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

Centre Hospitalier Universitaire de Nīmes3 sites in 1 country60 target enrollmentJune 2015

ConditionsPressure Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pressure Ulcer
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 60
Locations: 3
Primary Endpoint: Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

March 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet

Time Frame: Day 1

Secondary Outcomes

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)
Presence/absence of a pressure ulcer over the past month(1 month)