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Comparison of Two New Generation Dressings in Intensive Care (ADVANCED) (ADVANCED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01773564
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the investigators goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.

Condition or disease Intervention/treatment
Complication of Catheter Device: Current hospital dressing Device: 3M™ IV Advanced Securement dressing

Detailed Description:
randomized controlled trial of 2 intravascular dressings in Intensive care unit

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.
Study Start Date : October 2012
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Available current hospital dressing
Control group: depending on the type of dressing available at the hospital, either 3M™ HP Dressing or Smith & Nephew IV3000 ™
Device: Current hospital dressing
Patients were assigned to either arm following a randomization scheme 1:1.
Other Name: 3M™ HP Dressing or Smith & Nephew IV3000 ™
Experimental: 3M™ IV Advanced Securement dressing
New generation transparent dressing
Device: 3M™ IV Advanced Securement dressing
Patients were assigned to either arm following a randomization scheme 1:1.


Outcome Measures

Primary Outcome Measures :
  1. Number of catheters presenting any kind of complications.. [ Time Frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks. ]

Secondary Outcome Measures :
  1. Number of catheter infections related to poor adherent dressings. [ Time Frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks ]

Other Outcome Measures:
  1. Number of participants presenting allergic adverse events [ Time Frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks. ]
  2. Costs of each dressing type strategy. [ Time Frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks. ]

Eligibility Criteria

Information from the National Library of Medicine

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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 over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting.
  • Patients benefiting from the social security protection.

Exclusion Criteria:

  • Patients under 18 years of age,
  • Patients having known allergy or sensitivity to adhesive dressing materials
Contacts and Locations

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): NCT01773564


Locations
France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01773564     History of Changes
Other Study ID Numbers: 12SC03
2012-A00734-39 ( Other Identifier: ID RCB )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
Dressings, Prevention,