Actively Recruiting
Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit
Led by SYSTAM · Updated on 2024-06-18
80
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
S
SYSTAM
Lead Sponsor
C
Clin-Experts
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 XTECH®25 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 XTECH®25 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.
CONDITIONS
Official Title
Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- High risk of developing pressure ulcers (clinical judgment and Braden scale score \u2264 12)
- No pressure injury at the time of inclusion
- Lying more than 20 hours a day on XTECH425 mattress
- Weight less than 200 kg
- Informed consent given by patient or trusted third party
You will not qualify if you...
- End of life with life expectancy less than 6 months
- Expected discharge from the care facility within two months
- Malnutrition based on 2021 guidelines: at least one phenotypic criterion (significant weight loss, low BMI, reduced muscle mass) AND one etiological criterion (inadequate nutritional intake or disease causing metabolic stress)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Multiples locations
Multiple Locations, France
Actively Recruiting
Research Team
R
Renaud URBINELLI
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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