Comparison of Two New Generations Dressings in Intensive Care Unit
Advanced
Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units
1 other identifier
observational
685
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 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 all trials
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
February 18, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 22, 2014
January 1, 2014
1.1 years
February 18, 2013
January 20, 2014
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 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.
Cost 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)
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
Eligibility Criteria
Patients hospitalised in the Medical ICU and requiring an intravascular device during hospitalisation (peripheral or central)
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, Medical Intensive Care Unit
Grenoble, Isère, 38043, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2013
First Posted
February 20, 2013
Study Start
October 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
January 22, 2014
Record last verified: 2014-01