Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection - Full Text View

Sponsored by:	Poitiers University Hospital
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00259350

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 IV

Drug Information available for: Iodine Cadexomer iodine Chlorhexidine Chlorhexidine digluconate Povidone-iodine Ethanol Povidone Benzalkonium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
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

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

Locations

France, Vienne
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 indexed to this study:

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.

Study ID Numbers:	Anticath
Study First Received:	November 27, 2005
Last Updated:	December 5, 2006
ClinicalTrials.gov Identifier:	NCT00259350
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Poitiers University Hospital:

Central venous catheter
Skin disinfection
Antisepsis
Nosocomial infection
Catheter infection

Study placed in the following topic categories:

Chlorhexidine
Chlorhexidine gluconate
Povidone

Iodine
Povidone-Iodine
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009