Comparison of Two New Generation Dressings in Intensive Care (ADVANCED)
Verified January 2013 by University Hospital, Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
First received: November 7, 2012
Last updated: January 22, 2013
Last verified: January 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of catheter 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 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- Costs 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Tegaderm Advanced IV
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients in Intensive Care Unit requiring at least one intravascular device.
- 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.
- Patients under 18 years of age,
- Patients having known allergy or sensitivity to adhesive dressing materials
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01773564
|University Hospital of Grenoble
|Grenoble, France, 38043 |
|Sub-Investigator: Carole SCHWEBEL, PU/PH |
|Sub-Investigator: Claire ARA SOMOHANO, PH |
|Sub-Investigator: Agnès BONADONA, PH |
|Sub-Investigator: Rebecca HAMIDFAR-ROY, PH |
|Sub-Investigator: Maxime LUGOSI, Assistant |
|Sub-Investigator: Clemence MINET, PH |
|Sub-Investigator: Leïla POTTON, Assistant |
University Hospital, Grenoble
No publications provided
||University Hospital, Grenoble
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 7, 2012
||January 22, 2013
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by University Hospital, Grenoble:
ClinicalTrials.gov processed this record on October 19, 2014