Clinical Trial: Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
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
Detailed Summary: 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.
Sponsor: University Hospital, Grenoble
Current Primary Outcome: 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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) ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Grenoble
Dates:
Date Received: May 25, 2010
Date Started: April 2010
Date Completion:
Last Updated: October 18, 2013
Last Verified: September 2012