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

Launched by SYSTAM · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a special low-pressure motorized mattress, called the XTECH®25, can help prevent pressure ulcers (also known as bedsores) in patients who are at high risk for developing them. The study will involve adults over 18 years old who are considered at risk based on their health condition. To be eligible, participants must not have any existing pressure ulcers, must lie on the mattress for more than 20 hours a day, and have a specific score indicating their risk level.

Participants will be monitored for 35 days after starting to use the mattress, alongside standard pressure ulcer prevention measures. During this time, the study will assess how many patients develop pressure ulcers and gather feedback on their comfort, caregiver satisfaction, and the mattress's safety and noise level. This trial is taking place in nursing homes and long-term care facilities, and it aims to find better ways to protect vulnerable patients from pressure injuries. If you or a loved one may qualify, this study could provide valuable insights into enhanced care for those at risk of bedsores.

Gender

ALL

Eligibility criteria

• 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 .