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OpenTrials
Completed

NCT Number: NCT01629550

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

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.

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Key information

Conditions

Preventing Catheter Related Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Angers University Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skin disinfection prior catheter insertion

Procedure

Primary outcomes

  1. Major catheter related infection

Secondary outcomes

  1. Catheter colonization

  2. Catheter related bacteremia

  3. Colonization insertion site

  4. Prolongation hospitalization due to catheter infection

  5. Mortality due to catheter infection

  6. Skin allergy and anaphylactic shock

  7. Costs

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: CLEAN

Important dates

Study start
2012
First posted
Jun 27, 2012
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.