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

Phase 4

Completed

• Conditions: Preventing Catheter Related Infection
• Interventions: Procedure: skin disinfection prior catheter insertion

• Registration Number: NCT01629550
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Study Start: 2012-10
• Status Verified: 2014-03
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI paint	skin disinfection prior catheter insertion	5% alcoholic povidone iodine paint
PVI scrub and paint	skin disinfection prior catheter insertion	detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint
Chlorhexidine paint	skin disinfection prior catheter insertion	2% alcoholic chlorhexidine paint
chlorhexidine scrub and paint	skin disinfection prior catheter insertion	Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint

Primary Outcome Measures

Name	Time	Method
Major catheter related infection

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Angers University Hospital; 🇫🇷 Angers, France

Lyon University Hospital; 🇫🇷 Pierre Benite, France

Bichat-Claude Bernard Hospital; 🇫🇷 Paris, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Estain University Hospital; 🇫🇷 Clermont-Ferrand, France