Evaluation of Safe Use of SECURIDRAP® SELFIA®
Condition(s) studied
Investigational drug(s) / intervention(s)
SECURIDRAP® SELFIA®: Use of SECURIDRAP® SELFIA® for 15 night
Study 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.
Eligibility
Primary outcome measure(s)
- Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA® — [15 days]
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
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| CMMF de Bailleul | Bailleul | France | Recruiting |
| EHPAD l'Aquarelle | Bully-les-Mines | France | Recruiting |
| Centre Hospitalier d'Hazebrouck | Hazebrouck | France | Recruiting |
| Centre Hospitalier Le Quesnoy | Le Quesnoy | France | Recruiting |
| CHU Lille | Lille | France | Recruiting |
| Ussap- Asm Limoux | Limoux | France | Recruiting |
| CHU Lyon | Lyon | France | Recruiting |
| CHU Rennes | Rennes | France | Recruiting |
| CHG Roubaix | Roubaix | France | Recruiting |
| CSSR La Clauze | Saint-Jean-Delnous | France | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05510401 on ClinicalTrials.gov ↗ ← All trials in France