New air mattress aims to stop bedsores before they start
NCT ID NCT06465225
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at whether a powered alternating pressure air mattress can prevent pressure ulcers (bedsores) in patients at medium to high risk. 90 adults in nursing homes and long-term care used the mattress for up to 35 days. Researchers tracked how many developed at least a stage 2 bedsore on the back, spine, or heel, and also measured comfort and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- powered alternating pressure air overlay mattress
- What this could lead to
- If successful, this mattress could help prevent painful pressure ulcers in bedridden patients, reducing suffering and healthcare costs.
- What could go wrong
- This was a small, non-comparative study with only 90 participants. Without a control group, it's unclear how much better the mattress is than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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90 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients in nursing homes or long-stay geriatrics department
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient over 18 years old * Patient with a medium to high risk of developing pressure ulcers (clinical judgment and a score of \[10 to 14\] on the Braden scale (6 (maximum risk) to 23 (no risk)) * Patient without pressure injury on the day of inclusion * Patient up during the day and lying down for more than 15 hours and less than 20 hours per day on an R'GO SOINS overlay mattress for less than 48 hours or since the day of inclusion * Patient with a weight \< 150kg * Patient (or a trusted third party/legal representative) having been informed of the study and signing informed consent Exclusion Criteria: * Patient at end of life (estimated life expectancy less than 6 months) * Patient discharge from the establishment expected within two months * Patient already installed on an R'GO SOINS mattress topper for more than 48 hours before inclusion * Patient with unstable spinal injury or other spinal disorder * Patient with cervical or skeletal traction * Patient with unstable spinal cord injury * Patient with acute multiple trauma * Patient with unstable posttraumatic bone fracture * Participants will be excluded from the study if they meet the following combination of criteria indicative of malnutrition according to the 2021 French National Authority for Health guidelines (Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study) : A) One or more of the following phenotypic criteria: Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months Low Body Mass Index (BMI): BMI \< 18.5 kg/m² for individuals under 70 years old, BMI \< 21 kg/m² for individuals aged 70 years and older Reduced Muscle Mass Evident reduction in muscle mass AND B) One of the following etiological criteria: Inadequate nutritional intake: Nutritional intake less than 50% of the energy requirements for more than one week Reduced food intake for more than two weeks Presence of Disease or Stress Metabolism Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Multiples Facilities
Multiple Locations, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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