NCT05510401

Evaluation of Safe Use of SECURIDRAP® SELFIA®

Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Groupe Mulliez-Flory · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Disorientation
• Cognitive Impairment
• Behavior Disorders

Interventions

Type	Name	Description
OTHER	SECURIDRAP® SELFIA®	Use of SECURIDRAP® SELFIA® for 15 night

Timeline

• Start date: 2022-05-18
• Primary completion: 2025-03-30
• Completion: 2025-07-30
• First posted: 2022-08-22
• Last updated: 2024-11-20

Locations

10 sites across 1 country: France