SecurAcath Versus Statlock for PICC Securement

Not Applicable

Completed

• Conditions: Patients With Any Condition Who Need a PICC for IV Therapy
• Interventions: Device: SecurAcath; Device: StatLock

• Registration Number: NCT02311127
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Study Start: 2015-04
• Status Verified: 2015-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SecurAcath	SecurAcath	Subcutaneous securement
StatLock	StatLock	Adhesive securement

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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	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	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	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

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium