patients who had catheter-related bloodstream infection in patients who underwent standard bathing to the total number of patients who underwent standard bathing.&#xD;
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of catheter colonizsation in patients who applied standard bathing</measure>
      <time_frame>2 years</time_frame>
      <description>Incidence will be determined by dividing the number of patients who had catheter colonization in patients who underwent standard bathing to the total number of patients who underwent standard bathing.&#xD;
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing</measure>
      <time_frame>2 years.</time_frame>
      <description>It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microorganisms that cause catheter colonization in patients which applied standard bathing</measure>
      <time_frame>2 years.</time_frame>
      <description>It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Central Venous Catheter Related Bloodstream Infection</condition>
    <condition>Catheter-Related Infections</condition>
    <condition>Bloodstream Infection Due to Central Venous Catheter</condition>
    <arm_group>
      <arm_group_label>chlorhexidine bathing group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients aged between 2 months and 18 years with temporary central venous catheter in the pediatric intensive care unit were recruited. Patients younger than 2 months of age, patients with a catheter use of less than 48 hours, patients with a history of allergic reaction with chlorhexidine, patients with a skin condition that interferes with skin cleansing with chlorhexidine, and immunocompromised patients were excluded from the study. Participants of the study were randomized with a ratio of 1:1. In study group, standard bathing will be applied on the first day of insertion of the central venous catheter, and in addition to that it is planned to clean the skin of the patient daily with cleaning pads impregnated with 2% Chlorhexidine gluconate.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>standart bathing group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every 72 hours in our facility.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>clorhexidine gluconate bathing</intervention_name>
      <description>daily skin cleansing with chlorhexidine gluconate</description>
      <arm_group_label>chlorhexidine bathing group</arm_group_label>
      <other_name>cathater care practices</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between the ages of 2 months and 18 years who had a temporary central venous&#xD;
               catheter&#xD;
  &#xD;
            -  Patients whose follow-up is continued for at least 48 hours with a central venous&#xD;
               catheter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients younger than 2 months of age&#xD;
  &#xD;
            -  Patients with a intensive care unit stay shorter than 48 hours&#xD;
  &#xD;
            -  Immunosuppressive patients&#xD;
  &#xD;
            -  Patients with a history of allergic reaction to chlorhexidine&#xD;
  &#xD;
            -  Patients with skin lesions that interfere with skin cleansing with chlorhexidine&#xD;
  &#xD;
            -  Patients whose family did not give consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Months</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>IMU</name>
        <address>
          <city>Istanbul</city>
          <state>Kadıköy</state>
          <zip>34800</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>saime hacer özdemir</last_name>
        <phone>+905303862364</phone>
        <email>ozdemirshacer@gmail.com</email>
      </contact>
      <investigator>
        <last_name>muhterem duyu</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Zerr DM, Milstone AM, Dvorak CC, Adler AL, Chen L, Villaluna D, Dang H, Qin X, Addetia A, Yu LC, Conway Keller M, Esbenshade AJ, August KJ, Fisher BT, Sung L. Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group. Cancer. 2021 Jan 1;127(1):56-66. doi: 10.1002/cncr.33271. Epub 2020 Oct 20.</citation>
      <PMID>33079403</PMID>
    </results_reference>
    <results_reference>
      <citation>Tien KL, Sheng WH, Shieh SC, Hung YP, Tien HF, Chen YH, Chien LJ, Wang JT, Fang CT, Chen YC. Chlorhexidine Bathing to Prevent Central Line-Associated Bloodstream Infections in Hematology Units: A Prospective, Controlled Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):556-563. doi: 10.1093/cid/ciz874.</citation>
      <PMID>31504341</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
      <investigator_full_name>Saime Hacer Ozdemir</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <keyword>chlorhexidine gluconate</keyword>
    <keyword>catheter-related bloodstream infections</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>Sepsis</mesh_term>
      <mesh_term>Catheter-Related 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>
  
  
text: 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/NCT05995080
  org study id: 0009-0009-3168-4445
  nct id: NCT05995080
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Catheter-related bloodstream infections are associated with increased mortality, morbidity,
        and length of hospital stay. The incidence has decreased significantly with the strict
        implementation of preventive bundle cares and checklists in intensive care units. Bathing
        with solutions containing chlorhexidine has been included in preventive strategies in recent
        years. Although some studies have shown that chlorhexidine bathing reduces the frequency of
        hospital-associated infections, there are important differences in management of practice and
        adherence to practice in different facilities. The majority of the studies conducted include
        adult patients. According to the CDC guidelines, chlorhexidine bathing is recommended for
        children over 2 months of age to prevent catheter-related bloodstream infection. The aim of
        this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate
        solution in preventing catheter-related bloodstream infections in pediatric patients with
        temporary central venous catheters.
