Comparison of Two New Generation Dressings in Intensive Care (ADVANCED)
This study has been completed.
Information provided by (Responsible Party):
University Hospital, Grenoble
First received: November 7, 2012
Last updated: December 5, 2014
Last verified: December 2014
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 ]
| Study Start Date:
| Study Completion Date:
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773564
|University Hospital of Grenoble
|Grenoble, France, 38043 |
University Hospital, Grenoble
No publications provided
||University Hospital, Grenoble
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 7, 2012
||December 5, 2014
||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 July 05, 2015