Pressure InjuryNCT05472974
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress
An observational study of Pressure Injury, run by Wellell France at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Use of a powered alternating pressure air mattress
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 5 sitesFrance
- Study dates
- 17 Sep 2018to 22 Jul 2019
- 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 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Ehpad Du Parc Chateau D'Abondant
Abondant
Ehpad Esbv
Baugé-en-Anjou
Ehpad Residence Le Parc
Fontenay-aux-Roses
Ehpad Duc de Lorge
Saint-Jean-d'Illac
Ehpad Villa Du Tertre
Saint-Parres-aux-Tertres
About this study
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
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.
Read more
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.
- Conditions
- Pressure Injury
- Being tested
- Use of a powered alternating pressure air mattress
- Keywords
- Pressure injury, Life support system, Beds, Prevention
- 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 alternating pressure air mattressDevice
Patients with a medium to high risk of pressure injury, without pressure injury, up during the day, will ly a on a specific P-APAM (DOMUS 4 /AUTO)
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: 35 days after installation on the mattress (at day 35)
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 posted25 Jul 2022
- Study start17 Sep 2018
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellell France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Sylvie MEAUME, Pr, Principal investigator, Hôpital ROTSCHILD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472974
- Sponsor's protocol ID
- 2018-A01274-51
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05472974
- Acronym / sponsor ID
- 2018-A01274-51
- Conditions
- Pressure Injury
- Keywords
- Pressure injury, Life support system, Beds, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Wellell FranceIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 25 Jul 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 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
Key exclusion criteria (10 listed)
- 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 over 70:
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 alternating pressure air mattressPatients with a medium to high risk of pressure injury, without pressure injury, up during the day, will ly a on a specific P-APAM (DOMUS 4 /AUTO) | Device | – |
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: 35 days after installation on the mattress (at day 35)
Assessment of mattress safety
Time frame: At day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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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, Pr principal investigator
Hôpital ROTSCHILD
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury, run by Wellell France at 5 sites 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 10 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: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 26 Jul 2022.