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

Overview

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

Full Title of Study: “Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2011

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.

Interventions

  • Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
    • dressings on catheters

Arms, Groups and Cohorts

  • Active Comparator: Tegaderm HP
  • Placebo Comparator: Tegaderm
  • Active Comparator: Tegaderm CHG

Clinical Trial Outcome Measures

Primary Measures

  • Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
    • Time Frame: 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 Measures

  • dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
    • Time Frame: until catheter removal or ICU discharge (8 days on average)
  • Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost
    • Time Frame: 48 hours after catheter removal or ICU discharge (10 days on average)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • TIMSIT Jean-François, PU/PH, Principal Investigator, Unit Intensive care

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