Trials / Withdrawn
WithdrawnNCT02735135
Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area
Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak 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. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AIRSOFT DUO for 1 day | The patient is placed on an AIRSOFT DUO mattress for 1 day. |
| DEVICE | SENTRY 1200 for 1 month | The patient is placed on a SENTRY 1200 mattress for 1 month. |
| DEVICE | SENTRY 1200 for 1 day | The patient is placed on a SENTRY 1200 mattress for 1 day. |
| DEVICE | AIRSOFT DUO for 1 month | The patient is placed on an AIRSOFT DUO mattress for 1 month. |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2019-07-01
- Completion
- 2019-08-01
- First posted
- 2016-04-12
- Last updated
- 2019-04-25
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02735135. Inclusion in this directory is not an endorsement.