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

Sponsor

Wellell France (Industry)

Overall Status

Completed

CT.gov ID

NCT05472974

Collaborator

Clin-Experts (Industry)

Enrollment

Locations

10.1

Actual Duration (Months)

17.2

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Injury	Device: Use of a powered alternating pressure air mattress

Study Design

Study Type:

Observational

Actual Enrollment :

86 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 17, 2018

Actual Primary Completion Date :

Jul 22, 2019

Actual Study Completion Date :

Jul 22, 2019

Outcome Measures

Primary Outcome Measures

percentage of patients who developed at least one stage 2 pressure injury [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 Outcome Measures

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)]
On a scale from 0 (not satisfied at all) to 4 (very satisfied)
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)]
On a scale from 0 (not satisfied at all) to 4 (very satisfied)
Assessment of the degree of maceration [35 days after installation on the mattress (at day 35)]
On a scale from 1 (constantly moist) to 4 rarely moist
Assessment of mattress safety [At day 35]
by collecting any adverse event or mattress malfunction during the follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Ehpad Du Parc Chateau D'Abondant	Abondant	France
2	Ehpad Esbv	Bauge En Anjou	France
3	Ehpad Residence Le Parc	Fontenay-aux-Roses	France
4	Ehpad Duc de Lorge	Saint-Jean-d'Illac	France
5	Ehpad Villa Du Tertre	Saint-Parres-aux-Tertres	France