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

Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: AIRSOFT DUO for 1 day; Device: SENTRY 1200 for 1 month; Device: SENTRY 1200 for 1 day; Device: AIRSOFT DUO for 1 month

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Béziers, France, 34525
    • CH de Béziers
  • Mougins, France, 06250
    • Clinique de Soins de suite et réadaptation Saint Basile
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airsoft Duo First; 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	Device: AIRSOFT DUO for 1 day; The patient is placed on an AIRSOFT DUO mattress for 1 day.; Device: SENTRY 1200 for 1 month; The patient is placed on a SENTRY 1200 mattress for 1 month.
Experimental: SENTRY 1200 First; 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	Device: SENTRY 1200 for 1 day; The patient is placed on a SENTRY 1200 mattress for 1 day.; Device: AIRSOFT DUO for 1 month; The patient is placed on an AIRSOFT DUO mattress for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak interface pressures at the sacral area (mmHg)	Day 0
Peak interface pressures at the sacral area (mmHg)	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Body contact surface area (cm^2)	Day 0
Body contact surface area (cm^2)	Day 1
Peak pressure at the heel area (mmHg)	Day 0
Peak pressure at the heel area (mmHg)	Day 1
Pressure ulcer development (yes/no)	Month 1
Self-assessment of comfort by the patient (visual analog scale)	Month 1
Self-assessment for noise (Likert scale)	Month 1
Self-assessment of sleep quality (visual analog scale)	Month 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Annie Bauer Confort
• Investigators: Study Director: Emilie Viollet, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: bedridden
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: LOCAL/2016/CEDMH-01; 2016-A00188-43 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No