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New air mattress aims to stop bedsores before they start

NCT ID NCT06465225

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

90 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Multiples Facilities

    Multiple Locations, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.