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Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients (DRESSING)

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ClinicalTrials.gov Identifier: NCT00417235
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Bacteremia Device: Chlorhexidine Sponge (Biopatch TM) Behavioral: 7-day catheter dressing frequency Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dressing: Comparison of 3-day and 7-day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-related Infection in ICU
Study Start Date : January 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 3-days dressing frequency/CHX sponge

Interventions:

Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site

Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Experimental: 7-days dressing frequency/CHX sponge

Interventions:

Behavioural: 7-day catheter dressing frequency Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site

Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 7-day catheter dressing frequency
dressing changes every 7 days versus every classical change every 3 days
No Intervention: 3-days dressing frequency/No CHX sponge
No intervention, classical protocol of dressing frequency every 3-days and no other device
Experimental: 7-days dressing change/No CHX sponge
Interventions:Behavioural: 7-day catheter dressing frequency
Behavioral: 7-day catheter dressing frequency
dressing changes every 7 days versus every classical change every 3 days


Outcome Measures

Primary Outcome Measures :
  1. Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings [ Time Frame: 48 hours ]
  2. Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. catheter related septicemia [ Time Frame: 48 hours ]
  2. cutaneous allergy [ Time Frame: 24 hours ]
  3. cost [ Time Frame: within the 60 days after catheter insertion ]

Eligibility Criteria

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

Inclusion Criteria:

  • patients older than 18 years
  • with at least a central venous catheter or an arterial catheter
  • whatever the first or subsequent CVC in a same patient
  • in any site of insertion (sub-clavian, jugular or femoral)
  • whatever le CVC is tunnelled or not
  • CVC inserted in the study ICU or immediately before by the intensisvist in the emergency unit or in the operative room,
  • CVC inserted under maximal barrier precautions

Exclusion Criteria:

  • pulmonary artery catheter, haemodialysis/haemodiafiltration CVCs
  • known allergy to chlorhexidine
  • CVC not inserted under maximal barrier precautions
  • Expected duration of CVC for less than 48 hours
  • CVC inserted under emergency conditions
Contacts and Locations

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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): NCT00417235


Locations
France
grenoble university hospital (medical ICU and surgical ICU)
Grenoble, France, 38043
Saint Joseph Hospital
Paris, France, 75014
University Hospital Beaujon
Paris, France, 75018
University hospital Bichat Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
University Hospital, Grenoble
Ministry of Health, France
Investigators
Principal Investigator: jean-francois Timsit University Hospital, Grenoble
Study Chair: jean-christophe Lucet, MD University hospital Bichat, Paris, France
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00417235     History of Changes
Other Study ID Numbers: 05PHN01
First Posted: December 29, 2006    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: June 2008

Keywords provided by University Hospital, Grenoble:
catheter related infection
catheter dressing
prevention
Chlorhexidine impregnated dressings
Infection
catheterization

Additional relevant MeSH terms:
Bacteremia
Systemic Inflammatory Response Syndrome
Catheter-Related Infections
Bacterial Infections
Sepsis
Infection
Inflammation
Pathologic Processes
Shock
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents