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

Pressure Ulcer Clinical Trial

— SPA2-ARSFT-DUO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02735135
• Other study ID #: LOCAL/2016/CEDMH-01
• Secondary ID: 2016-A00188-43
• Status: Withdrawn
• Phase: N/A
• Start date: January 2019
• Est. completion date: August 2019

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Device:
• AIRSOFT DUO for 1 day
The patient is placed on an AIRSOFT DUO mattress for 1 day.
• SENTRY 1200 for 1 month
The patient is placed on a SENTRY 1200 mattress for 1 month.
• SENTRY 1200 for 1 day
The patient is placed on a SENTRY 1200 mattress for 1 day.
• AIRSOFT DUO for 1 month
The patient is placed on an AIRSOFT DUO mattress for 1 month.

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Annie Bauer Confort

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak interface pressures at the sacral area (mmHg)		Day 0
Primary	Peak interface pressures at the sacral area (mmHg)		Day 1
Secondary	Body contact surface area (cm^2)		Day 0
Secondary	Body contact surface area (cm^2)		Day 1
Secondary	Peak pressure at the heel area (mmHg)		Day 0
Secondary	Peak pressure at the heel area (mmHg)		Day 1
Secondary	Pressure ulcer development (yes/no)		Month 1
Secondary	Self-assessment of comfort by the patient (visual analog scale)		Month 1
Secondary	Self-assessment for noise (Likert scale)		Month 1
Secondary	Self-assessment of sleep quality (visual analog scale)		Month 1