Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area
NCT ID: NCT02735135
Last Updated: 2019-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-01-31
2019-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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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
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 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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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Annie Bauer Confort
UNKNOWN
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Emilie Viollet, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CH de Beziers
Béziers, , France
Clinique de Soins de suite et réadaptation Saint Basile
Mougins, , France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
Countries
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Other Identifiers
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2016-A00188-43
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2016/CEDMH-01
Identifier Type: -
Identifier Source: org_study_id
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