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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00697-34 | Other Identifier | ANSM |
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The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Summit first) | Active Comparator | In Group 1 pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated. |
|
| Group 2 (Nimbus 3 first) | Active Comparator | In Group 2 pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summit first | Device | Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of data capture time at < 30 mmHg (%) | Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at < 30 mmHg | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean interface pressure (mmHg) | Mean interface pressure (mmHg) | Day 1 |
| Minimum interface pression (mmHg) | Minimum interface pression (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Viollet, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34598852 | Result | de Labachelerie C, Viollet E, Alonso S, Nouvel F, Bastide S, Blot M, Fagart W, Gelis A, Dupeyron A. Comparison of interface pressures in two dynamic pressure ulcer prevention supports (NIMBUS 3 and SUMMIT): A randomized controlled trial. J Tissue Viability. 2022 Feb;31(1):11-15. doi: 10.1016/j.jtv.2021.09.002. Epub 2021 Sep 11. |
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| Nimbus 3 first | Device | Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated. |
|
| Day 1 |
| Maximum interface pressure (mmHg) | Maximum interface pressure (mmHg) | Day 1 |
| Percentage of data capture time where the pressures are changing (%) | Percentage of data capture time where the pressures are changing (%) | Day 1 |
| Matress tolerance: yes/no | Tolerance of mattress: yes/no | Day 1 |