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

October 10, 2016 updated by: Poitiers University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Angers University Hospital
      • Clermont-Ferrand, France, 63000
        • Estain University Hospital
      • Paris, France, 75018
        • Bichat-Claude Bernard Hospital
      • Pierre Benite, France, 69465
        • Lyon University Hospital
      • Poitiers, France, 86021
        • Poitiers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Major catheter related infection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEAN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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