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

Pressure Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05472974
• Other study ID #: 2018-A01274-51
• Status: Completed
• Start date: September 17, 2018
• Est. completion date: July 22, 2019

Study information

• Verified date: July 2022
• Source: Wellell France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Ulcer

Intervention

Device:
• Use of a powered alternating pressure air mattress
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)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Wellell France	Clin-Experts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Assessment of mattress safety	by collecting any adverse event or mattress malfunction during the follow up	At day 35