ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00259350
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : January 27, 2009
Sponsor:
Information provided by:
Poitiers University Hospital

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
ICU Patients Requiring a Central Venous Access Drug: Skin disinfection Phase 4

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevention of catheter colonization

Secondary Outcome Measures :
  1. Prevention of catheter related bacteremia
  2. Prevention of a positive culture of the catheter whaterver the threshold
  3. Local and general tolerance

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

ClinicalTrials.gov Identifier: NCT00259350     History of Changes
Other Study ID Numbers: Anticath
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

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