Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

Completed

• Conditions: Peripheral Intavenous Catheter Stabilization
• Interventions: Device: Securis™ Stabilization Device

• Registration Number: NCT04841330
• Lead Sponsor: Becton, Dickinson and Company

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Study Start: 2021-06-09
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Securis™ Stabilization Device	A minimum of 100 healthy volunteer participants (14yo and older)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use	From placement and up tp to 24 hours after device removal	Select skin conditions include any of the following: * Blister; * Rash; * Skin tear; * Bruising; * Exudate
Rate of Securis™ Stabilization Device Securement Failure During Simulated Use	From time of placement and up to 8 days after removal	Device securement failure is defined as any of the following: * Loose dressing; * Soiled under dressing; * Complete failure (complete removal); * Dislodgement of device or catheter

Secondary Outcome Measures

Name	Time	Method
Rate of Securis™ Stabilization Device-related Adverse Events	From placement and up to 24 hours after device removal	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.

Trial Locations

Locations (1)

TKL Research, Inc; 🇺🇸 Fair Lawn, New Jersey, United States