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SecurAcath Versus Statlock for PICC Securement

Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02311127
Acronym
SecurAstaP
Enrollment
105
Registered
2014-12-08
Start date
2015-04-30
Completion date
2015-12-31
Last updated
2015-12-24

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

Conditions

Patients With Any Condition Who Need a PICC for IV Therapy

Keywords

Peripherally Inserted Central Catheters, Securement device

Brief 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. 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.

Interventions

DEVICESecurAcath

Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC

DEVICEStatLock

Device secures PICC however, device has to be changed weekly

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

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
No

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

Design outcomes

Primary

MeasureTime frame
Time needed for dressing changeweekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks

Secondary

MeasureTime frameDescription
Number of accidental removalsat catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Number of catheters that migratedweekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeksexternal catheter part will be measured
Catheter-related infectionat catheter removal which is expected on an average after 2 weeks or up to 26 weeksLabo confirmed catheter-related infection
Pain at catheter entry site related to deviceevery week with the catheter dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeksmeasured by the VAS from 0 (no pain) to 10 (worst imaginable pain)
Ease of use of the deviceat placement (day 1) and at catheter removal which is expected on an average after 2 weeksmeasured by the sumscore of the answers on 4 statements scored on a 5-item likert scale

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026