A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices

Completed

Conditions studied: Peripheral Intravenous Catheter Stabilization

In brief

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 (Foam Strip) and to meet the design input requirements.

Key facts

Study ID

NCT04845906

Run by

Becton, Dickinson and Company

People needed

120

Starts

2021-07-13

Expected to finish

2021-08-23

Last updated by the study team

2021-09-08

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• TKL Research, Inc — Fair Lawn, New Jersey, United States
• Dermico, LLC — Broomall, Pennsylvania, United States

Full record on ClinicalTrials.gov

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