SecurAcath Versus Statlock for PICC Securement

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients With Any Condition Who Need a PICC for IV Therapy

Intervention / Treatment
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* Device: SecurAcath
* Device: StatLock


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SecurAcath<br>Subcutaneous securement | Device: SecurAcath<br>* Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC<br>* Other names: Subcutaneous catheter securement system;|
| Active Comparator: StatLock<br>Adhesive securement | Device: StatLock<br>* Device secures PICC however, device has to be changed weekly<br>* Other names: Sutureless adhesive-backed device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed for dressing change |  | weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of accidental removals |  | 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 | 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 | 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) | 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 | at placement (day 1) and at catheter removal which is expected on an average after 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripherally Inserted Central Catheters, Securement device