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

January 31, 2017 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France, 14033
        • Recruiting
        • CAEN university Hospital
        • Contact:
          • Audrey FOHLEN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 1 year
internal satisfaction scale
1 year
cost
Time Frame: 1 year
direct costs of PICCS fastening systems
1 year
efficacy of urokinase
Time Frame: 1 year
recanalization rates of PICC after application of urokinase protocol
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Audrey Fohlen, MD MSc, Medical and University Center of Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01303-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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