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

Not Applicable

Completed

• Conditions: Pressure Ulcer

• Registration Number: NCT02380820
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Study Start: 2015-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Patient-rated comfort as measured by the visual analog scale	1 month	Visual analog scale ranging from 0 to 10
Presence/absence of a pressure ulcer over the past month	1 month

Trial Locations

Locations (3)

EHPAD La Chimotaie; 🇫🇷 Cugan Montaigu Cedex, France

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

EHPAD Notre Dame des Pins; 🇫🇷 Saint Privat des Vieux, France