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

Quality of Life Clinical Trial

— KTFIXPICC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02805335
• Other study ID #: 2014-A01303-44
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2016
• Last updated: January 31, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: Audrey Fohlen, MD MSc
• Phone: +33666577519
• Email: fohlen-a[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• KTFIX PLUS

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity assessed as a composite of:	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	quality of life	internal satisfaction scale	1 year
Secondary	cost	direct costs of PICCS fastening systems	1 year
Secondary	efficacy of urokinase	recanalization rates of PICC after application of urokinase protocol	1 year