- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02735135
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
Study Overview
Status
Conditions
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Béziers, France, 34525
- CH de Béziers
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Mougins, France, 06250
- Clinique de Soins de suite et réadaptation Saint Basile
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Nîmes Cedex 09, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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 |
The patient is placed on an AIRSOFT DUO mattress for 1 day.
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 |
The patient is placed on a SENTRY 1200 mattress for 1 day.
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)
Time Frame: Day 0
|
Day 0
|
Peak interface pressures at the sacral area (mmHg)
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body contact surface area (cm^2)
Time Frame: Day 0
|
Day 0
|
Body contact surface area (cm^2)
Time Frame: Day 1
|
Day 1
|
Peak pressure at the heel area (mmHg)
Time Frame: Day 0
|
Day 0
|
Peak pressure at the heel area (mmHg)
Time Frame: Day 1
|
Day 1
|
Pressure ulcer development (yes/no)
Time Frame: Month 1
|
Month 1
|
Self-assessment of comfort by the patient (visual analog scale)
Time Frame: Month 1
|
Month 1
|
Self-assessment for noise (Likert scale)
Time Frame: Month 1
|
Month 1
|
Self-assessment of sleep quality (visual analog scale)
Time Frame: Month 1
|
Month 1
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Emilie Viollet, MD, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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