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Completed

NCT Number: NCT05472974

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

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.

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Key information

Conditions

Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ehpad Du Parc Chateau D'Abondant, Abondant, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of a powered alternating pressure air mattress

Device

Patients with a medium to high risk of pressure injury, without pressure injury, up during the day, will ly a on a specific P-APAM (DOMUS 4 /AUTO)

Primary outcomes

  1. percentage of patients who developed at least one stage 2 pressure injury

    Time frame: 35 days after installation on the mattress (at day 35)

    Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)

Secondary outcomes

  1. Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between

    Time frame: 35 days after installation on the mattress (at day 35)

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

    Time frame: 35 days after installation on the mattress (at day 35)

    On a scale from 0 (not satisfied at all) to 4 (very satisfied)

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

    Time frame: 35 days after installation on the mattress (at day 35)

    On a scale from 0 (not satisfied at all) to 4 (very satisfied)

  4. Assessment of the degree of maceration

    Time frame: 35 days after installation on the mattress (at day 35)

    On a scale from 1 (constantly moist) to 4 rarely moist

  5. Assessment of mattress safety

    Time frame: At day 35

    by collecting any adverse event or mattress malfunction during the follow up

Sponsors and collaborators

Lead sponsor

Wellell France

Industry

Collaborators

  • Clin-Experts

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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