SecurAcath Versus Statlock for PICC Securement

NCT02311127 | Completed

• 1 other identifier: S57358
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Any Condition Who Need a PICC for IV Therapy

Keywords

Peripherally Inserted Central Catheters; Securement device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

  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

  at placement (day 1) and at catheter removal which is expected on an average after 2 weeks

Study Arms (2)

SecurAcath

EXPERIMENTAL

Subcutaneous securement

Device: SecurAcath

StatLock

ACTIVE COMPARATOR

Adhesive securement

Device: StatLock

Interventions

SecurAcath DEVICE

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

Also known as: Subcutaneous catheter securement system

SecurAcath

StatLock DEVICE

Device secures PICC however, device has to be changed weekly

Also known as: Sutureless adhesive-backed device

StatLock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Polyurethane PICC insertion
• Dutch speaking patient, able to give informed consent
• Intravenous treatment is administered in the University Hospitals Leuven

You may not qualify if:

• patients with known allergy to nickel or ethylene oxide

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

• 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.

  PMID: 23558917 BACKGROUND

• Elen 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.

  PMID: 24464053 BACKGROUND

• Alekseyev 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.

  PMID: 23243786 BACKGROUND

• Goossens 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.

  PMID: 29478011 DERIVED

Study Officials

• Godelieve A Goossens, PhD, RN

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 8, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-08

Locations

BE (1)