Trials / Completed
CompletedNCT02380820
Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Airsoft Duo mattress | A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany). |
| DEVICE | Softform Premier mattress (in static mode) | A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom). |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2015-03-05
- Last updated
- 2016-04-11
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02380820. Inclusion in this directory is not an endorsement.