Pressure Ulcer
Conditions
Keywords
bedridden
Brief 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).
Interventions
DEVICEAIRSOFT DUO for 1 day
The patient is placed on an AIRSOFT DUO mattress for 1 day.
DEVICESENTRY 1200 for 1 month
The patient is placed on a SENTRY 1200 mattress for 1 month.
DEVICESENTRY 1200 for 1 day
The patient is placed on a SENTRY 1200 mattress for 1 day.
DEVICEAIRSOFT DUO for 1 month
The patient is placed on an AIRSOFT DUO mattress for 1 month.
Sponsors
Annie Bauer Confort
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 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 and verticalisation is possible * The patient has a stable medical condition (no complication in the last 10 days) and no visible pressure ulcers * The patient is at risk for pressure ulcers as assessed by a score ≤ 15 on the Braden Scale * The patient weighs 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 * The subject has a contra-indication for a strictly supine position * The patient has a knee flexion deformity \> 10 ° * The patient is in a state of agitation or refuses to cooperate * The patient's weight is greater than 120 Kg * The length of stay is less than one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak interface pressures at the sacral area (mmHg) | Day 0 |
Secondary
| Measure | Time frame |
|---|---|
| Peak pressure at the heel area (mmHg) | Day 0 |
| Pressure ulcer development (yes/no) | Month 1 |
| Body contact surface area (cm^2) | Day 0 |
| Self-assessment for noise (Likert scale) | Month 1 |
| Self-assessment of sleep quality (visual analog scale) | Month 1 |
| Self-assessment of comfort by the patient (visual analog scale) | Month 1 |
Countries
France
Outcome results
None listed