Evaluation of Safe Use of SECURIDRAP® SELFIA® (SECURIDRAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Behavior Disorders; Disorientation
• Intervention / Treatment: Other: SECURIDRAP® SELFIA®

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline BETOUX; Phone Number: 0241637810; Email: c.betoux@mulliez-flory.fr
• Study Contact Backup: Name: Kelly LAVERGNE; Phone Number: 0231932118; Email: kelly.lavergne@evamed.fr

Study Locations

• France
  • Bailleul, France
    • Recruiting
    • CMMF de Bailleul
    • Contact: Brigitte Dr TILMONT
    • Principal Investigator: Brigitte Dr TILMONT
  • Bully-les-Mines, France
    • Recruiting
    • EHPAD l'Aquarelle
    • Contact: Valérie Dr WIEL
    • Principal Investigator: Valérie Dr WIEL
  • Hazebrouck, France
    • Recruiting
    • Centre Hospitalier d'Hazebrouck
    • Contact: Eddy Dr BAHEU
    • Principal Investigator: Eddy Dr BAHEU
    • Sub-Investigator: Annie Dr LIAGRE
  • Le Quesnoy, France
    • Recruiting
    • Centre Hospitalier Le Quesnoy
    • Contact: Denis Dr LEFEBVRE
    • Principal Investigator: Denis Dr LEFBVRE
  • Lille, France
    • Recruiting
    • CHU Lille
    • Contact: Francois Dr PUISIEUX
    • Principal Investigator: Francois Dr PUISIEUX
  • Limoux, France
    • Recruiting
    • Ussap- Asm Limoux
    • Contact: Brigitte Dr GERS
    • Principal Investigator: Brigitte Dr GERS
  • Lyon, France
    • Recruiting
    • CHU Lyon
    • Contact: Sabiha Dr AHMINE
    • Principal Investigator: Sabiha Dr AHMINE
  • Rennes, France
    • Recruiting
    • Chu Rennes
    • Contact: Aline Dr CORVOL
    • Principal Investigator: Aline Dr CORVOL
  • Roubaix, France
    • Recruiting
    • CHG Roubaix
    • Contact: Pearlide Dr Kizonzolo-de-Bello
    • Principal Investigator: Pearlide Dr Kizonzolo-de-Bello
  • Saint Jean Delnous, France
    • Recruiting
    • CSSR La Clauze
    • Contact: Philippe Dr VEAU
    • Principal Investigator: Thierry Dr LECRIQUE
    • Principal Investigator: Philippe Dr VEAU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Patient with major cognitive impairment
• Patient at risk of falling into bed
• Patient subject to guardianship or curatorship
• Patient beneficiary or affiliated to a social security scheme
• Patient who has given their participation agreement aand informed consent

Exclusion Criteria:

• 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®
• Patient with intolerance to the medical device
• Patient able to extract himself from SÉCURIDRAP® SELFIA®
• Patient able to unlock the bed rails by himself
• Patient without social coverage or not benefiting from it through a third party
• Patient minor, pregnant woman, persons deprived of their liberty
• Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SECURIDRAP® SELFIA®; Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor	Other: SECURIDRAP® SELFIA®; Use of SECURIDRAP® SELFIA® for 15 night

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate 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	[15 days]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	[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)	[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	[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.	[15 days]

Collaborators and Investigators

• Sponsor: Groupe Mulliez-Flory
• Collaborators: EVAMED
• Investigators: Principal Investigator: François Pr PUISIEUX, CHU Lille; Principal Investigator: Aline Dr CORVOL, Chu Rennes; Principal Investigator: Sabine Dr AHMINE, CHU Lyon; Principal Investigator: Thierry Dr LECRIQUE, CSSR La Clauze; Principal Investigator: Brigitte Dr GERS, Ussap- Asm Limoux; Principal Investigator: Marguerite Dr REY, Ussap- Asm Limoux; Principal Investigator: Valérie Dr WIEL, EHPAD l'Aquarelle; Principal Investigator: Brigitte Dr TILMONT, CMMF de Bailleul; Principal Investigator: Eddy Dr BAHEU, CH Hazebrouck; Principal Investigator: Denis Dr LEFEBVRE, CH Le Quesnoy; Principal Investigator: Philippe Dr VEAU, CSSR La Clauze; Principal Investigator: Pearlide Dr Kizonzolo-de-Bello, CHG Roubaix

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: disorientation; nocturnal behavioral disorders; major cognitive impairment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Mental Disorders; Confusion
• Other Study ID Numbers: 2019-A03234-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No