Clinical trial NCT06438042: 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
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pressure Ulcer
Keywords: Prevention
Pressure ulcer
Low air pressure motorised mattress
Lead sponsor: SYSTAM
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2024-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in nursing homes or long-stay geriatrics department

Brief summary: 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.


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 .

Primary outcomes:
measure: Percentage of patients who developed at least one stage 2 pressure injury
timeFrame: 35 days after installation on the mattress (at day 35)
Secondary outcomes:
measure: Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment of the degree of maceration
timeFrame: On a scale from 1 (constantly moist) to 4 rarely moist
measure: Assessment of mattress safety
timeFrame: At day 35
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Multiples locations
Study officials:
affiliation: Hôpital ROSCHILD
name: Sylvie MEAUME
role: PRINCIPAL_INVESTIGATOR
References: