Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

Peripheral Intavenous Catheter Stabilization Clinical Trial

Official title:

Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841330
• Other study ID #: MDS-20SECUR001
• Status: Completed
• Start date: June 9, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: September 2021
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.

Description:

This study is designed to collect prospective observational data related to the safety and performance of the Securis™ Stabilization Device in healthy volunteers utilizing a simulated use method. Participants will have an intravenous catheter applied (not inserted) onto their forearm with a Securis™ Stabilization Device applied over it. The site/device will be assessed over a period of 9 days (ideally Days 0-7 in-clinic and Day 8 virtually). The assessments will include the appearance of the site, the appearance of the dressing, and the movement of the catheter tip under the dressing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

1. =14 years of age, regardless of gender, at the time of informed consent

2. Is expected to be available through Day 8 of the study

3. Is expected to understand and follow the study procedures including applicable restrictions in activities (e.g., limited physical exercise, no swimming, no use of lotions/moisturizers, etc.)

4. Provision of signed and dated informed consent form. Note: Consent of a parent of legal guardian will be require for participants <18 years of age; assent will also be required for these participants

Exclusion Criteria:

1. Significant scarring at the device application site

2. Has any skin condition that might affect device adherence or the ability of study staff to perform skin assessments

3. Has any condition or is taking any medication that might cause excessive bruising, bleeding, or skin tearing (e.g., anti-coagulant therapy)

4. Known allergy to study device/components or ancillary devices

5. Will be unable to complete a remote visit via video chat, if required

6. Has any condition which, in the opinion of the Investigator, precludes them from participation in this study.

Related Conditions & MeSH terms

• Peripheral Intavenous Catheter Stabilization

Intervention

Device:
• Securis™ Stabilization Device
A trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use.

Locations

Country	Name	City	State
United States	TKL Research, Inc	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Securis™ Stabilization Device Securement Failure During Simulated Use	Device securement failure is defined as any of the following: Loose dressing; Soiled under dressing; Complete failure (complete removal); Dislodgement of device or catheter	From time of placement and up to 8 days after removal
Primary	Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use	Select skin conditions include any of the following: Blister; Rash; Skin tear; Bruising; Exudate	From placement and up tp to 24 hours after device removal
Secondary	Rate of Securis™ Stabilization Device-related Adverse Events	Rate of device-related adverse events calculated as the number of participants with adverse events related to the device divided by the total number of evaluable participants.	From placement and up to 24 hours after device removal