<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/NCT03757143</url>
  </required_header>
  <id_info>
    <org_study_id>CLEAN3</org_study_id>
    <nct_id>NCT03757143</nct_id>
  </id_info>
  <brief_title>Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure</brief_title>
  <acronym>CLEAN3</acronym>
  <official_title>Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure: An Open Label, Single Center, Randomized Controlled, Two-by-two Factorial Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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>
      Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical&#xD;
      devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the&#xD;
      occurrence of complications, which can be mechanical, vascular or infectious. Complications&#xD;
      lead to infusion failure and device replacement, which results in interrupted therapy, pain&#xD;
      associated with resiting and increased health care costs for resources and staff time.&#xD;
      Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase&#xD;
      treatment costs and mortality.&#xD;
&#xD;
      Prevention of these complications is based on the respect of hygiene rules and the use of&#xD;
      bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key.&#xD;
      Similarly, the use of new technologies such as catheters designed to minimize blood exposure,&#xD;
      zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each&#xD;
      medication administration to maintain catheter patency are of theoretical interest, but&#xD;
      little scientific data support their use in routine.&#xD;
&#xD;
      The primary objectives of this study are, first, to demonstrate that skin preparation with 2%&#xD;
      chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin&#xD;
      preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a&#xD;
      bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting&#xD;
      caps, and single-use prefilled flush syringes extends the time between catheter insertion and&#xD;
      catheter failure.&#xD;
&#xD;
      The secondary objectives are to compare between the four study group incidence of phlebitis,&#xD;
      accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection,&#xD;
      all-cause bloodstream infections, catheter colonization, duration of catheter remaining in&#xD;
      place without complication, length of hospital stay, safety and patient satisfaction.&#xD;
&#xD;
      The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised,&#xD;
      four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h&#xD;
      will be randomised in one of four groups according to skin disinfection method and type of&#xD;
      devices used. Randomization will be carried out through a secure web-based randomization&#xD;
      system. Inclusions are expected to begin in January 2019 and continue until July 2019, once&#xD;
      the number of catheters required has been reached.&#xD;
&#xD;
      Patients will be enrolled at the Emergency department of the Poitiers University Hospital&#xD;
      before being hospitalised in one of five wards (neurology, neurology, pneumology, internal&#xD;
      medicine and downstream emergency unit).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">September 27, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of catheter-related infectious complications</measure>
    <time_frame>8 days</time_frame>
    <description>Incidence of catheter-related infectious complications, and include catheter colonisation, local infection and CR-BSI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time between catheter insertion and catheter failure</measure>
    <time_frame>8 days</time_frame>
    <description>Time between catheter insertion and catheter failure: defined as any premature removal of PVC before end of treatment, other than for routine replacement, and includes phlebitis, infiltration, occlusion, accidental catheter removal, local infection and CR-BSI whichever occurred first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of phlebitis</measure>
    <time_frame>8 days</time_frame>
    <description>Number of phlebitis defined as two or more of the following present simultaneously: (1) patient-reported pain or tenderness (on questioning, then palpation by the research nurse) with a severity of two or more on a ten-point scale; (2) erythema extending at least 1 cm from the insertion site; (3) swelling, extending at least 1 cm from the insertion site; (4) purulent discharge; or (5) palpable venous cord beyond the intravenous catheter tip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of accidental catheter removal</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of infiltration</measure>
    <time_frame>8 days</time_frame>
    <description>Number of infiltration, defined as the infusion of non-blistering drug leaking through the normal vascular channel and resulting in the swelling of tissue peripheral to the puncture site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of catheter occlusion</measure>
    <time_frame>8 days</time_frame>
    <description>Number of catheter occlusion defined as the inability of the catheter to flush (not able to intravenously inject 1ml of normal saline within 30 s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of CR-BSI</measure>
    <time_frame>8 days</time_frame>
    <description>Number of CR-BSI, defined as (1) at least one positive blood culture from a peripheral vein and (2) clinical signs of infection (ie, fever [body temperature &gt;38°5], hypothermia [body temperature &lt;36°5], chills, or hypotension [Systolic blood pressure &lt;90 mm Hg]) and (3) no other apparent source for the bloodstream infection except the PVC (in situ within 48 h of the bloodstream infection); and (4) a colonized intravenous catheter tip culture with the same organism (same species) as identified in the blood. For commensal micro-organisms (coagulase-negative staphylococci, Corynebacterium spp. [except C. jeikeium], Lactobacillus spp., Bacillus spp. and Propionibacterium spp., or viridans group Streptococcus isolates and C. perfringens) at least two positive blood cultures will be required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of local infection</measure>
