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

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ClinicalTrials.gov Identifier: NCT01189682
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Catheter-Related Infections Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
Study Start Date : April 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Active Comparator: Tegaderm HP Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG

Placebo Comparator: Tegaderm Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG

Active Comparator: Tegaderm CHG Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189682


Locations
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France
University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: TIMSIT Jean-François, PU/PH Unit Intensive care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01189682    
Other Study ID Numbers: 2009-A01184-53
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: September 2012
Keywords provided by University Hospital, Grenoble:
catheter
dressing
chlorhexidine
Patient admitted in ICU with a CVC or art. catheter
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Catheter-Related Infections