Back to resultsChlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
Primary Purpose
ICU Patients Requiring a Central Venous Access
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Skin disinfection
Sponsored by
About this trial
This is an interventional treatment trial for ICU Patients Requiring a Central Venous Access focused on measuring Central venous catheter, Skin disinfection, Antisepsis, Nosocomial infection, Catheter infection
Eligibility 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
Sites / Locations
- University hospital
Outcomes
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
Full Information
NCT ID
NCT00259350
First Posted
November 27, 2005
Last Updated
January 26, 2009
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00259350
Brief Title
Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Patients Requiring a Central Venous Access
Keywords
Central venous catheter, Skin disinfection, Antisepsis, Nosocomial infection, Catheter infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Skin disinfection
Primary Outcome Measure Information:
Title
Prevention of catheter colonization
Secondary Outcome Measure Information:
Title
Prevention of catheter related bacteremia
Title
Prevention of a positive culture of the catheter whaterver the threshold
Title
Local and general tolerance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier MIMOZ, MD, PhD
Organizational Affiliation
University Hospital of Poitiers, france
Official's Role
Study Chair
Facility Information:
Facility Name
University hospital
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17954800
Citation
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. doi: 10.1001/archinte.167.19.2066.
Results Reference
derived
Learn more about this trial
Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
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