    <time_frame>8 days</time_frame>
    <description>Number of local infection, defined as organisms grown from purulent discharge with no evidence of associated bloodstream infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of all-cause bloodstream infections</measure>
    <time_frame>8 days</time_frame>
    <description>Number of all-cause bloodstream infections, defined as any positive blood culture drawn from a peripheral vein while intravenous catheter in situ or for 48 h after removal. For commensal micro-organisms (coagulase-negative staphylococci, Corynebacterium spp. [except C. jeikeium], Lactobacillus spp., Bacillus spp. and Propionibacterium spp., or viridans group Streptococcus isolates and C. perfringens) at least two positive blood cultures will be required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of catheter colonization</measure>
    <time_frame>8 days</time_frame>
    <description>Number of catheter colonization defined as the culture of intravascular catheter tip showing at least 1000 colony-forming units per ml (cfu/ml).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pathogens involved in catheter colonization, local infections, CR-BSI and all-cause bloodstream infections</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days the catheter remaining in place without complication</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital stay censored at day 28</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of local and systemic side effects possibly linked to antiseptic use</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation of the pain at the insertion of the catheter using visual analogue scale (VAS)</measure>
    <time_frame>8 days</time_frame>
    <description>Visual analogue scale is increased from 0 to 10, 0 is the better outcome (no pain) and 10 is the worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction at catheter removal using visual analogue scale (VAS)</measure>
    <time_frame>8 days</time_frame>
    <description>Visual analogue scale is increased from 0 to 10, 0 is the worse outcome (no satisfaction) and 10 is the better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation impact of venous line on patients' mobility at catheter removal using visual analogue scale</measure>
    <time_frame>8 days</time_frame>
    <description>Visual analogue scale is increased from 0 to 10, 0 is the better outcome (no impact of patients'mobility) and 10 is the worse outcome</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Intravascular-catheter Colonization</condition>
  <condition>Catheter Failure</condition>
  <arm_group>
    <arm_group_label>PVI et Insyte</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Groupe A: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) InsyteTM AutoguardTM BC Winged, BD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHG et Insyte</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groupe B: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) InsyteTM AutoguardTM BC Winged, BD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PVI et Nexiva</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groupe C: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, , PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHG et Nexiva</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Groupe D: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-Iodine-Alcohol</intervention_name>
    <description>Povidone-Iodine-Alcohol will be used to disinfect the skin</description>
    <arm_group_label>PVI et Insyte</arm_group_label>
    <arm_group_label>PVI et Nexiva</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine-Alcohol</intervention_name>
    <description>Chlorhexidine-Alcohol will be used to disinfect the skin</description>
    <arm_group_label>CHG et Insyte</arm_group_label>
    <arm_group_label>CHG et Nexiva</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insyte Autoguard BC Winged</intervention_name>
    <description>Pose of Insyte Autoguard BC Winged</description>
    <arm_group_label>CHG et Insyte</arm_group_label>
    <arm_group_label>PVI et Insyte</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes</intervention_name>
    <description>Pose of Nexiva single port catheter</description>
    <arm_group_label>CHG et Nexiva</arm_group_label>
    <arm_group_label>PVI et Nexiva</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (age ≥ 18 years) patients,&#xD;
&#xD;
          -  Having clinical indication for placement of a single PVC for at least 48 hours (no&#xD;
             minimum port access during the study duration),&#xD;
&#xD;
          -  Willing and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies to CHG, PVI, isopropanol or ethanol,&#xD;
&#xD;
          -  Participation to another clinical trial aimed at reducing PVC complications,&#xD;
&#xD;
          -  Suspicion of bloodstream infection at catheter insertion,&#xD;
&#xD;
          -  Skin injury a catheter insertion site increasing the risk of catheter infection,&#xD;
&#xD;
          -  PVC inserted extremely urgently, making it impossible to comply with the protocol,&#xD;
&#xD;
          -  Intravascular catheter in place within the last 2 days, or within the last 2 weeks and&#xD;
             with local signs of catheter complication,&#xD;
&#xD;
          -  Difficult catheter insertion suspected (obesity, known IV drug users, non-visible&#xD;
             venous network after placement of a tourniquet...),&#xD;
&#xD;
          -  Patients already enrolled in this study,&#xD;
&#xD;
