Clinical trial NCT02735135: Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pressure Ulcer
Keywords: bedridden
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Annie Bauer Confort
First posted: 2016-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Peak interface pressures at the sacral area (mmHg)
timeFrame: Day 0
measure: Peak interface pressures at the sacral area (mmHg)
timeFrame: Day 1
Secondary outcomes:
measure: Body contact surface area (cm^2)
timeFrame: Day 0
measure: Body contact surface area (cm^2)
timeFrame: Day 1
measure: Peak pressure at the heel area (mmHg)
timeFrame: Day 0
measure: Peak pressure at the heel area (mmHg)
timeFrame: Day 1
measure: Pressure ulcer development (yes/no)
timeFrame: Month 1
measure: Self-assessment of comfort by the patient (visual analog scale)
timeFrame: Month 1
measure: Self-assessment for noise (Likert scale)
timeFrame: Month 1
measure: Self-assessment of sleep quality (visual analog scale)
timeFrame: Month 1
Other outcomes:
Locations:
city: Béziers
country: France
facility: CH de Beziers
city: Mougins
country: France
facility: Clinique de Soins de suite et réadaptation Saint Basile
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Emilie Viollet, MD
role: STUDY_DIRECTOR
References: