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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter-Related Infections

Intervention / Treatment
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* Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tegaderm HP<br> | Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG<br>* dressings on catheters<br>* Other names: tegaderm CHG;|
| Placebo Comparator: Tegaderm<br> | Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG<br>* dressings on catheters<br>* Other names: tegaderm CHG;|
| Active Comparator: Tegaderm CHG<br> | Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG<br>* dressings on catheters<br>* Other names: tegaderm CHG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter, dressing, chlorhexidine, Patient admitted in ICU with a CVC or art. catheter