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

Study Overview
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Brief Summary
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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.

Conditions
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Preventing Catheter Related Infection

Intervention / Treatment
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* Procedure: skin disinfection prior catheter insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI paint<br>5% alcoholic povidone iodine paint | Procedure: skin disinfection prior catheter insertion<br> <br> |
| Active Comparator: PVI scrub and paint<br>detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint | Procedure: skin disinfection prior catheter insertion<br> <br> |
| Active Comparator: Chlorhexidine paint<br>2% alcoholic chlorhexidine paint | Procedure: skin disinfection prior catheter insertion<br> <br> |
| Active Comparator: chlorhexidine scrub and paint<br>Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint | Procedure: skin disinfection prior catheter insertion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major catheter related infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |