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Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS (KTFIXPICC)

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ClinicalTrials.gov Identifier: NCT02805335
Recruitment Status : Unknown
Verified January 2017 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines it's recommended to use sutureless device. The devices actually used are unsatisfactory because of the high risk of migration, accidental removal.

A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the possibility to simplify the after care. This device may stay on patient for 4 weeks. Others devices may be changed 1/week.

The investigators aimed to compare morbidity between this new device and the old one. The investigators also want to perform an economic evaluation of this device and compare patient quality of life.


Condition or disease Intervention/treatment Phase
Catheter Complications Thrombosis Displacement of Infusion Catheter Quality of Life Device: KTFIX PLUS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
No Intervention: Control group
Group with the sutureless device actually used
Experimental: Innovative group
Group with the new device ( KTFIX PLUS)
Device: KTFIX PLUS



Primary Outcome Measures :
  1. morbidity assessed as a composite of: [ Time Frame: from baseline up to 1 year ]
    • Catheter infection
    • Symptomatic superficial or deep venous thrombosis
    • Catheter occlusion
    • Premature withdrawal
    • Catheter migration
    • Hematoma occurred within 24 hours after installation in incidence density


Secondary Outcome Measures :
  1. quality of life [ Time Frame: 1 year ]
    internal satisfaction scale

  2. cost [ Time Frame: 1 year ]
    direct costs of PICCS fastening systems

  3. efficacy of urokinase [ Time Frame: 1 year ]
    recanalization rates of PICC after application of urokinase protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patient with indication for PICC according guidelines
  • hospitalized in a departement of your hospital
  • with the possibility to use a sutureless device

Exclusion Criteria:

  • infection
  • thrombosis
  • pediatric patient
  • emergency context

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805335


Contacts
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Contact: Audrey Fohlen, MD MSc +33666577519 fohlen-a@chu-caen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, France, 14033
Contact: Audrey FOHLEN, MD         
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Audrey Fohlen, MD MSc Medical and University Center of Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02805335    
Other Study ID Numbers: 2014-A01303-44
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University Hospital, Caen:
Central Venous Catheter
Catheter Bloodstream Related Infection
Economic evaluation
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases