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Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
This study has been completed.
Sponsor:
Poitiers University Hospital
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00259350
First received: November 27, 2005
Last updated: January 26, 2009
Last verified: January 2009
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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 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) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259350
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):
| ClinicalTrials.gov Identifier: | NCT00259350 History of Changes |
| Other Study ID Numbers: |
Anticath |
| Study First Received: | November 27, 2005 |
| Last Updated: | January 26, 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 |
ClinicalTrials.gov processed this record on July 19, 2017