  In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream
        infection will be recorded as laboratory-confirmed bloodstream infections according to CDC
        diagnostic criteria. Microorganisms detected in cultures will be classified as gram-positive
        and gram-negative or fungal agents. Infection with the resistant microorganism will be
        compared with the control group. Catheter colonization; be defined as bacterial growth of
        more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative
        culture of the catheter segment or hub without clinical symptoms.
  
        Patients in both groups with a central catheter for longer than 48 hours will be treated with
        a standard bath every 72 hours. In addition to the control group, patients in the study group
        will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups
        will be compared in terms of catheter-related bloodstream infections and catheter
        colonization.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.
  primary purpose: Prevention
  masking: Single (Investigator)
  masking description: The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.
  measure: Catheter-related blood stream infection rates
  time frame: 2 years.
  description: In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to CDC diagnostic criteria.
  Microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. Infection with the resistant microorganism will be compared with the control group.
  measure: Catheter colonization rates
  time frame: 2 years.
  description: Catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms.
  measure: Demographic features of participants
  time frame: 2 years.
  description: The investigators will be evaluating the features below:
  Age of the patients (months)
  Sex of patients
  Weight of patients (kilograms)
  Height of patiens (centimeters)
  measure: Comorbidities of participants
  time frame: 2 years.
  description: The investigators will be evaluating the comorbidities in each groups, in order to determine if any of these conditions would interfere with infection rates.
  measure: Catheter site of placement
  time frame: 2 years.
  description: It will be classified as; femoral, internal jugular, subclavian.
  measure: The duration of intensive care unit stay for each participants
  time frame: 2 years.
  description: It will be evaluated as days.
  measure: Duration of catheter usage
  time frame: 2 years.
  description: It will be evaluated as the total amount of time as days.
  measure: Number of catheter lumens
  time frame: 2 years.
  description: It will be evaluated wether it has 2 or 3 lumens.
  measure: Time when catheter is started the use
  time frame: 2 years.
  description: It will be noted that the time of intensive care hospitalization that catheter usage started.
  It will be evaluated as days.
  measure: Number of catheter dressing changes
  time frame: 2 years.
  description: It will be evaluated that the amount of planned or unplanned changes of catheter dressing.
  measure: Reason for the catheter removal
  time frame: 2 years.
  description: It will be classified as for example; infection, dysfunction, lack of need...
  measure: The reason of intensive care hospitalization for each participants
  time frame: 2 years.
  description: It will be evaluated that the primary reason that cause for patient to need for intensive care.
  measure: PRISM (pediatric risk of mortality) score of the participants
  time frame: 2 years.
  description: The Pediatric Risk of Mortality (PRISM) score was developed from the Physiologic Stability Index (PSI) to reduce the number of physiologic variables required for pediatric ICU (PICU) mortality risk assessment and to obtain an objective weighting of the remaining variables.
  measure: Need for invasive mechanical ventilation support
  time frame: 2 years.
  description: It will be evaluated if the patient needed for invasive mechanical ventilation support or not. If so, how many days is it required will be noted.
