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Sponsored by: |
Poitiers University Hospital |
Information provided by: | Poitiers University Hospital |
ClinicalTrials.gov Identifier: | NCT00259350 |
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 |
ChemIDplus related topics: | Iodine Cadexomer iodine Chlorhexidine Chlorhexidine digluconate Povidone-iodine Ethanol Povidone Benzalkonium chloride |
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 |
Estimated Enrollment: | 520 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Anticath |
First Received: | November 27, 2005 |
Last Updated: | December 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00259350 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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