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.
Patient over 18 years old
Patient with high risk of developing pressure ulcers (clinical judgment and a score <= 12 on the Braden scale (6 (maximum risk) to 23 (no risk))
Patient without pressure injury on the day of inclusion
Patient up lying more than 20 hours a day on XTECH®25 mattress
Patient at end of life (estimated life expectancy less than 6 months)
Patient discharge from the establishment expected within two months
Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months
Low Body Mass Index (BMI): BMI < 18.5 kg/m² for individuals under 70 years old, BMI < 21 kg/m² for individuals aged 70 years and older
Patients in nursing homes or long-stay geriatrics department
Cohort
Prospective
Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
DevicePatients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 mattress
Percentage of patients who developed at least one stage 2 pressure injury
Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)
Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between
Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)
On a scale from 0 (not satisfied at all) to 4 (very satisfied)
Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)
On a scale from 0 (not satisfied at all) to 4 (very satisfied)
Assessment of the degree of maceration
On a scale from 1 (constantly moist) to 4 rarely moist
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SYSTAM
Lead sponsor
Clin-Experts
Collaborator
