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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01214-43 | Other Identifier | RCB number |
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| Name | Class |
|---|---|
| Invacare Poirier S.A.S. | UNKNOWN |
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The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.
The secondary objectives of the study are to compare the two devices in terms of:
A. contact surface. B. heel pressure. C. On the occurrence of pressure ulcers anywhere on the body at month 1. D. patient comfort after 1 month (visual analog scale ranging from 1 to 10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirsoftDuo first | Experimental | Patients randomized to this arm will be placed on the Airsoft Duo mattress, and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Softform Premium mattress (in static mode). The patient will then continue his/her stay with the Softform Premium mattress (in static mode) for 1 month. Intervention: Airsoft Duo mattress Intervention: Softform Premier mattress (in static mode) |
|
| Softform Premium first | Experimental | Patients randomized to this arm will be placed on the Softform Premium mattress (in static mode), and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Airsoft Duo mattress. The patient will then continue his/her stay with the Airsoft Duo mattress for 1 month. Intervention: Softform Premier mattress (in static mode) Intervention: Airsoft Duo mattress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airsoft Duo mattress | Device | A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet | Day 1 | |
| Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet | Day 1 | |
| Measure | Description | Time Frame |
|---|---|---|
| Age (years) | Baseline (Day 0) | |
| Sex (F/M) | Baseline (Day 0) | |
| Weight (kg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Viollet, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EHPAD La Chimotaie | Cugan Montaigu Cedex | 85610 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
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| Softform Premier mattress (in static mode) | Device | A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom). |
|
| Presence/absence of a pressure ulcer over the past month |
| 1 month |
| Patient-rated comfort as measured by the visual analog scale | Visual analog scale ranging from 0 to 10 | 1 month |
| Baseline (Day 0) |
| Height (cm) | Baseline (Day 0) |
| Body mass index (kg/m^2) | Baseline (Day 0) |
| Norton risk score | Baseline (Day 0) |
| Albuminemia | Baseline (Day 0) |
| Nîmes |
| 30029 |
| France |
| EHPAD Notre Dame des Pins | Saint-Privat-des-Vieux | 30340 | France |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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