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

Not Applicable

Completed

• Conditions: Complication of Catheter
• Interventions: Device: Current hospital dressing; Device: 3M™ IV Advanced Securement dressing

• Registration Number: NCT01773564
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

randomized controlled trial of 2 intravascular dressings in Intensive care unit

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-23
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 628

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Available current hospital dressing	Current hospital dressing	Control group: depending on the type of dressing available at the hospital, either 3M™ HP Dressing or Smith \& Nephew IV3000 ™
3M™ IV Advanced Securement dressing	3M™ IV Advanced Securement dressing	New generation transparent dressing

Primary Outcome Measures

Name	Time	Method
Number of catheters presenting any kind of complications..	From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Number of catheter infections related to poor adherent dressings.	From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France