Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress

Study Overview
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Brief Summary
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The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) 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 medium to high risk of PI, without PI, up during the day, and lying more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the P-APAM 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.

Official Title
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Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress: Non-interventional Study

Conditions
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Pressure Injury

Intervention / Treatment
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* Device: Use of a powered alternating pressure air mattress


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old Patient with a medium to high risk of developing pressure ulcers (clinical judgment and a score of [10 to 14] on the Braden scale (6 (maximum risk) to 23 (no risk)) Patient without pressure injury on the day of inclusion Patient up during the day, lying between 3 p.m. and 8 p.m. a day on a Domus 4 / AUTO 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) Malnourished patient according to the french health authority (Haute Autorité de la santé) definition* * For adults under 70: weight loss ≥ 5% in one month or ≥ 10% in six months or body mass index (BMI) ≤ 18.5 (excluding constitutional thinness) for adults over 70: weight loss ≥ 5% in one month or ≥ 10% in six months or BMI ≤ 21 or Mini Nutritional Assessment (MNA) ≤ 17 (/30) or albuminemia < 35 g/L

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Use of a powered alternating pressure air mattress|Patients with a medium to high risk of pressure injury, without pressure injury, up during the day, will ly a on a specific P-APAM (DOMUS 4 /AUTO)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 35 days after installation on the mattress (at day 35) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between |  | 35 days after installation on the mattress (at day 35) | 
| 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) | 35 days after installation on the mattress (at day 35) | 
| 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) | 35 days after installation on the mattress (at day 35) | 
| Assessment of the degree of maceration | On a scale from 1 (constantly moist) to 4 rarely moist | 35 days after installation on the mattress (at day 35) | 
| Assessment of mattress safety | by collecting any adverse event or mattress malfunction during the follow up | At day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure injury, Life support system, Beds, Prevention