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| Name | Class |
|---|---|
| Clin-Experts | INDUSTRY |
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The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay 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 between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.
Patients will be 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 will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in nursing homes or long-stay geriatrics department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a powered alternating pressure air mattress | Device | Patients with a medium to high risk of developing pressure injury, without pressure injury, up during the day and lying between 15 and 20 hours per day will ly a on a R'GO Soins overlay mattress |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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 increases energy requirements
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Patients in nursing homes or long-stay geriatrics department
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie MEAUME, PhD | Hôpital ROSCHILD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiples Facilities | Multiple Locations | France |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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 |