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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:

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
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
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

No publications provided by Poitiers University Hospital

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

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:
Povidone
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013