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

NCT05472974 | Completed

• 1 other identifier: 2018-A01274-51
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pressure Injury

Keywords

Pressure injury; Life support system; Beds; 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

Interventions

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)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellell France: lead
• Clin-Experts: collaborator

Study Sites (5)

Ehpad Du Parc Chateau D'Abondant

Abondant, France

Location

Ehpad Esbv

Baugé-en-Anjou, France

Location

Ehpad Residence Le Parc

Fontenay-aux-Roses, France

Location

Ehpad Duc de Lorge

Saint-Jean-d'Illac, France

Location

Ehpad Villa Du Tertre

Saint-Parres-aux-Tertres, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sylvie MEAUME, Pr

  Hôpital ROTSCHILD

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: September 17, 2018
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)