Using a special mattress to prevent pressure ulcers in at-risk patients
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress : Observational Study
This study is testing whether a special mattress can help prevent pressure ulcers in adults at risk while they stay in nursing homes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nausicaa Medical Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06465225 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a powered alternating pressure air overlay mattress (P-APAM) in preventing pressure injuries in patients identified as medium to high risk. Participants will be adults over 18 years old who do not currently have pressure injuries and will use the mattress for 15 to 20 hours daily over a 35-day period. The study will take place in nursing homes and long-stay geriatrics departments, where patients will be monitored for the development of pressure injuries and assessed for comfort and caregiver satisfaction.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old at medium to high risk of developing pressure ulcers, as determined by clinical judgment and a Braden scale score of 10 to 14.
Not a fit: Patients who are at the end of life or have a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of pressure ulcers in vulnerable patients.
How similar studies have performed: While this study employs a specific mattress technology, similar approaches in pressure ulcer prevention have shown promise in previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Multiple Locations
- Multiples Facilities — Multiple Locations, France (Recruiting)
Study contacts
- Principal investigator: Sylvie MEAUME, PhD — Hôpital ROSCHILD
- Study coordinator: Renaud URBINELLI
- Email: etudes@clin-experts.fr
- Phone: +33756882093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.