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

Catheter-Related Infections Clinical Trial

— DRESSING2  

Official title:

Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189682
• Other study ID #: 2009-A01184-53
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2010
• Last updated: October 18, 2013
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1960
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-Related Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel	The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.	48 hours after catheter removal or ICU discharge (10 days on average)	No
Secondary	dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm		until catheter removal or ICU discharge (8 days on average)	No
Secondary	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)	No