Phase
Condition
Pressure Ulcer
Treatment
Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 with a weight < 200 kg
Patient (or a trusted third party) having been informed of the study and agreeing toparticipate
Exclusion
Exclusion Criteria:
Patient at end of life (estimated life expectancy less than 6 months)
Patient discharge from the establishment expected within two months
Participants will be excluded from the study if they meet the following combinationof criteria indicative of malnutrition according to the 2021 Haute Autorité de laSanté guidelines (Participants must meet at least one phenotypic criterion and oneetiological criterion to be considered malnourished and therefore ineligible forinclusion in the study) :
A) One or more of the following phenotypic criteria:
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
Reduced Muscle Mass
Evident reduction in muscle mass AND
B) One of the following etiological criteria:
Inadequate nutritional intake:
Nutritional intake less than 50% of the energy requirements for more than one week
Reduced food intake for more than two weeks
Presence of Disease or Stress Metabolism
Acute or chronic illness, or any condition causing metabolic stress that increasesenergy requirements .
Study Design
Connect with a study center
Multiples locations
Multiple Locations,
FranceActive - Recruiting
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