Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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®

Trial design

Treatments tested in this trial

  • SECURIDRAP® SELFIA®

Treatment groups

108 Participants
are divided into 1 treatment group

Locations

10
CMMF de Bailleul Bailleul France
EHPAD l'Aquarelle Bully-les-Mines France
Centre Hospitalier d'Hazebrouck Hazebrouck France
Centre Hospitalier Le Quesnoy Le Quesnoy France

Sponsors and collaborators

Groupe Mulliez-Flory

Lead sponsor

EVAMED

Collaborator

Source ClinicalTrials.gov