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DRESSING2: Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT01189682
Collaborator
(none)
1,960
Enrollment
1
Location
3
Arms
15
Duration (Months)
130.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.

Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.

Secondary objectives:

  • To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.

  • To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).

  • To calculate the cost saving of each dressings

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
 Phase 4

Detailed Description

Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.

Study Design

Study Type:
Interventional
Actual Enrollment :
1960 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tegaderm HP

Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG

    		•
    Placebo Comparator: Tegaderm

    Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
    dressings on catheters
    Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG

    		•
    Active Comparator: Tegaderm CHG

    Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
    dressings on catheters
    Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel [48 hours after catheter removal or ICU discharge (10 days on average)]

      The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.

    Secondary Outcome Measures

    1. dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm [until catheter removal or ICU discharge (8 days on average)]

    2. Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost [48 hours after catheter removal or ICU discharge (10 days on average)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours
    Exclusion Criteria:

    • pulmonary arterial catheter

    • antiseptic-impregnated catheter

    • hemodialysis catheter

    • chlorhexidine allergy

    • emergency catheter without surgical asepsis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Grenoble Grenoble France

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    • Principal Investigator: TIMSIT Jean-François, PU/PH, Unit Intensive care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT01189682
    Other Study ID Numbers:
    • 2009-A01184-53
    First Posted:
    Aug 27, 2010
    Last Update Posted:
    Oct 21, 2013
    Last Verified:
    Sep 1, 2012
    Keywords provided by University Hospital, Grenoble
    catheter
    dressing
    chlorhexidine
    Patient admitted in ICU with a CVC or art. catheter
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Catheter-Related Infections

    Study Results

    No Results Posted as of Oct 21, 2013