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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
108
Use of SECURIDRAP® SELFIA® for 15 night
CMMF de Bailleul
Bailleul, France
RECRUITINGEHPAD l'Aquarelle
Bully-les-Mines, France
RECRUITINGCentre Hospitalier d'Hazebrouck
Hazebrouck, France
RECRUITINGCentre Hospitalier Le Quesnoy
Le Quesnoy, France
RECRUITINGCHU Lille
Lille, France
RECRUITINGUssap- Asm Limoux
Limoux, France
RECRUITINGCHU Lyon
Lyon, France
RECRUITINGCHU Rennes
Rennes, France
RECRUITINGCHG Roubaix
Roubaix, France
RECRUITINGCSSR La Clauze
Saint-Jean-Delnous, France
RECRUITINGRate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
quotient of the number of overnight stays or at least one adverse event related to the use of SÉCURIDRAP® SELFIA® appeared, by the number of overnight stays where SÉCURIDRAP® SELFIA® was used
Time frame: [15 days]
Rate of occurrence of user errors that could endanger patient safety
These usage errors will be measured during the verification of correct use of the SÉCURIDRAP® SELFIA® by the independent assessor, 2 hours after patient has been installed in the medical device
Time frame: [15 days]
Rate of patients remaining bedridden each night for the duration of the sudy
P = \[(NNL)/ (NU)\] x 100 with: * NNL : the number of nights , patient has not released * NU : the number of use; (number of overnight stays)
Time frame: [15 days]
Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient
Time saving for healthcare teams via a graduated scale of 0-10 The weel-being / comfort of the patient via a graduated scale of 0-10 Respect for the dignity of the patient via a graduated scale of 0-10
Time frame: [15 days]
The learning curve for using SECURIDRAP® SELFIA® by healthcare team
The curve reflects the time required for nursing expertise in the use of SECURIDRAP.
Time frame: [15 days]
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