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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805335

Acronym

KTFIXPICC

Enrollment

500

Registered

2016-06-20

Start date

2016-04-30

Completion date

2017-12-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Central Venous Catheter, Catheter Bloodstream Related Infection, Economic evaluation

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.

Interventions

DEVICEKTFIX PLUS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Contacts

Primary ContactAudrey Fohlen, MD MSc

fohlen-a@chu-caen.fr+33666577519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026