Completed

NCT Number: NCT02311127

SecurAcath Versus Statlock for PICC Securement

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.

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Key information

Conditions

Patients With Any Condition Who Need a PICC for IV Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SecurAcath

Device

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

Other names: Subcutaneous catheter securement system

StatLock

Device

Device secures PICC however, device has to be changed weekly

Other names: Sutureless adhesive-backed device

Primary outcomes

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

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

external catheter part will be measured
Catheter-related infection

Time frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks

Labo confirmed catheter-related infection
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

measured by the VAS from 0 (no pain) to 10 (worst imaginable pain)
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

measured by the sumscore of the answers on 4 statements scored on a 5-item likert scale

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: SecurAstaP

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Dec 8, 2014
Registry last updated: Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.