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

Not Applicable

• Conditions: Catheter Complications; Quality of Life; Thrombosis; Displacement of Infusion Catheter
• Interventions: Device: KTFIX PLUS

• Registration Number: NCT02805335
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study Start: 2016-04
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Innovative group	KTFIX PLUS	Group with the new device ( KTFIX PLUS)

Primary Outcome Measures

Name	Time	Method
morbidity assessed as a composite of:	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

Name	Time	Method
cost	1 year	direct costs of PICCS fastening systems
quality of life	1 year	internal satisfaction scale
efficacy of urokinase	1 year	recanalization rates of PICC after application of urokinase protocol

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France