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Advanced: Comparison of Two New Generations Dressings in Intensive Care Unit

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT01795391
Collaborator
(none)
685
Enrollment
1
Location
13
Duration (Months)
52.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    685 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Nov 1, 2013
    Actual Study Completion Date :
    Nov 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Tegaderm HP

    Patients whose intravasculare devices dressings are made exclusevely with Tegaderm HP dressings.
    Advanced

    Patients whose intravasculare devices dressings are made exclusevely with Advanced dressings

    Outcome Measures

    Primary Outcome Measures

    1. Number of catheters presenting any kind of complications. [From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.]

    Secondary Outcome Measures

    1. Number of infections related to poor adherent dressings. [From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.]

    Other Outcome Measures

    1. Number of participants presenting allergic adverse events. [From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.]

    2. Cost of each dressing type strategy. [From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Hospital of Grenoble, Medical Intensive Care Unit Grenoble Isère France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT01795391
    Other Study ID Numbers:
    • ADVANCED
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    Jan 22, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by University Hospital, Grenoble
    Prevention
    Dressings
    Catheters

    Study Results

    No Results Posted as of Jan 22, 2014