Actively Recruiting
Prevention of Pressure Ulcers in Patients at High Risk Using the Low-pressure Motorized Air Support Mattress with XTECH5 Control Unit
Led by SYSTAM · Updated on 2024-06-18
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
SYSTAM
Lead Sponsor
C
Clin-Experts
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical value of a low air pressure motorized therapeutic mattress called XTECH5 for preventing pressure injuries in patients at medium to high risk. This observational study includes patients over 18 years old who are at high risk of pressure injuries but do not currently have any. The study takes place in nursing homes and long-stay geriatrics departments, focusing on those who lie on the mattress for more than 20 hours a day. Participants will use the XTECH5 mattress along with usual pressure injury prevention measures for a follow-up period of 35 days. The mattress combines motorized and static technologies to support patients at risk. The study monitors patients continuously during this period, assessing the mattress's comfort, safety, noise level, and overall caregiver satisfaction. During the study, participants will be assessed for pressure injuries at specific body sites such as the sacrum, spine, or heel. Researchers will also collect feedback from patients, family, or staff about mattress comfort and evaluate nursing staff experiences regarding mattress use and maintenance. The main outcome is the percentage of patients developing at least one stage 2 pressure injury within 35 days, along with secondary measures like injury occurrence at other sites and mattress safety. The total participation time is 35 days after mattress installation.
CONDITIONS
Brief 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 12 or less)
- No pressure injury on the day of inclusion
- Lying more than 20 hours a day on XTECH5 mattress
- Weight less than 200 kg
- Informed consent given by patient or trusted representative
You will not qualify if you...
- End of life with estimated life expectancy under 6 months
- Expected discharge from the care facility within two months
- Malnutrition as defined by at least one phenotypic and one etiological criterion from 2021 guidelines, including significant weight loss, low BMI, or reduced muscle mass combined with inadequate nutritional intake or presence of disease causing metabolic stress
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 35 days
Participants at high risk of pressure ulcers will lie on a powered low air pressure motorized therapeutic mattress for support and prevention.
Assessments occur at day 35
Trial Site Locations
Total: 1 location
1
Multiples locations
Multiple Locations, France
Actively Recruiting
Research Team
R
Renaud URBINELLI
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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