  measure: Need for hemodialysis catheter usage
  time frame: 2 years.
  description: It will be noted that wether the patient has hemodialysis catheter or not.
  measure: Presence of parenteral steroid use
  time frame: 2 years.
  description: It will be noted that if during the intensive unit care, wether patient need pulse steroid treatment (30milligram/kilogram/day for 3 or more days) or treatment with Prednisolone 2 milligram/kilogram/day or more for 14 or more days
  measure: Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.
  time frame: Through study completion, 2 years.
  description: Incidence will be determined by dividing the number of patients who had catheter-related bloodstream infections in patients who underwent daily skin cleansing with chlorhexidine, compared to the total number of patients who underwent daily skin cleansing with chlorhexidine.
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.
  measure: Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.
  time frame: 2 years.
  description: Incidence will be determined by dividing the number of patients who had catheter colonization in patients who underwent daily skin cleansing with chlorhexidine, compared to the total number of patients who underwent daily skin cleansing with chlorhexidine.
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.
  measure: Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.
  time frame: 2 years.
  description: It will be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.
  measure: Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.
  time frame: 2 years.
  description: It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.
  measure: Rate of catheter-related bloodstream infection in patients who applied standard bathing
  time frame: 2 years
  description: Incidence will be determined by dividing the number of patients who had catheter-related bloodstream infection in patients who underwent standard bathing to the total number of patients who underwent standard bathing.
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.
  measure: Rate of catheter colonizsation in patients who applied standard bathing
  time frame: 2 years
  description: Incidence will be determined by dividing the number of patients who had catheter colonization in patients who underwent standard bathing to the total number of patients who underwent standard bathing.
  Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.
  measure: Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing
  time frame: 2 years.
  description: It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.
  measure: Microorganisms that cause catheter colonization in patients which applied standard bathing
  time frame: 2 years.
  description: It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.
  arm group label: chlorhexidine bathing group
  arm group type: Experimental
  description: Patients aged between 2 months and 18 years with temporary central venous catheter in the pediatric intensive care unit were recruited. Patients younger than 2 months of age, patients with a catheter use of less than 48 hours, patients with a history of allergic reaction with chlorhexidine, patients with a skin condition that interferes with skin cleansing with chlorhexidine, and immunocompromised patients were excluded from the study. Participants of the study were randomized with a ratio of 1:1. In study group, standard bathing will be applied on the first day of insertion of the central venous catheter, and in addition to that it is planned to clean the skin of the patient daily with cleaning pads impregnated with 2% Chlorhexidine gluconate.
  arm group label: standart bathing group
  arm group type: No Intervention
  description: Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every 72 hours in our facility.
  intervention type: Other
  intervention name: clorhexidine gluconate bathing
  description: daily skin cleansing with chlorhexidine gluconate
  arm group label: chlorhexidine bathing group
  other name: cathater care practices
  criteria: 
  gender: All
  minimum age: 2 Months
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Turkey
  citation: Zerr DM, Milstone AM, Dvorak CC, Adler AL, Chen L, Villaluna D, Dang H, Qin X, Addetia A, Yu LC, Conway Keller M, Esbenshade AJ, August KJ, Fisher BT, Sung L. Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group. Cancer. 2021 Jan 1;127(1):56-66. doi: 10.1002/cncr.33271. Epub 2020 Oct 20.
  PMID: 33079403
  citation: Tien KL, Sheng WH, Shieh SC, Hung YP, Tien HF, Chen YH, Chien LJ, Wang JT, Fang CT, Chen YC. Chlorhexidine Bathing to Prevent Central Line-Associated Bloodstream Infections in Hematology Units: A Prospective, Controlled Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):556-563. doi: 10.1093/cid/ciz874.
  PMID: 31504341
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medeniyet University
  investigator full name: Saime Hacer Ozdemir
  investigator title: Principle Investigator
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Sepsis
  mesh term: Catheter-Related Infections
  sharing ipd: No