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Completed

NCT Number: NCT01189682

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

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

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Key information

Conditions

Catheter-Related Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Grenoble

Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegaderm, Tegaderm HP, Tegaderm CHG

Procedure

dressings on catheters

Other names: Tegaderm, Tegaderm HP, tegaderm CHG

Primary outcomes

  1. Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel

    Time frame: 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 outcomes

  1. dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm

    Time frame: until catheter removal or ICU discharge (8 days on average)

  2. Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost

    Time frame: 48 hours after catheter removal or ICU discharge (10 days on average)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: DRESSING2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 27, 2010
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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