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Prospective SecurAcath Subcutaneous Securement Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Interrad Medical
ClinicalTrials.gov Identifier:
NCT00903539
First received: May 14, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

To prospectively monitor the safety and performance of the catheter securement device in subjects whose catheter is secured with the Interrad Medical SecureAcath device.


Condition Intervention
Central Venous Catheter
Device: SecurAcath Securement System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective SecurAcath Subcutaneous Securement Clinical Trial

Further study details as provided by Interrad Medical:

Primary Outcome Measures:
  • Device Securement Success: defined as the percent of devices implanted and explanted without malfunction or device related complications attributed to the subcutaneous securement system. [ Time Frame: Timeframe is the length of time the patient has the catheter in place. Can vary depending on the indication for the catheter (anywhere from 48 hours post-procedure to 6 months or more). ] [ Designated as safety issue: Yes ]

Enrollment: 217
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SecurAcath Securement System
    Subcutaneous catheter securement system
    Other Name: PICC securement system
Detailed Description:

Peripherally inserted central catheters (PICCs) and Central Venous Catheter (CVC) are widely used to deliver fluids directly to the central venous system and can remain in place for as short as a few days to as long as months. One of the highest risks in the use of these catheters is infection, both local and systemic. Currently, these catheters are secured by either sutures or adhesive patches. Sutures can create additional potential entry points for bacteria whereas both sutures and adhesive securement patches hold the catheter hub to the skin resulting in increased difficulty cleaning around the catheter entry site. Furthermore, securing a catheter outside the skin away from the catheter entry point, as with sutures or adhesive securement patches may potentiate pistoning of the catheter which is also believed to possibly increase infection risks. A second risk of intravenous catheter use is dislodgement during normal use and site maintenance. These catheters are often manipulated multiple times a day for blood sampling or injection of fluids. During manipulation, the catheter can be dislodged thus requiring an unplanned replacement of the catheter.

Interrad Medical has developed a means to secure indwelling catheters using a small subcutaneous anchor. With this system, cleaning around the catheter entry site is made easier and can be more thorough. The system is also designed to minimize the risk of catheter dislodgement because once the anchor is deployed, the catheter remains secured. This may simplify dressing changes compared to adhesive devices such as Statlock, which requires the catheter be released from the device and therefore be unsecured during dressing changes.

The objective of this post-market study is to monitor the safety and performance of the SecurAcath when used to secure the catheter to the insertion site via a subcutaneous anchor. The data collected may provide insight for future enhancements to improve the safety and utility of the device. It also provides a means for an early warning of any identified safety issues, and allows physicians to share their experiences thereby improve the quality of care provided to the patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients indicated to have a central catheter placed at a hospital or private practice clinic are included in the study population.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Requires an intravenous catheter to be placed

Exclusion Criteria:

  • Inability to understand the study or a history of non-compliance with medical advice.
  • Unwilling or unable to sign Informed Consent Form (ICF).
  • Had a previous catheter placed in the same side within the last 3 months.
  • Known central venous thrombosis or occlusion or stenosis on the side of the body to be used for the catheter.
  • History of upper extremity venous thrombosis on the side of the body to be used for the catheter.
  • Known hypercoagulable disorder.
  • Diffuse skin inflammatory condition or rashes on the side to be used for the catheter line.
  • Peripheral chemotherapy therapy in the same side as that to be used for the catheter line within 3 months.
  • Known hypersensitivity to nickel.
  • Any infection associated with positive blood cultures that are still present after 48 hours of antibiotic therapy.
  • Previous mastectomy or axillary lymph node dissection on the same side as catheter implant.
  • Subjects on chronic or recurrent systemic steroid medications for 6 months or longer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903539

Locations
United States, Minnesota
North Memorial Hospital - Minneapolis Radiology
Robbinsdale, Minnesota, United States, 55422
HealthEast St. Joseph's Hospital
St. Paul, Minnesota, United States, 55102
United States, Nevada
Great Basin Imaging
Carson City, Nevada, United States, 89706
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Interrad Medical
  More Information

No publications provided

Responsible Party: Interrad Medical
ClinicalTrials.gov Identifier: NCT00903539     History of Changes
Other Study ID Numbers: 1180-001
Study First Received: May 14, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Interrad Medical:
Peripherally Inserted Central Catheter
Central Venous Catheter
Intravenous Catheter
StatLock
Patients indicated to have an intravenous catheter placed

ClinicalTrials.gov processed this record on November 24, 2014