RecruitingOBSERVATIONAL

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 investigating a special type of mattress designed to help prevent pressure ulcers (often called bedsores) in people who are at a higher risk of getting them. These patients typically spend more than 20 hours a day lying down, for example, in nursing homes or long-term care. The researchers want to see if using this Low Air Pressure Motorised Therapeutic Mattress, called XTECH®25, can reduce how many people get pressure ulcers. They will follow participants for 35 days and check for any new ulcers. They will also look at how comfortable patients are, how happy carers are with the mattress, and if it's safe and quiet to use. This isn't a comparison study, but rather observes the effects of using the mattress alongside standard care.

At a glance

Status

Recruiting

Sponsor

SYSTAM

Enrolment target

Start

11 Jun 2024

Estimated completion

31 Dec 2025

Pressure Ulcer

What is this study about?

This study is looking at a new way to help prevent a common problem called pressure ulcers, which are also known as bedsores. These are painful skin injuries that can happen when someone spends a lot of time in one position, putting pressure on certain parts of their body, like the lower back, heels, or hips. People who are very ill, can't move much, or spend most of their day in bed or a chair are at a higher risk of getting them.

Researchers are investigating a special hospital mattress called the XTECH®25. This isn't just a regular mattress; it's designed to use moving air to constantly change the pressure points on a person's body. The idea is that by gently redistributing this pressure, it can help stop pressure ulcers from forming in the first place. The study wants to see how well this mattress works for older people in nursing homes or long-term care who are at high risk.

The study will follow people in these care settings for 35 days. During this time, they will be using the special mattress alongside the usual care measures already in place to prevent pressure ulcers. The main thing the researchers want to find out is how many people develop a new pressure ulcer of a certain severity on their lower back, spine, or heels while using the mattress. They will also be checking on things like how comfortable patients find the mattress, whether care staff are happy using it, and if it's quiet and safe.

Key takeaways

This study looks at a special mattress to help prevent bedsores.
It's for people at high risk who spend a lot of time in bed.
Participants will use the mattress for 35 days in their care home.
Researchers will check for new bedsores and patient comfort.
It's an observational study, meaning researchers watch what happens, not compare treatments.
Your usual care for preventing bedsores will continue.

Who may be eligible?

To take part in this study, you would generally need to be an adult (over 18 years old) who is considered to be at a high risk of developing pressure ulcers. This means you might have specific health conditions or a care assessment that shows you're likely to get these sores. Importantly, you mustn't already have a pressure ulcer when you join the study, and you should be spending more than 20 hours a day lying on the special XTECH®25 mattress being tested. Your weight should also be under 200 kg.

There are some reasons why you wouldn't be able to join. For example, if your doctor believes you have less than six months to live, or if you're expected to leave the care facility within two months, you wouldn't be suitable. Also, if you are significantly malnourished, based on specific medical guidelines that look at things like recent weight loss or very low body mass index (BMI) combined with poor eating habits or severe illness, you would not be able to participate. This is because malnutrition can affect wound healing and other health outcomes, potentially making it harder to properly assess the mattress alone.

Before taking part, you (or a close family member or advocate if you're unable to decide for yourself) would need to be given all the information about the study and agree to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Are you considered at high risk for getting pressure ulcers, but don't currently have any?
Do you spend more than 20 hours a day lying down?
Is your weight less than 200 kg?
Do you expect to stay in your care facility for at least the next two months?
Are you not severely malnourished according to specific medical guidelines?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would use the special XTECH®25 mattress as part of your regular care for 35 days. This will happen in your nursing home or long-term care setting. You won't be given any new medications or treatments, as the study is about the mattress itself and how it helps prevent pressure ulcers. Researchers will closely monitor your skin for any signs of new pressure ulcers, especially on your lower back, spine, or heels, throughout this 35-day period.

They will also ask about your comfort levels during this time. The care staff looking after you might be asked for their opinions on the mattress too, and the researchers will check things like how noisy the mattress is and that it's safe to use. You won't need to visit a special clinic or have extra appointments outside of your usual care; these observations will take place where you live.

Potential risks and benefits

Participating in this study might offer a potential benefit if the special mattress helps to reduce your risk of developing a pressure ulcer, which can be very painful and lead to other health problems. However, it's important to remember that this is an observational study, not one that compares the mattress to typical care, so we don't know for sure how much better it might be. There are no known significant risks directly linked to using the mattress itself, as it's designed to be safe and is used alongside your usual care. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your ongoing care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Multiples locations
Unverified
Multiple Locations, France· Recruiting

Common questions

What is a pressure ulcer?

A pressure ulcer, also called a bedsore, is a sore on your skin caused by prolonged pressure, especially on bony parts of the body. They can be painful and are common in people who spend a lot of time in bed or a chair.

What is the XTECH®25 mattress?

It's a special mattress that uses air to constantly change the pressure points on your body. This helps to prevent pressure ulcers by gently redistributing your weight.

How long will I be in the study?

If you take part, you will be in the study for a total of 35 days, using the special mattress during this time.

Do I have to do anything extra if I join?

You won't need extra appointments or new medications. You'll just use the special mattress as part of your standard care, and researchers will observe your skin and ask about your comfort.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Renaud URBINELLI

contact@clin-experts.fr 0756882093 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.