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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 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.
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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 low air pressure motorised therapeutic mattress that combines the motorised and static technologies | Device | Patients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 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:
B) One of the following etiological criteria:
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Patients in nursing homes or long-stay geriatrics department
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renaud URBINELLI | Contact | 0756882093 | contact@clin-experts.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sylvie MEAUME | Hôpital ROSCHILD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiples locations | Recruiting | Multiple Locations | France |
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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 | On a scale from 1 (constantly moist) to 4 rarely moist |
| Assessment of mattress safety | By collecting any adverse event or mattress malfunction during the follow up | At day 35 |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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