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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01773564
First received: November 7, 2012
Last updated: June 14, 2016
Last verified: June 2016
  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 Intervention
Complication of Catheter
Device: Current hospital dressing
Device: 3M™ IV Advanced Securement dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.

Resource links provided by NLM:


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 ]

Enrollment: 628
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Available current hospital dressing
Control group: depending on the type of dressing available at the hospital, either 3M™ HP Dressing or Smith & Nephew IV3000 ™
Device: Current hospital dressing
Patients were assigned to either arm following a randomization scheme 1:1.
Other Name: 3M™ HP Dressing or Smith & Nephew IV3000 ™
Experimental: 3M™ IV Advanced Securement dressing
New generation transparent dressing
Device: 3M™ IV Advanced Securement dressing
Patients were assigned to either arm following a randomization scheme 1:1.

Detailed Description:
randomized controlled trial of 2 intravascular dressings in Intensive care unit
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

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: June 14, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 26, 2016