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Evaluation of Safe Use of SECURIDRAP® SELFIA®

NCT05510401 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-11-20

No results posted yet for this 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.

Conditions

Interventions

OTHER

SECURIDRAP® SELFIA®

Use of SECURIDRAP® SELFIA® for 15 night

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Groupe Mulliez-Flory

    lead INDUSTRY

Principal Investigators

  • François Pr PUISIEUX · CHU Lille

  • Aline Dr CORVOL · CHU Rennes

  • Sabine Dr AHMINE · Hospices Civils de Lyon

  • Thierry Dr LECRIQUE · CSSR La Clauze

  • Brigitte Dr GERS · USSAP- ASM LIMOUX

  • Marguerite Dr REY · USSAP- ASM LIMOUX

  • Valérie Dr WIEL · EHPAD l'Aquarelle

  • Brigitte Dr TILMONT · CMMF de Bailleul

  • Eddy Dr BAHEU · CH Hazebrouck

  • Denis Dr LEFEBVRE · CH Le Quesnoy

  • Philippe Dr VEAU · CSSR La Clauze

  • Pearlide Dr Kizonzolo-de-Bello · CHG Roubaix

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2025-03-30
Completion
2025-07-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510401 on ClinicalTrials.gov