Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Injury
Keywords: Pressure injury
Life support system
Beds
Prevention
Lead sponsor: Wellell France
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2022-07-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in nursing homes or long-stay geriatrics department

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.


Eligibility criteria: 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

Primary outcomes:
measure: percentage of patients who developed at least one stage 2 pressure injury
timeFrame: 35 days after installation on the mattress (at day 35)
Secondary outcomes:
measure: Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment of the degree of maceration
timeFrame: 35 days after installation on the mattress (at day 35)
measure: Assessment of mattress safety
timeFrame: At day 35
Other outcomes:
Locations:
city: Abondant
country: France
facility: Ehpad Du Parc Chateau D'Abondant
city: Bauge En Anjou
country: France
facility: Ehpad Esbv
city: Fontenay-aux-Roses
country: France
facility: Ehpad Residence Le Parc
city: Saint-Jean-d'Illac
country: France
facility: Ehpad Duc de Lorge
city: Saint-Parres-aux-Tertres
country: France
facility: Ehpad Villa Du Tertre
Study officials:
affiliation: Hôpital ROTSCHILD
name: Sylvie MEAUME, Pr
role: PRINCIPAL_INVESTIGATOR
References: