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

June 14, 2016 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

randomized controlled trial of 2 intravascular dressings in Intensive care unit

Study Type

Interventional

Enrollment (Actual)

628

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
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.
From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
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.
From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12SC03
  • 2012-A00734-39 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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