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

NCT ID: NCT01773564

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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randomized controlled trial of 2 intravascular dressings in Intensive care unit

Conditions

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Complication of Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Available current hospital dressing

Control group: depending on the type of dressing available at the hospital, either 3M™ HP Dressing or Smith \& Nephew IV3000 ™

Group Type ACTIVE_COMPARATOR

Current hospital dressing

Intervention Type DEVICE

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

3M™ IV Advanced Securement dressing

New generation transparent dressing

Group Type EXPERIMENTAL

3M™ IV Advanced Securement dressing

Intervention Type DEVICE

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

Interventions

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Current hospital dressing

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

Intervention Type DEVICE

3M™ IV Advanced Securement dressing

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

Intervention Type DEVICE

Other Intervention Names

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3M™ HP Dressing or Smith & Nephew IV3000 ™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00734-39

Identifier Type: OTHER

Identifier Source: secondary_id

12SC03

Identifier Type: -

Identifier Source: org_study_id

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