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

Pressure Ulcer Clinical Trial

— PRESERVE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465225
• Other study ID #: 2023-A02335-40
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Nausicaa Medical
• Contact: Renaud URBINELLI
• Phone: +33756882093
• Email: etudes[@]clin-experts.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.

This study is noncomparative, observational study.

Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.

Patients will be followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Haute Autorité de la Santé 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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Use of a powered alternating pressure air mattress
Patients with a medium to high risk of developing pressure injury, without pressure injury, up during the day and lying between 15 and 20 hours per day will ly a on a R'GO Soins overlay mattress

Locations

Country	Name	City	State
France	Multiples Facilities	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Nausicaa Medical	Clin-Experts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who developed at least one stage 2 pressure injury	Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)	35 days after installation on the mattress (at day 35)
Secondary	Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between		35 days after installation on the mattress (at day 35)
Secondary	Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)	On a scale from 0 (not satisfied at all) to 4 (very satisfied)	35 days after installation on the mattress (at day 35)
Secondary	Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)	On a scale from 0 (not satisfied at all) to 4 (very satisfied)	35 days after installation on the mattress (at day 35)
Secondary	Assessment of the degree of maceration	On a scale from 1 (constantly moist) to 4 (rarely moist)	35 days after installation on the mattress (at day 35)
Secondary	Assessment of mattress safety	By collecting any adverse event or mattress malfunction during the follow up	At day 35