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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

Tracking Information
First Submitted Date  ICMJE November 28, 2014
First Posted Date  ICMJE December 8, 2014
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • Number of accidental removals [ Time Frame: at catheter removal which is expected on an average after 2 weeks or up to 26 weeks ]
  • 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
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SecurAcath Versus Statlock for PICC Securement
Official Title  ICMJE Comparing SecurAcath Versus StatLock to Secure Peripherally Inserted Central Catheters: a Randomised, Open Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Patients With Any Condition Who Need a PICC for IV Therapy
Intervention  ICMJE
  • Device: SecurAcath
    Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC
    Other Name: Subcutaneous catheter securement system
  • Device: StatLock
    Device secures PICC however, device has to be changed weekly
    Other Name: Sutureless adhesive-backed device
Study Arms  ICMJE
  • Experimental: SecurAcath
    Subcutaneous securement
    Intervention: Device: SecurAcath
  • Active Comparator: StatLock
    Adhesive securement
    Intervention: Device: StatLock
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2015)
105
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2014)
102
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02311127
Other Study ID Numbers  ICMJE S57358
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Godelieve A Goossens, PhD, RN Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP