Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress

Wellell

Status: Completed

Conditions: Pressure Injury

Treatments: Device: Use of a powered alternating pressure air mattress

Study type: Observational

Funder types: Industry

Identifiers

NCT05472974

2018-A01274-51

Details and patient eligibility

About

The aim of the study is to determine the clinical value of using a powered alternating pressure air 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 more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department.

Patients are 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 developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, lying between 3 p.m. and 8 p.m. a day on a Domus 4 / AUTO mattress
• Patient with a weight < 200 kg
• Patient (or a trusted third party) having been informed of the study and agreeing to participate

Exclusion criteria

• Patient at end of life (estimated life expectancy less than 6 months)

• Malnourished patient according to the french health authority (Haute Autorité de la santé) definition*

  * For adults under 70:

  • weight loss ≥ 5% in one month or ≥ 10% in six months
  • or body mass index (BMI) ≤ 18.5 (excluding constitutional thinness)

• for adults over 70:

  • weight loss ≥ 5% in one month or ≥ 10% in six months
  • or BMI ≤ 21
  • or Mini Nutritional Assessment (MNA) ≤ 17 (/30)
  • or albuminemia < 35 g/L