Skip to content

Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01629550
Acronym
CLEAN
Enrollment
2400
Registered
2012-06-27
Start date
2012-10-31
Completion date
Unknown
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventing Catheter Related Infection

Brief summary

Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections. This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.

Interventions

PROCEDUREskin disinfection prior catheter insertion

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 18 year-old * Expected duration of ICU stay ≥ 48 hours * Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.

Exclusion criteria

* Patient with history of allergy to any of the antiseptic agent studied * Expected survival \< 48 hours * Catheter inserted outside the ICU or in emergency without respect of preventive measures. * Use of antimicrobial impregnated catheters or antiseptic impregnated dressings. * Pregnant woman or breast-feeding mother

Design outcomes

Primary

MeasureTime frame
Major catheter related infection

Secondary

MeasureTime frame
Catheter related bacteremia
Colonization insertion site
Prolongation hospitalization due to catheter infection
Catheter colonization
Skin allergy and anaphylactic shock
Costs
Mortality due to catheter infection

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026