RecruitingNAINTERVENTIONAL

RCT Exudate Management Cutimed Sorbion Product Range

This study is looking at different types of special dressings designed to absorb fluid from wounds. These dressings are called 'superabsorbent' because they can hold a lot of fluid. The aim is to see if there's a difference in how well two commonly used dressings work for people with leg ulcers. Researchers will check how effectively these dressings soak up fluid, prevent the surrounding skin from becoming too wet (this is called maceration), and stop fluid from leaking out of the dressing itself. The study hopes to find out which dressing performs better in managing wound fluid and potentially improving healing for venous leg ulcers.

At a glance

Status

Recruiting

Phase

Sponsor

BSN Medical GmbH

Enrolment target

152

Start

10 Aug 2024

Estimated completion

31 Dec 2025

Venous Leg Ulcer

What is this study about?

Imagine you have a leg ulcer that produces a lot of fluid. This fluid, called 'exudate', can make the wound area wet, slow down healing, and sometimes cause an unpleasant smell. Specialized dressings are designed to soak up this fluid, keeping the wound drier and cleaner.

This study is comparing two different types of these special absorbent dressings. Both are already approved for use in the UK. The researchers want to see if one dressing is better than the other at managing the fluid from leg ulcers. They will be looking at important things like how much fluid the dressing can absorb, if it stops the skin around the wound from getting too soggy, and if it prevents the dressing from leaking.

The goal is to find out which dressing performs best in a real-world setting. By managing wound fluid more effectively, these dressings could help improve comfort for patients, potentially speed up healing, and reduce any unpleasant smells associated with the wound.

Key takeaways

Compares two existing absorbent dressings for leg ulcers.
Looks at how well dressings manage wound fluid and prevent leaks.
Aims to improve comfort and possibly speed up healing.
Involves regular assessments of your wound and dressing.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over with a lower leg ulcer. Your ulcer needs to have been present for at least 4 weeks but no longer than a year, and it should be within a certain size range.

You also need to be able to sign a consent form, understand what the study involves, and be willing to attend study appointments and follow all treatment instructions, including wearing compression bandages if advised by your doctor.

There are certain reasons you might not be able to join. For example, if you have certain infections or are on medications that could affect wound healing, you likely won't be able to take part. Also, if you are pregnant or breastfeeding, or have an addiction to alcohol or drugs, you would not be eligible.

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 18 years old or older?
Do you have a leg ulcer that's between 4 weeks and 1 year old?
Are you able to attend appointments and follow study instructions?
Are you NOT pregnant or breastfeeding?
Are you NOT on medications that severely affect wound healing, such as strong anti-cancer drugs or high-dose steroids?

Answer every question to see your result.

What does participation involve?

This study involves applying one of the two special absorbent dressings to your leg ulcer as part of your regular wound care. You will need to attend scheduled appointments so that the study team can check on your wound and how the dressing is working. They will assess things like how much fluid the dressing has absorbed, the condition of the skin around your wound, and if there's any leakage. You'll also need to continue with any other standard treatments for your leg ulcer, such as compression therapy, as advised by your healthcare team. The exact number of visits will be outlined when you are considering joining the study, but it will involve regular wound dressing changes and assessments.

Potential risks and benefits

Potential benefits of taking part could include receiving close monitoring of your wound and potentially experiencing better wound fluid management with one of the study dressings, which might improve comfort and promote healing. However, there's no guarantee the dressing will work better for you than your current treatment. The potential risks are usually very low with these types of dressings, but as with any wound care product, there's always a small chance of skin irritation or an allergic reaction. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

Niels Stensen Klinik, Christliches-Klinikum-Melle
Verified postcode
Melle, Germany· Recruiting
Mid Yorkshire Teaching NHS Trust Pinderfields Hospital
Verified postcode
Wakefield, United Kingdom· Recruiting
Northumbria Healthcare NHS Foundation Trust
Verified postcode
Ashington, United Kingdom· Recruiting

Common questions

What is a venous leg ulcer?

A venous leg ulcer is a long-lasting sore on the lower leg, often caused by problems with blood circulation in the veins.

What does 'exudate' mean?

Exudate is the natural fluid that comes from a wound. Too much exudate can slow healing and cause problems.

What is a 'superabsorbent dressing'?

It's a special type of dressing designed to soak up and hold a large amount of fluid from a wound.

Will I know which dressing I'm getting?

The study aims to compare two dressings, so you will be assigned one of them. The study team can give you more details about this.

Can I stop participating if I want to?

Yes, you can leave the study at any time without giving a reason, and your medical care will not be affected.

How to find out more

Hardy Schweigel, PhD

hardy.schweigel@essity.com +491522 Official trial record

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