          -  Terminal or moribund patient not expected to live more than one week,&#xD;
&#xD;
          -  Patients not benefiting from a Social Security scheme or not benefiting from it&#xD;
             through a third party,&#xD;
&#xD;
          -  Persons benefiting from enhanced protection, namely minors, persons deprived of their&#xD;
             liberty by a judicial or administrative decision, adults under legal protection.&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Women at age to procreate and not using effective contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin antisepsis</keyword>
  <keyword>Chlorhexidine</keyword>
  <keyword>Povidone Iodine</keyword>
  <keyword>Intravascular-catheter colonization</keyword>
  <keyword>Catheter failure</keyword>
  <keyword>Bundle of new devices</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_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/NCT03757143
org study id: CLEAN3
nct id: NCT03757143
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical
      devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the
      occurrence of complications, which can be mechanical, vascular or infectious. Complications
      lead to infusion failure and device replacement, which results in interrupted therapy, pain
      associated with resiting and increased health care costs for resources and staff time.
      Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase
      treatment costs and mortality.

      Prevention of these complications is based on the respect of hygiene rules and the use of
      bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key.
      Similarly, the use of new technologies such as catheters designed to minimize blood exposure,
      zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each
      medication administration to maintain catheter patency are of theoretical interest, but
      little scientific data support their use in routine.

      The primary objectives of this study are, first, to demonstrate that skin preparation with 2%
      chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin
      preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a
      bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting
      caps, and single-use prefilled flush syringes extends the time between catheter insertion and
      catheter failure.

      The secondary objectives are to compare between the four study group incidence of phlebitis,
      accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection,
      all-cause bloodstream infections, catheter colonization, duration of catheter remaining in
      place without complication, length of hospital stay, safety and patient satisfaction.

      The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised,
      four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h
      will be randomised in one of four groups according to skin disinfection method and type of
      devices used. Randomization will be carried out through a secure web-based randomization
      system. Inclusions are expected to begin in January 2019 and continue until July 2019, once
      the number of catheters required has been reached.

      Patients will be enrolled at the Emergency department of the Poitiers University Hospital
      before being hospitalised in one of five wards (neurology, neurology, pneumology, internal
      medicine and downstream emergency unit).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of catheter-related infectious complications
time frame: 8 days
description: Incidence of catheter-related infectious complications, and include catheter colonisation, local infection and CR-BSI
measure: Time between catheter insertion and catheter failure
time frame: 8 days
description: Time between catheter insertion and catheter failure: defined as any premature removal of PVC before end of treatment, other than for routine replacement, and includes phlebitis, infiltration, occlusion, accidental catheter removal, local infection and CR-BSI whichever occurred first
measure: Number of phlebitis
time frame: 8 days
description: Number of phlebitis defined as two or more of the following present simultaneously: (1) patient-reported pain or tenderness (on questioning, then palpation by the research nurse) with a severity of two or more on a ten-point scale; (2) erythema extending at least 1 cm from the insertion site; (3) swelling, extending at least 1 cm from the insertion site; (4) purulent discharge; or (5) palpable venous cord beyond the intravenous catheter tip
measure: Number of accidental catheter removal
time frame: 8 days
measure: Number of infiltration
time frame: 8 days
description: Number of infiltration, defined as the infusion of non-blistering drug leaking through the normal vascular channel and resulting in the swelling of tissue peripheral to the puncture site
measure: Number of catheter occlusion
time frame: 8 days
description: Number of catheter occlusion defined as the inability of the catheter to flush (not able to intravenously inject 1ml of normal saline within 30 s)
measure: Number of CR-BSI
time frame: 8 days
description: Number of CR-BSI, defined as (1) at least one positive blood culture from a peripheral vein and (2) clinical signs of infection (ie, fever [body temperature >38°5], hypothermia [body temperature <36°5], chills, or hypotension [Systolic blood pressure <90 mm Hg]) and (3) no other apparent source for the bloodstream infection except the PVC (in situ within 48 h of the bloodstream infection); and (4) a colonized intravenous catheter tip culture with the same organism (same species) as identified in the blood. For commensal micro-organisms (coagulase-negative staphylococci, Corynebacterium spp. [except C. jeikeium], Lactobacillus spp., Bacillus spp. and Propionibacterium spp., or viridans group Streptococcus isolates and C. perfringens) at least two positive blood cultures will be required.
