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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01629550
First received: June 20, 2012
Last updated: March 7, 2014
Last verified: March 2014

June 20, 2012
March 7, 2014
October 2012
Not Provided
Major catheter related infection [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01629550 on ClinicalTrials.gov Archive Site
  • Catheter colonization [ Designated as safety issue: No ]
  • Catheter related bacteremia [ Designated as safety issue: No ]
  • Colonization insertion site [ Designated as safety issue: No ]
  • Prolongation hospitalization due to catheter infection [ Designated as safety issue: No ]
  • Mortality due to catheter infection [ Designated as safety issue: No ]
  • Skin allergy and anaphylactic shock [ Designated as safety issue: Yes ]
  • Costs [ Designated as safety issue: No ]
  • Catheter colonization [ Designated as safety issue: No ]
  • Catheter related bacteremia [ Designated as safety issue: No ]
  • Colonization insertion site [ Designated as safety issue: No ]
  • Prolongation hospitalization due to catheter infection [ Designated as safety issue: No ]
  • Motality due to catheter infection [ Designated as safety issue: No ]
  • Skin allergy and anaphylactic shock [ Designated as safety issue: Yes ]
  • Costs [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Preventing Catheter Related Infection
Procedure: skin disinfection prior catheter insertion
  • Active Comparator: PVI paint
    5% alcoholic povidone iodine paint
    Intervention: Procedure: skin disinfection prior catheter insertion
  • Active Comparator: PVI scrub and paint
    detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint
    Intervention: Procedure: skin disinfection prior catheter insertion
  • Active Comparator: Chlorhexidine paint
    2% alcoholic chlorhexidine paint
    Intervention: Procedure: skin disinfection prior catheter insertion
  • Active Comparator: chlorhexidine scrub and paint
    Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint
    Intervention: Procedure: skin disinfection prior catheter insertion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2400
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01629550
2012-A00090-43
Not Provided
Poitiers University Hospital
Poitiers University Hospital
Not Provided
Not Provided
Poitiers University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP