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

SYSTAM

Status: Enrolling

Conditions: Pressure Ulcer

Treatments: Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies

Study type: Observational

Funder types: Industry

Identifiers

NCT06438042

2023-A01556-39

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 to participate

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 combination of criteria indicative of malnutrition according to the 2021 Haute Autorité de la Santé guidelines (Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study) :

A) One or more of the following phenotypic criteria:

1. Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months
2. 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
3. Reduced Muscle Mass
4. Evident reduction in muscle mass AND

B) One of the following etiological criteria:

1. Inadequate nutritional intake:
2. Nutritional intake less than 50% of the energy requirements for more than one week
3. Reduced food intake for more than two weeks
4. Presence of Disease or Stress Metabolism
5. Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements .

Trial design

80 participants in 1 patient group

Patients in nursing homes or long-stay geriatrics department

Treatment:

Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies