SecurAcath Versus Statlock for PICC Securement (SecurAstaP)
December 23, 2015 updated by: Universitaire Ziekenhuizen KU Leuven
Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial
Peripherally inserted central catheters (PICCs ) are used for the administration of intravenous fluids and for blood sampling.
PICCs may remain in place for weeks to months and are safeguarded from migration or accidental dislodgement by securement devices.
Different types of these devices are available.
StatLock® (C.R. Bard) is a stabilization device with an adhesive anchor pad.
The catheter wings of the PICC must be placed over the posts then the system is closed with "gull-wings" .
StatLock® has to be changed weekly.
Healthcare providers have to pay attention to prevent accidental catheter dislodgement during the renewal procedure.
SecurAcath® (Interrad Medical) is a new securement device to the European market.
The device uses a small subcutaneous anchor to secure the PICC.
One of the advantages compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying dressing changes and subsequently staff time.
It is described that nurses report that care is left undone due to low staffing levels.
Therefore, investigation of nursing time savings with the support of technology is imperative.
SecurAcath® remains in place for life of the PICC and therefore has the potential to reduce the time for dressing change as there is no need for weekly device change.
The objective of this study is to measure nursing time for dressing change and explore inserting and removal issues and patient experiences.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- University Hospitals Leuven
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Polyurethane PICC insertion
- Dutch speaking patient, able to give informed consent
- Intravenous treatment is administered in the University Hospitals Leuven
Exclusion Criteria:
- patients with known allergy to nickel or ethylene oxide
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SecurAcath
Subcutaneous securement
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Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC
Other Names:
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Active Comparator: StatLock
Adhesive securement
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Device secures PICC however, device has to be changed weekly
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time needed for dressing change
Time Frame: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of accidental removals
Time Frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
|
at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
|
|
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Number of catheters that migrated
Time Frame: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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external catheter part will be measured
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weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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Catheter-related infection
Time Frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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Labo confirmed catheter-related infection
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at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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Pain at catheter entry site related to device
Time Frame: every week with the catheter dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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measured by the VAS from 0 (no pain) to 10 (worst imaginable pain)
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every week with the catheter dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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Ease of use of the device
Time Frame: at placement (day 1) and at catheter removal which is expected on an average after 2 weeks
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measured by the sumscore of the answers on 4 statements scored on a 5-item likert scale
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at placement (day 1) and at catheter removal which is expected on an average after 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Godelieve A Goossens, PhD, RN, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Egan GM, Siskin GP, Weinmann R 4th, Galloway MM. A prospective postmarket study to evaluate the safety and efficacy of a new peripherally inserted central catheter stabilization system. J Infus Nurs. 2013 May-Jun;36(3):181-8. doi: 10.1097/NAN.0b013e3182893690.
- Elen Hughes M. Reducing PICC migrations and improving patient outcomes. Br J Nurs. 2014 Jan 23-Feb 12;23(2):S12, S14-8. doi: 10.12968/bjon.2014.23.sup1.s12.
- Alekseyev S, Byrne M, Carpenter A, Franker C, Kidd C, Hulton L. Prolonging the life of a patient's IV: an integrative review of intravenous securement devices. Medsurg Nurs. 2012 Sep-Oct;21(5):285-92.
- Goossens GA, Grumiaux N, Janssens C, Jerome M, Fieuws S, Moons P, Stas M, Maleux G. SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial. BMJ Open. 2018 Feb 24;8(2):e016058. doi: 10.1136/bmjopen-2017-016058.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 28, 2014
First Submitted That Met QC Criteria
December 4, 2014
First Posted (Estimate)
December 8, 2014
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 23, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- S57358
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.