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Evaluation of Safe Use of SECURIDRAP® SELFIA®
Sponsor: Groupe Mulliez-Flory
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.
Official title: Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2022-05-18
Completion Date
2025-07-30
Last Updated
2024-11-20
Healthy Volunteers
No
Interventions
SECURIDRAP® SELFIA®
Use of SECURIDRAP® SELFIA® for 15 night
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
CHU Lille
Lille, France
Ussap- Asm Limoux
Limoux, France
CHU Lyon
Lyon, France
CHU Rennes
Rennes, France
CHG Roubaix
Roubaix, France
CSSR La Clauze
Saint-Jean-Delnous, France