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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Wellell France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-07-22
• Completion: 2019-07-22
• First posted: 2022-07-25
• Last updated: 2022-07-26

Locations

5 sites across 1 country: France