Multicenter Study to Confirm the Safe Use of SECURIDRAP4 SELFIA4 Bedding in Patients with Cognitive and Behavioral Disorders

What this Trial Is About

Researchers are evaluating the safety of the SECURIDRAP4 SELFIA4 bedding system in adults with disorientation, cognitive impairment, or behavior disorders. This interventional, multicenter, prospective, and non-comparative clinical investigation takes place in nursing homes and hospitals in France. It was initiated following the market withdrawal of the first version of the product and is conducted to confirm the safety of the second version as recommended by the ASNM. Participants will use the SECURIDRAP4 SELFIA4 restraint system for 15 consecutive nights as part of their usual care. An independent assessor will monitor the proper use of the bedding system during this period to ensure compliance with safety conditions. The study focuses on adverse events linked to the product, user errors, patient bedridden status, healthcare team satisfaction, and the learning curve for proper use. During the 15-night follow-up, patients will be closely observed, and data on adverse events and user-related safety issues will be collected. Healthcare teams will provide feedback on time savings, comfort, well-being, and respect for patient dignity. The study tracks the rate of patients remaining bedridden each night and monitors the staffs ability to learn the proper use of the SECURIDRAP4 SELFIA4 system. The total participation duration is 15 nights with minimal risks and constraints.

Evaluation of Safe Use of SECURIDRAP® SELFIA®