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

NCT06465225 | Completed

• 1 other identifier: 2023-A02335-40
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer

Keywords

automated decompression air mattress; pressure ulcer; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)

  35 days after installation on the mattress (at day 35)

• Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)

  35 days after installation on the mattress (at day 35)

• Assessment of the degree of maceration

  35 days after installation on the mattress (at day 35)

• Assessment of mattress safety

  At day 35

Study Arms (1)

Patients in nursing homes or long-stay geriatrics department

Device: Use of a powered alternating pressure air mattress

Interventions

Use of a powered alternating pressure air mattress DEVICE

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

Patients in nursing homes or long-stay geriatrics department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in nursing homes or long-stay geriatrics department

You may qualify if:

• 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 with a weight \< 150kg
• Patient (or a trusted third party/legal representative) having been informed of the study and signing informed consent

You may not qualify if:

• Patient at end of life (estimated life expectancy less than 6 months)
• Patient discharge from the establishment expected within two months
• 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
• 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

Sponsors & Collaborators

• Nausicaa Medical: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiples Facilities

Multiple Locations, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sylvie MEAUME, PhD

  Hôpital ROSCHILD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 17, 2024
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)