An interventional study of Airsoft Duo mattress and Softform Premier mattress (in static mode) in Pressure Ulcer, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 3 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-04-11.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Prevention
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.
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).
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: Softform Premier mattress (in static mode)
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 · Device: Softform Premier mattress (in static mode)
A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).
A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).
Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet
Time frame: Day 1
Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet
Time frame: Day 1
Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet
Time frame: Day 1
Presence/absence of a pressure ulcer over the past month
Time frame: 1 month
Patient-rated comfort as measured by the visual analog scale
Visual analog scale ranging from 0 to 10
Time frame: 1 month
Age (years)
Time frame: Baseline (Day 0)
Sex (F/M)
Time frame: Baseline (Day 0)
Weight (kg)
Time frame: Baseline (Day 0)
Height (cm)
Time frame: Baseline (Day 0)
Body mass index (kg/m^2)
Time frame: Baseline (Day 0)
Norton risk score
Time frame: Baseline (Day 0)
Albuminemia
Time frame: Baseline (Day 0)
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes