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

Overview

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.

Full Title of Study: “Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2013

Detailed Description

randomized controlled trial of 2 intravascular dressings in Intensive care unit

Interventions

  • Device: Current hospital dressing
    • Patients were assigned to either arm following a randomization scheme 1:1.
  • Device: 3M™ IV Advanced Securement dressing
    • Patients were assigned to either arm following a randomization scheme 1:1.

Arms, Groups and Cohorts

  • 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 ™
  • Experimental: 3M™ IV Advanced Securement dressing
    • New generation transparent dressing

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Provider of Information About this Clinical Study
    • Sponsor

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