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SecurAcath Versus Statlock for PICC Securement (SecurAstaP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311127
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment Phase
Patients With Any Condition Who Need a PICC for IV Therapy Device: SecurAcath Device: StatLock Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: SecurAcath
Subcutaneous securement
Device: SecurAcath
Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC
Other Name: Subcutaneous catheter securement system

Active Comparator: StatLock
Adhesive securement
Device: StatLock
Device secures PICC however, device has to be changed weekly
Other Name: Sutureless adhesive-backed device




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of accidental removals [ Time Frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks ]
  2. 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

  3. 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

  4. 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)

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311127


Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Godelieve A Goossens, PhD, RN Universitaire Ziekenhuizen Leuven
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02311127    
Other Study ID Numbers: S57358
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: August 2015
Keywords provided by Universitaire Ziekenhuizen Leuven:
Peripherally Inserted Central Catheters
Securement device