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

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Injury
• Intervention / Treatment: Device: Use of a powered alternating pressure air mattress

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• France
  • Abondant, France
    • Ehpad Du Parc Chateau D'Abondant
  • Bauge En Anjou, France
    • Ehpad Esbv
  • Fontenay-aux-Roses, France
    • Ehpad Residence Le Parc
  • Saint-Jean-d'Illac, France
    • Ehpad Duc de Lorge
  • Saint-Parres-aux-Tertres, France
    • Ehpad Villa Du Tertre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in nursing homes or long-stay geriatrics department

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	On a scale from 0 (not satisfied at all) to 4 (very satisfied)	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)	On a scale from 0 (not satisfied at all) to 4 (very satisfied)	35 days after installation on the mattress (at day 35)
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)
Assessment of mattress safety	by collecting any adverse event or mattress malfunction during the follow up	At day 35

Collaborators and Investigators

• Sponsor: Wellell France
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Sylvie MEAUME, Pr, Hôpital Rotschild

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2018
• Primary Completion (ACTUAL): July 22, 2019
• Study Completion (ACTUAL): July 22, 2019

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (ACTUAL): July 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 23, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Pressure injury; Life support system; Beds
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Skin Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: 2018-A01274-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No