Pressure UlcerNCT06438042
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
An observational study of Pressure Ulcer, run by SYSTAM at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in nursing homes or long-stay geriatrics department
Who may be able to join
- 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
Who cannot join
- 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) :
- 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
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- Reduced Muscle Mass
- Evident reduction in muscle mass AND
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies
- Keywords
- Prevention, Pressure ulcer, Low air pressure motorised mattress
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologiesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Patients in nursing homes or long-stay geriatrics department | Not described Receives: Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start11 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SYSTAM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Sylvie MEAUME, Principal investigator, Hôpital ROSCHILD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438042
- Sponsor's protocol ID
- 2023-A01556-39
- Status last verified
- Jun 2024
- First submitted
- 26 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06438042
- Acronym / sponsor ID
- 2023-A01556-39
- Conditions
- Pressure Ulcer
- Keywords
- Prevention, Pressure ulcer, Low air pressure motorised mattress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SYSTAMIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in nursing homes or long-stay geriatrics department
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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) :
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologiesPatients 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 | Device | Patients in nursing homes or long-stay geriatrics department |
Primary outcome
Percentage of patients who developed at least one stage 2 pressure injury
Time frame: 35 days after installation on the mattress (at day 35)
Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)
5 secondary outcomes
Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between
Time frame: 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)
Time frame: 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)
Time frame: 35 days after installation on the mattress (at day 35)
Assessment of the degree of maceration
Time frame: On a scale from 1 (constantly moist) to 4 rarely moist
Assessment of mattress safety
Time frame: At day 35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie MEAUME principal investigator
Hôpital ROSCHILD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by SYSTAM at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renaud URBINELLI (0756882093, contact@clin-experts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who developed at least one stage 2 pressure injury (time frame: 35 days after installation on the mattress (at day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.