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

W

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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