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

Caen University Hospital

Status: Unknown

Conditions: Displacement of Infusion Catheter; Quality of Life; Thrombosis; Catheter Complications

Treatments: Device: KTFIX PLUS

Study type: Interventional

Funder types: Other

Identifiers

NCT02805335

2014-A01303-44

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Control group

No Intervention group

Description:

Group with the sutureless device actually used

Innovative group

Experimental group

Description:

Group with the new device ( KTFIX PLUS)

Treatment:

Device: KTFIX PLUS