Comparison of Two New Generations Dressings in Intensive Care Unit (Advanced)

January 20, 2014 updated by: University Hospital, Grenoble

Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units

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 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

Study Type

Observational

Enrollment (Actual)

685

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
    • Isère
      • Grenoble, Isère, France, 38043
        • University Hospital of Grenoble, Medical Intensive Care Unit

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients hospitalised in the Medical ICU and requiring an intravascular device during hospitalisation (peripheral or central)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Tegaderm HP
Patients whose intravasculare devices dressings are made exclusevely with Tegaderm HP dressings.
Advanced
Patients whose intravasculare devices dressings are made exclusevely with Advanced dressings

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 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.
Cost 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)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ADVANCED

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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