Clinical trial NCT02380820: Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
Official title: Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Mattress
Preventing bed sores
Skin pressure
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Invacare Poirier S.A.S.
First posted: 2015-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: 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 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).

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 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

Primary outcomes:
measure: Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet
timeFrame: Day 1
Secondary outcomes:
measure: Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet
timeFrame: Day 1
measure: Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet
timeFrame: Day 1
measure: Presence/absence of a pressure ulcer over the past month
timeFrame: 1 month
measure: Patient-rated comfort as measured by the visual analog scale
timeFrame: 1 month
Other outcomes:
measure: Age (years)
timeFrame: Baseline (Day 0)
measure: Sex (F/M)
timeFrame: Baseline (Day 0)
measure: Weight (kg)
timeFrame: Baseline (Day 0)
measure: Height (cm)
timeFrame: Baseline (Day 0)
measure: Body mass index (kg/m^2)
timeFrame: Baseline (Day 0)
measure: Norton risk score
timeFrame: Baseline (Day 0)
measure: Albuminemia
timeFrame: Baseline (Day 0)
Locations:
city: Cugan Montaigu Cedex
country: France
facility: EHPAD La Chimotaie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Saint Privat des Vieux
country: France
facility: EHPAD Notre Dame des Pins
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Emilie Viollet, MD
role: PRINCIPAL_INVESTIGATOR
References: