Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189682
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
2010-05-25
Brief Title:
Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRESSING2
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 HR039 p003 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
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 Description:
Inclusion criteria Patients older than 18 years old with central venous who need a central vein andor an arterial catheter for an expected duration of more than 48 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None