Patients With Any Condition Who Need a PICC for IV Therapy Clinical Trial
— SecurAstaPOfficial title:
Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial
| Verified date | August 2015 |
| Source | Universitaire Ziekenhuizen Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospitals Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
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. Review. — View 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. — View Citation
Elen Hughes M. Reducing PICC migrations and improving patient outcomes. Br J Nurs. 2014 Jan 23-Feb 12;23(2):S12, S14-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Number of accidental removals | at catheter removal which is expected on an average after 2 weeks or up to 26 weeks | No | |
| Secondary | 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 | No |
| Secondary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |