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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01629550
First received: June 20, 2012
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Preventing Catheter Related Infection
Procedure: skin disinfection prior catheter insertion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Major catheter related infection [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Catheter colonization [ Designated as safety issue: No ]
  • Catheter related bacteremia [ Designated as safety issue: No ]
  • Colonization insertion site [ Designated as safety issue: No ]
  • Prolongation hospitalization due to catheter infection [ Designated as safety issue: No ]
  • Mortality due to catheter infection [ Designated as safety issue: No ]
  • Skin allergy and anaphylactic shock [ Designated as safety issue: Yes ]
  • Costs [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: October 2012
Arms Assigned Interventions
Active Comparator: PVI paint
5% alcoholic povidone iodine paint
Procedure: skin disinfection prior catheter insertion
Active Comparator: PVI scrub and paint
detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint
Procedure: skin disinfection prior catheter insertion
Active Comparator: Chlorhexidine paint
2% alcoholic chlorhexidine paint
Procedure: skin disinfection prior catheter insertion
Active Comparator: chlorhexidine scrub and paint
Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint
Procedure: skin disinfection prior catheter insertion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629550

Locations
France
Angers University Hospital
Angers, France, 49933
Estain University Hospital
Clermont-Ferrand, France, 63000
Bichat-Claude Bernard Hospital
Paris, France, 75018
Lyon University Hospital
Pierre Benite, France, 69465
Poitiers University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided by Poitiers University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01629550     History of Changes
Other Study ID Numbers: 2012-A00090-43
Study First Received: June 20, 2012
Last Updated: March 7, 2014
Health Authority: France: ANSM - Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Catheter-Related Infections
Communicable Diseases
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014