Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438042
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-26
Brief Title:
Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH25 Control Unit
Sponsor:
SYSTAM
Organization:
SYSTAM
Study Overview
Official Title:
Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH25 Control Unit
Status:
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:
None
Brief Summary:
The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress 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 high risk of PI without PI lying more than 20 hours a day on a XTECH25 mattress will be included The study will be conducted in nursing homes and in long-stay geriatrics department
Patients are followed up for 35 days The use of the XTECH25 mattress is associated with the usual PI prevention measures The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum spine or heel 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 high risk of PI without PI lying more than 20 hours a day on a XTECH25 mattress will be included The study will be conducted in nursing homes and in long-stay geriatrics department
Patients are followed up for 35 days The use of the XTECH25 mattress is associated with the usual PI prevention measures The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum spine or heel 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