View Clinical Trial (Medical Research Study)
Prospective SecurAcath Subcutaneous Securement Clinical Trial
| City: |
|
St. Paul |
| State: |
|
Minnesota |
| Zip Code: |
|
55102 |
| Conditions: |
|
Peripherally Inserted Central Catheter |
| 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.
|
| Study Summary: |
|
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.
|
| 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.
|
| NCT ID: |
|
NCT00903539 |
| Primary Contact: |
|
Robin Euphosin
Phone: 763-477-5606
Email: reuphosin@libramed.com
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
St. Paul, Minnesota 55102
United States
Kathleen Madden, CNP
Phone: 651-232-3183
Email: kmadden@stpaulrad.com
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 20, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|