measure: Number of local infection
time frame: 8 days
description: Number of local infection, defined as organisms grown from purulent discharge with no evidence of associated bloodstream infection
measure: Number of all-cause bloodstream infections
time frame: 8 days
description: Number of all-cause bloodstream infections, defined as any positive blood culture drawn from a peripheral vein while intravenous catheter in situ or for 48 h after removal. For commensal micro-organisms (coagulase-negative staphylococci, Corynebacterium spp. [except C. jeikeium], Lactobacillus spp., Bacillus spp. and Propionibacterium spp., or viridans group Streptococcus isolates and C. perfringens) at least two positive blood cultures will be required
measure: Number of catheter colonization
time frame: 8 days
description: Number of catheter colonization defined as the culture of intravascular catheter tip showing at least 1000 colony-forming units per ml (cfu/ml).
measure: Number of pathogens involved in catheter colonization, local infections, CR-BSI and all-cause bloodstream infections
time frame: 8 days
measure: Number of days the catheter remaining in place without complication
time frame: 8 days
measure: Length of Hospital stay censored at day 28
time frame: 28 days
measure: Incidence of local and systemic side effects possibly linked to antiseptic use
time frame: 8 days
measure: Patient's evaluation of the pain at the insertion of the catheter using visual analogue scale (VAS)
time frame: 8 days
description: Visual analogue scale is increased from 0 to 10, 0 is the better outcome (no pain) and 10 is the worse outcome
measure: Patient's satisfaction at catheter removal using visual analogue scale (VAS)
time frame: 8 days
description: Visual analogue scale is increased from 0 to 10, 0 is the worse outcome (no satisfaction) and 10 is the better outcome
measure: Evaluation impact of venous line on patients' mobility at catheter removal using visual analogue scale
time frame: 8 days
description: Visual analogue scale is increased from 0 to 10, 0 is the better outcome (no impact of patients'mobility) and 10 is the worse outcome
arm group label: PVI et Insyte
arm group type: Active Comparator
description: Groupe A: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) InsyteTM AutoguardTM BC Winged, BD
arm group label: CHG et Insyte
arm group type: Experimental
description: Groupe B: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) InsyteTM AutoguardTM BC Winged, BD
arm group label: PVI et Nexiva
arm group type: Experimental
description: Groupe C: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, , PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD
arm group label: CHG et Nexiva
arm group type: Experimental
description: Groupe D: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD
intervention type: Drug
intervention name: Povidone-Iodine-Alcohol
description: Povidone-Iodine-Alcohol will be used to disinfect the skin
arm group label: PVI et Insyte
arm group label: PVI et Nexiva
intervention type: Drug
intervention name: Chlorhexidine-Alcohol
description: Chlorhexidine-Alcohol will be used to disinfect the skin
arm group label: CHG et Insyte
arm group label: CHG et Nexiva
intervention type: Device
intervention name: Insyte Autoguard BC Winged
description: Pose of Insyte Autoguard BC Winged
arm group label: CHG et Insyte
arm group label: PVI et Insyte
intervention type: Device
intervention name: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes
description: Pose of Nexiva single port catheter
arm group label: CHG et Nexiva
arm group label: PVI et Nexiva
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Ethanol
mesh term: Chlorhexidine
mesh term: Povidone-Iodine
mesh term: Povidone