Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area (SPA2-ARSFT-DUO)

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Pressure Ulcer

Treatments: Device: SENTRY 1200 for 1 day; Device: AIRSOFT DUO for 1 day; Device: AIRSOFT DUO for 1 month; Device: SENTRY 1200 for 1 month

Study type: Interventional

Funder types: Other

Identifiers

NCT02735135

2016-A00188-43 (Other Identifier)

LOCAL/2016/CEDMH-01

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Airsoft Duo First

Experimental group

Description:

Patients randomized to this arm will be placed on an AIRSOFT DUO mattress for day 0. They will then be switched to a SENTRY 1200 mattress until the end of month 1. Intervention: AIRSOFT DUO for 1 day Intervention: SENTRY 1200 for 1 month

Treatment:

Device: AIRSOFT DUO for 1 day

Device: SENTRY 1200 for 1 month

SENTRY 1200 First

Experimental group

Description:

Patients randomized to this arm will be placed on a SENTRY 1200 mattress for day 0. They will then be switched to an AIRSOFT DUO mattress until the end of month 1. Intervention: SENTRY 1200 for 1 day Intervention: AIRSOFT DUO for 1 month

Treatment:

Device: SENTRY 1200 for 1 day

Device: AIRSOFT DUO for 1 month