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Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841330
Recruitment Status : Completed
First Posted : April 12, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

Study Description
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Brief Summary:
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.

Condition or disease Intervention/treatment
Peripheral Intavenous Catheter Stabilization 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 Design
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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
Actual Study Start Date : June 9, 2021
Actual Primary Completion Date : July 20, 2021
Actual Study Completion Date : July 20, 2021
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Securis™ Stabilization Device Securement Failure During Simulated Use [ Time Frame: 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

  2. Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use [ Time Frame: 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


Secondary Outcome Measures :
  1. Rate of Securis™ Stabilization Device-related Adverse Events [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841330


Locations
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United States, New Jersey
TKL Research, Inc
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
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Principal Investigator: Michael Casser, MD TKL Research, Inc.
More Information
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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT04841330    
Other Study ID Numbers: MDS-20SECUR001
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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