Evaluation of Safe Use of SECURIDRAP® SELFIA®
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Mulliez-Flory
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 groupSponsors and collaborators
Groupe Mulliez-Flory
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov