Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area

Not Applicable

Withdrawn

• Conditions: Pressure Ulcer

• Registration Number: NCT02735135
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-12
• Study Start: 2019-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25
• Primary Completion: 2019-07
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peak interface pressures at the sacral area (mmHg)	Day 1

Secondary Outcome Measures

Name	Time	Method
Self-assessment for noise (Likert scale)	Month 1
Self-assessment of sleep quality (visual analog scale)	Month 1
Pressure ulcer development (yes/no)	Month 1
Self-assessment of comfort by the patient (visual analog scale)	Month 1
Body contact surface area (cm^2)	Day 1
Peak pressure at the heel area (mmHg)	Day 1

Trial Locations

Locations (3)

CH de Beziers; 🇫🇷 Béziers, France

Clinique de Soins de suite et réadaptation Saint Basile; 🇫🇷 Mougins, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France