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

The research company Groupe Mulliez-Flory is conducting the clinical trial Evaluation of Safe Use of SECURIDRAP® SELFIA® (SECURIDRAP).

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.

It is planned to include 108 participants.

Actual study start date is May 18, 2022. The researchers expect to complete the study by December 31, 2022.

One primary outcome measure is 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.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05510401.