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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 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.
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| 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 pressure injury, without pressure injury, up during the day, will ly a on a specific P-APAM (DOMUS 4 /AUTO) |
| 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:
Patient over 18 years old
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:
for adults over 70:
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Patients in nursing homes or long-stay geriatrics department
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie MEAUME, Pr | HĂ´pital ROTSCHILD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ehpad Du Parc Chateau D'Abondant | Abondant | France | ||||
| Ehpad Esbv |
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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 |
| Baugé-en-Anjou |
| France |
| Ehpad Residence Le Parc | Fontenay-aux-Roses | France |
| Ehpad Duc de Lorge | Saint-Jean-d'Illac | France |
| Ehpad Villa Du Tertre | Saint-Parres-aux-Tertres | France |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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