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

NCT02805335 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2017-02-01

No results posted yet for this study

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.

Conditions

  • Catheter Complications
  • Thrombosis
  • Displacement of Infusion Catheter
  • Quality of Life

Interventions

DEVICE

KTFIX PLUS

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Audrey Fohlen, MD MSc · Medical and University Center of Caen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02805335 on ClinicalTrials.gov