Clinical trial NCT02311127: SecurAcath Versus Statlock for PICC Securement
Official title: Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Any Condition Who Need a PICC for IV Therapy
Keywords: Peripherally Inserted Central Catheters
Securement device
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time needed for dressing change
timeFrame: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
Secondary outcomes:
measure: Number of accidental removals
timeFrame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
measure: Number of catheters that migrated
timeFrame: weekly during dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
measure: Catheter-related infection
timeFrame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks
measure: Pain at catheter entry site related to device
timeFrame: every week with the catheter dressing change until catheter removal which is expected on an average after 2 weeks or up to 26 weeks
measure: Ease of use of the device
timeFrame: at placement (day 1) and at catheter removal which is expected on an average after 2 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Godelieve A Goossens, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.