Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo (SPA2-INVACARE)

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Airsoft Duo mattress; Device: Softform Premier mattress (in static mode)

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cugan Montaigu Cedex, France, 85610
    • EHPAD La Chimotaie
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Saint Privat des Vieux, France, 30340
    • EHPAD Notre Dame des Pins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AirsoftDuo first; Patients randomized to this arm will be placed on the Airsoft Duo mattress, and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Softform Premium mattress (in static mode). The patient will then continue his/her stay with the Softform Premium mattress (in static mode) for 1 month. Intervention: Airsoft Duo mattress Intervention: Softform Premier mattress (in static mode)	Device: Airsoft Duo mattress; A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).; Device: Softform Premier mattress (in static mode); A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).
Experimental: Softform Premium first; Patients randomized to this arm will be placed on the Softform Premium mattress (in static mode), and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Airsoft Duo mattress. The patient will then continue his/her stay with the Airsoft Duo mattress for 1 month. Intervention: Softform Premier mattress (in static mode) Intervention: Airsoft Duo mattress	Device: Airsoft Duo mattress; A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).; Device: Softform Premier mattress (in static mode); A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visual analog scale ranging from 0 to 10	1 month

Other Outcome Measures

Outcome Measure	Time Frame
Age (years)	Baseline (Day 0)
Body mass index (kg/m^2)	Baseline (Day 0)
Sex (F/M)	Baseline (Day 0)
Weight (kg)	Baseline (Day 0)
Height (cm)	Baseline (Day 0)
Norton risk score	Baseline (Day 0)
Albuminemia	Baseline (Day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Invacare Poirier S.A.S.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: April 8, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Mattress; Preventing bed sores; Skin pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: LOCAL/2014/CEDMH-01; 2014-A01214-43 (Other Identifier: RCB number)