Status:
COMPLETED
A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Peripheral Intravenous Catheter Stabilization
Eligibility:
All Genders
14+ years
Brief Summary
This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (F...
Detailed Description
This is a healthy human wear study of a minimum of 100 study participants who will wear the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip). Parti...
Eligibility Criteria
Inclusion
- Any healthy human, 14 years of age or older, regardless of gender (Note: Consent of guardian or parent may be required for patients who are under 18 years of age).
- If they provide written and informed consent.
- Expected to be available for observation from consent, to the application on Day 0, and then removal of the StatLock™ Catheter Stabilization Device on Day 7, and for a follow up phone and/or video call on Day 8 for a skin assessment.
- Participant agrees to maintain a diary from device application, Day 0, through device removal, Day 7.
- Agree to keep the StatLock™ Catheter Stabilization Device, ancillary products, and site dry throughout the study
- Agrees to not use moisturizers, lotions, or any product labeled moisturizing for the duration of the study, at or around the site where the devices will be applied (inner (ventral) forearm).
Exclusion
- If their skin was burned or scarred at the insertion site, or has any other skin condition which may affect the adherence and/or interpretation of the study results.
- If they have a known allergy to the study products (known tape or adhesive allergy).
- Has a medical condition which may prevent him or her from completing the study or place the study participant at undue risk.
Key Trial Info
Start Date :
July 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 23 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04845906
Start Date
July 13 2021
End Date
August 23 2021
Last Update
September 8 2021
Active Locations (2)
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1
TKL Research, Inc
Fair Lawn, New Jersey, United States, 07410
2
Dermico, LLC
Broomall, Pennsylvania, United States, 19008