Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

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

Study Overview

• Status: Completed
• Conditions: Peripheral Intavenous Catheter Stabilization
• Intervention / Treatment: Device: Securis™ Stabilization Device

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy volunteers; A minimum of 100 healthy volunteer participants (14yo and older)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Michael Casser, MD, TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MDS-20SECUR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No