Evaluation of Safe Use of SECURIDRAP® SELFIA®

Groupe Mulliez-Flory

Status

Enrolling

Conditions

Disorientation

Cognitive Impairment

Behavior Disorders

Treatments

Other: SECURIDRAP® SELFIA®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05510401

2019-A03234-53

Details and patient eligibility

About

Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.

Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.

Full description

The proposed study is a prospective, multicenter, interventional and non-comparative research.

This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.

This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.

The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient at least 18 years old
Patient having a medical prescription for SÉCURIDRAP® SELFIA®
Patient in phase or state of disorientation
Patient with nocturnal behavior disordre
Patient with major cognitive impairment
Patient at risk of falling into bed
Patient subject to guardianship or curatorship
Patient beneficiary or affiliated to a social security scheme
Patient who has given their participation agreement aand informed consent

Exclusion criteria

Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
Patient in psychiatry
Patient with severe agitation
Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
Patient with intolerance to the medical device
Patient able to extract himself from SÉCURIDRAP® SELFIA®
Patient able to unlock the bed rails by himself
Patient without social coverage or not benefiting from it through a third party
Patient minor, pregnant woman, persons deprived of their liberty
Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion