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Clinical Trials/NCT01629550
NCT01629550
Completed
Phase 4

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

Poitiers University Hospital5 sites in 1 country2,400 target enrollmentOctober 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Preventing Catheter Related Infection
Sponsor
Poitiers University Hospital
Enrollment
2400
Locations
5
Primary Endpoint
Major catheter related infection
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Major catheter related infection

Secondary Outcomes

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

Study Sites (5)

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