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

Phase 4

Completed

• Conditions: Catheter-Related Infections
• Interventions: Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

• Registration Number: NCT01189682
• Lead Sponsor: University Hospital, Grenoble

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 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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-09
• Last Update Submitted: 2013-10-18
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1960

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tegaderm	Tegaderm, Tegaderm HP, Tegaderm CHG	-
Tegaderm HP	Tegaderm, Tegaderm HP, Tegaderm CHG	-
Tegaderm CHG	Tegaderm, Tegaderm HP, Tegaderm CHG	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm	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	48 hours after catheter removal or ICU discharge (10 days on average)

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France