Catheter ComplicationsKTFIXPICCNCT02805335
Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS
A study testing KTFIX PLUS in people with Catheter Complications and Thrombosis, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheter Complications, Thrombosis, Displacement of Infusion Catheter
- What is being tested?
- KTFIX PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient with indication for PICC according guidelines
- hospitalized in a departement of your hospital
- with the possibility to use a sutureless device
Who cannot join
- infection
- thrombosis
- pediatric patient
- emergency context
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14033
Audrey FOHLEN, MD
About this study
Official title: Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS
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.
- Being tested
- KTFIX PLUS
- Keywords
- Central Venous Catheter, Catheter Bloodstream Related Infection, Economic evaluation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTFIX PLUSDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Group with the sutureless device actually used |
| Innovative group | Experimental | Group with the new device ( KTFIX PLUS) Receives: Device: KTFIX PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline up to 1 year
Secondary outcomes (3)
quality of life
internal satisfaction scale
Measured: 1 year
cost
direct costs of PICCS fastening systems
Measured: 1 year
efficacy of urokinase
recanalization rates of PICC after application of urokinase protocol
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Fohlen, MD MSc, Principal investigator, Medical and University Center of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805335
- Sponsor's protocol ID
- 2014-A01303-44
- Acronym
- KTFIXPICC
- Status last verified
- Jan 2017
- First submitted
- 17 Mar 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS
- ClinicalTrials.gov ID
- NCT02805335
- Acronym / sponsor ID
- KTFIXPICC / 2014-A01303-44
- Keywords
- Central Venous Catheter, Catheter Bloodstream Related Infection, Economic evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Group with the sutureless device actually used |
| Innovative group | Experimental | Device: KTFIX PLUSGroup with the new device ( KTFIX PLUS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient with indication for PICC according guidelines
- hospitalized in a departement of your hospital
- with the possibility to use a sutureless device
Key exclusion criteria (4 listed)
- infection
- thrombosis
- pediatric patient
- emergency context
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KTFIX PLUS | Device | Innovative group |
Primary outcome
morbidity assessed as a composite of:
Time frame: 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
3 secondary outcomes
quality of life
Time frame: 1 year
cost
Time frame: 1 year
efficacy of urokinase
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Fohlen, MD MSc principal investigator
Medical and University Center of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KTFIX PLUS in people with Catheter Complications and Thrombosis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey Fohlen, MD MSc (+33666577519, fohlen-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity assessed as a composite of: (time frame: from baseline up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.