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Clinical Trials/NCT02805335
NCT02805335
Unknown
Not Applicable

Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS

University Hospital, Caen1 site in 1 country500 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Catheter Complications
Sponsor
University Hospital, Caen
Enrollment
500
Locations
1
Primary Endpoint
morbidity assessed as a composite of:
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • cost(1 year)
  • quality of life(1 year)
  • efficacy of urokinase(1 year)

Study Sites (1)

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