Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress

Launched by NAUSICAA MEDICAL · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a special mattress called the R'GO SOINS overlay mattress can help prevent pressure ulcers (also known as bedsores) in patients who are at medium to high risk of developing them. The trial will include adults over 18 years old who are not currently suffering from any pressure injuries but spend a lot of time lying down—between 15 to 20 hours each day. Participants will be monitored for 35 days while using this mattress in nursing homes and long-term care facilities.

To be eligible for the trial, participants need to have a specific risk score for pressure ulcers, be able to give consent, and weigh less than 150 kg. However, those who are nearing the end of life, have certain spinal conditions, or have been on the mattress for too long before joining the study will not be included. During the trial, participants will share their experiences regarding comfort and satisfaction with the mattress, and the researchers will check how many develop pressure injuries during the study period. This trial aims to gather important information about this new prevention method for pressure ulcers.

Gender

ALL

Eligibility 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