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Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients (CLEAN)

Primary Purpose

Preventing Catheter Related Infection

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
skin disinfection prior catheter insertion
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preventing Catheter Related Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 18 year-old
  • Expected duration of ICU stay ≥ 48 hours
  • Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.

Exclusion Criteria:

  • Patient with history of allergy to any of the antiseptic agent studied
  • Expected survival < 48 hours
  • Catheter inserted outside the ICU or in emergency without respect of preventive measures.
  • Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.
  • Pregnant woman or breast-feeding mother

Sites / Locations

  • Angers University Hospital
  • Estain University Hospital
  • Bichat-Claude Bernard Hospital
  • Lyon University Hospital
  • Poitiers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

PVI paint

PVI scrub and paint

Chlorhexidine paint

chlorhexidine scrub and paint

Arm Description

5% alcoholic povidone iodine paint

detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint

2% alcoholic chlorhexidine paint

Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint

Outcomes

Primary Outcome Measures

Major catheter related infection

Secondary Outcome Measures

Catheter colonization
Catheter related bacteremia
Colonization insertion site
Prolongation hospitalization due to catheter infection
Mortality due to catheter infection
Skin allergy and anaphylactic shock
Costs

Full Information

First Posted
June 20, 2012
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01629550
Brief Title
Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients
Acronym
CLEAN
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

Brief Summary
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections. This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventing Catheter Related Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (false)

8. Arms, Groups, and Interventions

Arm Title
PVI paint
Arm Type
Active Comparator
Arm Description
5% alcoholic povidone iodine paint
Arm Title
PVI scrub and paint
Arm Type
Active Comparator
Arm Description
detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint
Arm Title
Chlorhexidine paint
Arm Type
Active Comparator
Arm Description
2% alcoholic chlorhexidine paint
Arm Title
chlorhexidine scrub and paint
Arm Type
Active Comparator
Arm Description
Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint
Intervention Type
Procedure
Intervention Name(s)
skin disinfection prior catheter insertion
Primary Outcome Measure Information:
Title
Major catheter related infection
Secondary Outcome Measure Information:
Title
Catheter colonization
Title
Catheter related bacteremia
Title
Colonization insertion site
Title
Prolongation hospitalization due to catheter infection
Title
Mortality due to catheter infection
Title
Skin allergy and anaphylactic shock
Title
Costs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 year-old Expected duration of ICU stay ≥ 48 hours Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis. Exclusion Criteria: Patient with history of allergy to any of the antiseptic agent studied Expected survival < 48 hours Catheter inserted outside the ICU or in emergency without respect of preventive measures. Use of antimicrobial impregnated catheters or antiseptic impregnated dressings. Pregnant woman or breast-feeding mother
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Estain University Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Bichat-Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Lyon University Hospital
City
Pierre Benite
ZIP/Postal Code
69465
Country
France
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35799302
Citation
Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
Results Reference
derived
PubMed Identifier
32643100
Citation
Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.
Results Reference
derived
PubMed Identifier
29799871
Citation
Maunoury F, Farinetto C, Ruckly S, Guenezan J, Lucet JC, Lepape A, Pascal J, Souweine B, Mimoz O, Timsit JF. Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France. PLoS One. 2018 May 25;13(5):e0197747. doi: 10.1371/journal.pone.0197747. eCollection 2018.
Results Reference
derived
PubMed Identifier
26388532
Citation
Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.
Results Reference
derived
PubMed Identifier
23782845
Citation
Goudet V, Timsit JF, Lucet JC, Lepape A, Balayn D, Seguin S, Mimoz O. Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial. Trials. 2013 Apr 27;14:114. doi: 10.1186/1745-6215-14-114.
Results Reference
derived

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Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients

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