Comparison of Two New Generation Dressings in Intensive Care (ADVANCED)
ADVANCED
Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.
2 other identifiers
interventional
628
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 7, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJune 15, 2016
June 1, 2016
1 year
November 7, 2012
June 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Other Outcomes (2)
Number of participants presenting allergic adverse events
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.
From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
Study Arms (2)
Available current hospital dressing
ACTIVE COMPARATORControl group: depending on the type of dressing available at the hospital, either 3M™ HP Dressing or Smith \& Nephew IV3000 ™
3M™ IV Advanced Securement dressing
EXPERIMENTALNew generation transparent dressing
Interventions
Patients were assigned to either arm following a randomization scheme 1:1.
Patients were assigned to either arm following a randomization scheme 1:1.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients under 18 years of age,
- Patients having known allergy or sensitivity to adhesive dressing materials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Grenoble
Grenoble, 38043, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2012
First Posted
January 23, 2013
Study Start
October 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
June 15, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share