Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection

This study has been completed.

Sponsor:

Information provided by:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT00259350

First received: November 27, 2005

Last updated: January 26, 2009

Last verified: January 2009

History of Changes

Purpose

The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.

To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.

To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations

Condition	Intervention	Phase
ICU Patients Requiring a Central Venous Access	Drug: Skin disinfection	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol

Resource links provided by NLM:

MedlinePlus related topics: Germs and Hygiene

Drug Information available for: Chlorhexidine Chlorhexidine acetate Chlorhexidine hydrochloride Iodine Povidone Chlorhexidine gluconate Povidone-iodine Hibiclens

U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:

Prevention of catheter colonization

Secondary Outcome Measures:

Prevention of catheter related bacteremia
Prevention of a positive culture of the catheter whaterver the threshold
Local and general tolerance


Estimated Enrollment:	520
Study Start Date:	May 2004
Estimated Study Completion Date:	April 2006

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients over 18 yeras of age
Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h
Informed consent signed up

Exclusion Criteria:

Bacteriemic infection not under control
extensive cutaneous infection
Women with childbearing potential

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259350

Locations


France
University hospital
Poitiers, Vienne, France, 86021

Sponsors and Collaborators

Poitiers University Hospital

Investigators


Study Chair:	Olivier MIMOZ, MD, PhD	University Hospital of Poitiers, france

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B. Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med. 2007 Oct 22;167(19):2066-72.


ClinicalTrials.gov Identifier:	NCT00259350 History of Changes
Other Study ID Numbers:	Anticath
Study First Received:	November 27, 2005
Last Updated:	January 26, 2009
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Poitiers University Hospital:


Central venous catheter Skin disinfection Antisepsis Nosocomial infection Catheter infection

Additional relevant MeSH terms:


Infection Chlorhexidine Chlorhexidine gluconate Povidone-Iodine Povidone Anti-Infective Agents, Local	Anti-Infective Agents Disinfectants Dermatologic Agents Plasma Substitutes Blood Substitutes

ClinicalTrials.gov processed this record on September 27, 2016

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