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

This study is currently recruiting participants.
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
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 April 17, 2014