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

Primary Purpose

Catheter Complications, Thrombosis, Displacement of Infusion Catheter

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KTFIX PLUS
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Catheter Complications focused on measuring Central Venous Catheter, Catheter Bloodstream Related Infection, Economic evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Innovative group

Arm Description

Group with the sutureless device actually used

Group with the new device ( KTFIX PLUS)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2016
Last Updated
January 31, 2017
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02805335
Brief Title
Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS
Acronym
KTFIXPICC
Official Title
Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Complications, Thrombosis, Displacement of Infusion Catheter, Quality of Life
Keywords
Central Venous Catheter, Catheter Bloodstream Related Infection, Economic evaluation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group with the sutureless device actually used
Arm Title
Innovative group
Arm Type
Experimental
Arm Description
Group with the new device ( KTFIX PLUS)
Intervention Type
Device
Intervention Name(s)
KTFIX PLUS
Primary Outcome Measure Information:
Title
morbidity assessed as a composite of:
Description
Catheter infection Symptomatic superficial or deep venous thrombosis Catheter occlusion Premature withdrawal Catheter migration Hematoma occurred within 24 hours after installation in incidence density
Time Frame
from baseline up to 1 year
Secondary Outcome Measure Information:
Title
quality of life
Description
internal satisfaction scale
Time Frame
1 year
Title
cost
Description
direct costs of PICCS fastening systems
Time Frame
1 year
Title
efficacy of urokinase
Description
recanalization rates of PICC after application of urokinase protocol
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Fohlen, MD MSc
Phone
+33666577519
Email
fohlen-a@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Fohlen, MD MSc
Organizational Affiliation
Medical and University Center of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey FOHLEN, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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