Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress 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 high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.

Patients are followed up for 35 days. The use of the XTECH®25 mattress 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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Renaud URBINELLI; Phone Number: 0756882093; Email: contact@clin-experts.fr

Study Locations

• France
  • Multiple Locations, France
    • Recruiting
    • Multiples locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in nursing homes or long-stay geriatrics department

Description

Inclusion Criteria:

• Patient over 18 years old
• Patient with high risk of developing pressure ulcers (clinical judgment and a score <= 12 on the Braden scale (6 (maximum risk) to 23 (no risk))
• Patient without pressure injury on the day of inclusion
• Patient up lying more than 20 hours a day on XTECH®25 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)
• Patient discharge from the establishment expected within two months
• Participants will be excluded from the study if they meet the following combination of criteria indicative of malnutrition according to the 2021 Haute Autorité de la Santé guidelines (Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study) :

A) One or more of the following phenotypic criteria:

1. Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months
2. Low Body Mass Index (BMI): BMI < 18.5 kg/m² for individuals under 70 years old, BMI < 21 kg/m² for individuals aged 70 years and older
3. Reduced Muscle Mass
4. Evident reduction in muscle mass AND

B) One of the following etiological criteria:

1. Inadequate nutritional intake:
2. Nutritional intake less than 50% of the energy requirements for more than one week
3. Reduced food intake for more than two weeks
4. Presence of Disease or Stress Metabolism
5. Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in nursing homes or long-stay geriatrics department	Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies; Patients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 mattress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: SYSTAM
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Sylvie MEAUME, Hôpital ROSCHILD

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Pressure ulcer; Low air pressure motorised mattress
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2023-A01556-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No