Using a low-pressure motorized mattress to prevent pressure ulcers in high-risk patients

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

This study is testing if a special low-pressure mattress can help prevent pressure sores in adults who are at high risk while they use it for most of the day in nursing homes.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Systam (Industry-sponsored)
• Locations: 1 site (Multiple Locations)
• Trial ID: NCT06438042 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of a low air pressure motorized therapeutic mattress, the XTECH®25, in preventing pressure injuries in patients at medium to high risk. Participants will be adults over 18 years old who are at high risk for pressure ulcers and will be monitored for 35 days while using the mattress for more than 20 hours a day. The study will assess the incidence of pressure injuries, patient comfort, caregiver satisfaction, and mattress safety. It will take place in nursing homes and long-stay geriatrics departments.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are at high risk of developing pressure ulcers and do not currently have any pressure injuries.

Not a fit: Patients who are at the end of life or have a life expectancy of less than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of pressure ulcers in high-risk patients, improving their quality of life.

How similar studies have performed: Other studies have shown promising results with similar low-pressure mattress technologies in preventing pressure ulcers, indicating a potential for success.

Eligibility criteria

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 .

Where this trial is running

Multiple Locations

• Multiples locations — Multiple Locations, France (Recruiting)

Study contacts

• Principal investigator: Sylvie MEAUME — Hôpital ROSCHILD
• Study coordinator: Renaud URBINELLI

Conditions Pressure Ulcer; Prevention; Pressure ulcer; Low air pressure motorised mattress