Evaluation of Safe Use of SECURIDRAP® SELFIA®
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Mulliez-Flory
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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®
Trial design
Design model
Single group
Treatments tested in this trial
SECURIDRAP® SELFIA®
Other interventionUse of SECURIDRAP® SELFIA® for 15 night
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: SECURIDRAP® SELFIA®Other 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
[15 days]Secondary outcomes
1
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]2
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]3
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]4
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]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Groupe Mulliez-Flory
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov