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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

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.

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Detailed Description

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Conditions

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Preventing Catheter Related Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PVI paint

5% alcoholic povidone iodine paint

Group Type ACTIVE_COMPARATOR

skin disinfection prior catheter insertion

Intervention Type PROCEDURE

PVI scrub and paint

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

Group Type ACTIVE_COMPARATOR

skin disinfection prior catheter insertion

Intervention Type PROCEDURE

Chlorhexidine paint

2% alcoholic chlorhexidine paint

Group Type ACTIVE_COMPARATOR

skin disinfection prior catheter insertion

Intervention Type PROCEDURE

chlorhexidine scrub and paint

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

Group Type ACTIVE_COMPARATOR

skin disinfection prior catheter insertion

Intervention Type PROCEDURE

Interventions

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skin disinfection prior catheter insertion

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No