Pressure Ulcer
Conditions
Keywords
Mattress, Preventing bed sores, Skin pressure
Brief 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).
Interventions
DEVICEAirsoft Duo mattress
A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).
DEVICESoftform Premier mattress (in static mode)
A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).
Sponsors
Invacare Poirier S.A.S.
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient spends more than 12 hours in bed with a possible verticalization and a predictable length of stay of at least 1 month. * The patient has a stable medical condition (no complications in the last 10 days) without pressure ulcers * The patient is at risk of pressure ulcers assessed a score ≤ 14 on the Norton scale * The patient's weight is less than 120 Kg
Exclusion criteria
* The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Contra-indication for strict decubitus dorsal position * The patient has a rotation of the pelvis, asymmetric deformations of the hips in the frontal plane. * The patient has bedsores, a recent scar in a pressure area. * The patient has a knee flexion deformity\> 10 ° * The patient is agitated or uncooperative * The patient's weight is greater than 120 Kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Presence/absence of a pressure ulcer over the past month | 1 month | — |
| Patient-rated comfort as measured by the visual analog scale | 1 month | Visual analog scale ranging from 0 to 10 |
Other
| Measure | Time frame |
|---|---|
| Norton risk score | Baseline (Day 0) |
| Age (years) | Baseline (Day 0) |
| Albuminemia | Baseline (Day 0) |
| Sex (F/M) | Baseline (Day 0) |
| Weight (kg) | Baseline (Day 0) |
| Height (cm) | Baseline (Day 0) |
| Body mass index (kg/m^2) | Baseline (Day 0) |
Countries
France
Outcome results
None listed