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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01773564
First received: November 7, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition
Complication of Catheter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.

Further study details as provided by University Hospital, Grenoble:

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: 670
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tegaderm HP
Tegaderm Advanced IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients in Intensive Care Unit requiring at least one intravascular device.

Criteria

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
  Contacts and Locations
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

Contacts
Contact: Jean François TIMSIT, PI/PH 0476768779 jftimsit@chu-grenoble.fr
Contact: Silvia Calvino, RN 0476767109 scalvino-gunther@chu-grenoble.fr

Locations
France
University Hospital of Grenoble Recruiting
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         
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01773564     History of Changes
Other Study ID Numbers: 12SC03, 2012-A00734-39
Study First Received: November 7, 2012
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Dressings, Prevention,

ClinicalTrials.gov processed this record on September 14, 2014