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

Poitiers University Hospital

Status and phase: Completed; Phase 4

Conditions: Preventing Catheter Related Infection

Treatments: Procedure: skin disinfection prior catheter insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT01629550

CLEAN

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 4 patient groups

PVI paint

Active Comparator group

Description:

5% alcoholic povidone iodine paint

Treatment:

Procedure: skin disinfection prior catheter insertion

PVI scrub and paint

Active Comparator group

Description:

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

Treatment:

Procedure: skin disinfection prior catheter insertion

Chlorhexidine paint

Active Comparator group

Description:

2% alcoholic chlorhexidine paint

Treatment:

Procedure: skin disinfection prior catheter insertion

chlorhexidine scrub and paint

Active Comparator group

Description:

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

Treatment:

Procedure: skin disinfection prior catheter insertion