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

NCT06438042 | Recruiting

• 1 other identifier: 2023-A01556-39
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer

Keywords

Prevention; Pressure ulcer; Low air pressure motorised mattress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• Assessment of the degree of maceration

  On a scale from 1 (constantly moist) to 4 rarely moist

• Assessment of mattress safety

  At day 35

Study Arms (1)

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

Interventions

Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies DEVICE

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

Patients in nursing homes or long-stay geriatrics department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in nursing homes or long-stay geriatrics department

You may qualify if:

• 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 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

You may not qualify if:

• Patient at end of life (estimated life expectancy less than 6 months)
• Patient discharge from the establishment expected within two months
• A) One or more of the following phenotypic criteria:
• Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months
• 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
• Reduced Muscle Mass
• Evident reduction in muscle mass AND
• B) One of the following etiological criteria:
• Inadequate nutritional intake:
• Nutritional intake less than 50% of the energy requirements for more than one week
• Reduced food intake for more than two weeks
• Presence of Disease or Stress Metabolism
• Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements .

Sponsors & Collaborators

• SYSTAM: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiples locations

Multiple Locations, France

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sylvie MEAUME

  Hôpital ROSCHILD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud URBINELLI

CONTACT

0756882093; contact@clin-experts.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: June 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

FR (1)