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Completed

NCT Number: NCT01773564

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

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.

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Key information

Conditions

Complication of Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Grenoble

Grenoble, 38043, France

About this study

randomized controlled trial of 2 intravascular dressings in Intensive care unit

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Current hospital dressing

Device

Patients were assigned to either arm following a randomization scheme 1:1.

Other names: 3M™ HP Dressing or Smith & Nephew IV3000 ™

3M™ IV Advanced Securement dressing

Device

Patients were assigned to either arm following a randomization scheme 1:1.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.

Acronym: ADVANCED

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Jun 15, 2016

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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