Patients With Any Condition Who Need a PICC for IV TherapySecurAstaPNCT02311127
SecurAcath Versus Statlock for PICC Securement
A study testing SecurAcath and StatLock in people with Patients With Any Condition Who Need a PICC for IV Therapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Any Condition Who Need a PICC for IV Therapy
- What is being tested?
- SecurAcath and StatLock
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Polyurethane PICC insertion
- Dutch speaking patient, able to give informed consent
- Intravenous treatment is administered in the University Hospitals Leuven
Who cannot join
- patients with known allergy to nickel or ethylene oxide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- SecurAcath, StatLock
- Keywords
- Peripherally Inserted Central Catheters, Securement device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecurAcathDevice
Also called Subcutaneous catheter securement system
Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC
StatLockDevice
Also called Sutureless adhesive-backed device
Device secures PICC however, device has to be changed weekly
| Study group | Role | What they receive |
|---|---|---|
| SecurAcath | Experimental | Subcutaneous securement Receives: Device: SecurAcath |
| StatLock | Active comparator | Adhesive securement Receives: Device: StatLock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed for dressing change
Measured: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Secondary outcomes (5)
Number of accidental removals
Measured: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Number of catheters that migrated
external catheter part will be measured
Measured: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Catheter-related infection
Labo confirmed catheter-related infection
Measured: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Pain at catheter entry site related to device
measured by the VAS from 0 (no pain) to 10 (worst imaginable pain)
Measured: every week with the catheter dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Ease of use of the device
measured by the sumscore of the answers on 4 statements scored on a 5-item likert scale
Measured: at placement (day 1) and at catheter removal which is expected on an average after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients With Any Condition Who Need a PICC for IV TherapyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Godelieve A Goossens, PhD, RN, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311127
- Sponsor's protocol ID
- S57358
- Acronym
- SecurAstaP
- Status last verified
- Aug 2015
- First submitted
- 28 Nov 2014
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23558917Elen 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.
PubMed 24464053Alekseyev 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.
PubMed 23243786Goossens 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.
PubMed 29478011
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial
- ClinicalTrials.gov ID
- NCT02311127
- Acronym / sponsor ID
- SecurAstaP / S57358
- Keywords
- Peripherally Inserted Central Catheters, Securement device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Dec 2014 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SecurAcath | Experimental | Device: SecurAcathSubcutaneous securement |
| StatLock | Active comparator | Device: StatLockAdhesive securement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Polyurethane PICC insertion
- Dutch speaking patient, able to give informed consent
- Intravenous treatment is administered in the University Hospitals Leuven
Key exclusion criteria (1 listed)
- patients with known allergy to nickel or ethylene oxide
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 |
|---|---|---|
| SecurAcathAlso: Subcutaneous catheter securement systemDevices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC | Device | SecurAcath |
| StatLockAlso: Sutureless adhesive-backed deviceDevice secures PICC however, device has to be changed weekly | Device | StatLock |
Primary outcome
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
5 secondary outcomes
Number of accidental removals
Time frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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
Catheter-related infection
Time frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Background: PubMed 23558917Egan 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.
- Background: PubMed 24464053Elen 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.
- Background: PubMed 23243786Alekseyev 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.
- Derived from this study: PubMed 29478011Goossens 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.
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.
Godelieve A Goossens, PhD, RN principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SecurAcath and StatLock in people with Patients With Any Condition Who Need a PICC for IV Therapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 24 Dec 2015. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311127, which also lists 4 linked publications.
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 24 Dec 2015.