CClinicalTrials.gg
CompletedNCT00259350Updated Jan 27, 2009

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

A Phase 4 interventional study of Skin disinfection in ICU Patients Requiring a Central Venous Access, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-27.

Sponsored by Poitiers University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • ICU Patients Requiring a Central Venous Access

Browse trials for

Keywords

  • Central venous catheter
  • Skin disinfection
  • Antisepsis
  • Nosocomial infection
  • Catheter infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 520 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Bacteriemic infection not under control
  • extensive cutaneous infection
  • Women with childbearing potential
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
520 participants

Interventions

  • DrugSkin disinfection
06

What researchers measure

Primary outcomes

  1. Prevention of catheter colonization

Secondary outcomes

  1. Prevention of catheter related bacteremia

  2. Prevention of a positive culture of the catheter whaterver the threshold

  3. Local and general tolerance

07

Study locations

1 site
  • University hospital
    Poitiers, Vienne 86021, France
08

References and documents

Publications

  • 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. PubMed 17954800 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00259350
Lead sponsor
Poitiers University Hospital
First posted
Nov 29, 2005
Start date
May 2004
Completion
Apr 2006
Last update
Jan 27, 2009

Study contacts

Olivier MIMOZ, MD, PhD
study chair · University Hospital of Poitiers, france
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion