Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment (DRESSING2)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Catheter-Related Infections

Treatments: Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

Study type: Interventional

Funder types: Other

Identifiers

NCT01189682

2009-A01184-53

Details and patient eligibility

About

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 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.

Enrollment: 1,960 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,960 participants in 3 patient groups, including a placebo group

Tegaderm HP

Active Comparator group

Treatment:

Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

Tegaderm

Placebo Comparator group

Treatment:

Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

Tegaderm CHG

Active Comparator group

Treatment:

Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG