Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465225
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the RGO SOINS Overlay Mattress
Sponsor:
Nausicaa Medical
Organization:
Nausicaa Medical
Study Overview
Official Title:
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the RGO SOINS Overlay Mattress Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESERVE
Brief Summary:
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress P-APAM in the prevention of pressure injury PI in patients at medium to high risk
This study is noncomparative observational study
Patients older than 18 years of age with a medium to high risk of PI without PI up during the day and lying between 15 and 20 hours per day on a specific P-APAM will be included The study will be conducted in nursing homes and in long-stay geriatrics department
Patients will be followed up for 35 days The use of the P-APAM is associated with the usual PI prevention measures The primary outcome is the percentage of patients who will develop at least one PI of at least stage 2 on the sacrum spine or heel between day 0 and day 35 Secondary endpoints are patient assessments of comfort caregiver satisfaction mattress noise level and mattress safety
This study is noncomparative observational study
Patients older than 18 years of age with a medium to high risk of PI without PI up during the day and lying between 15 and 20 hours per day on a specific P-APAM will be included The study will be conducted in nursing homes and in long-stay geriatrics department
Patients will be followed up for 35 days The use of the P-APAM is associated with the usual PI prevention measures The primary outcome is the percentage of patients who will develop at least one PI of at least stage 2 on the sacrum spine or heel between day 0 and day 35 Secondary endpoints are patient assessments of comfort caregiver satisfaction mattress noise level and mattress safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None