An Observational Clinical Study to Collect Photographic Data of Wounds With Hypergranulation to Aid Development of a Hypergranulation Clinical Endpoint and Assessment Tool, And Generate Participant Reported Data to Inform Trial Design
This study aims to improve how we understand and treat a wound healing problem called hypergranulation. This is when wounds create too much new tissue, which can prevent them from healing properly. There isn't currently a standard way for healthcare professionals to measure how severe this is. We've developed a new 'Hypergranulation Tool' to help nurses grade the problem as mild, moderate, or severe. This study will test this tool in adult and child patients with ongoing leg ulcers or surgical wounds in the UK. We'll also take special 3D photos of wounds and gather patient feedback. This information will help us make the tool better and plan future research to find the best treatments.
At a glance
What is this study about?
When you have a wound, your body naturally grows new tissue to help it heal. Sometimes, though, it grows too much new tissue, and this is called hypergranulation. Think of it like a plant growing too vigorously and stopping other parts from developing properly. This extra tissue can actually get in the way and stop the wound from closing and healing completely.
Currently, it's hard for doctors and nurses to consistently say how severe hypergranulation is. This study is testing a new way to do that. We've created a special 'Hypergranulation Tool' which gives a clear guide for healthcare staff to assess and grade the severity of this extra tissue in wounds. This is important because if we can measure the problem accurately, we can better understand if treatments are working.
In this study, nurses will use this new tool on patients with certain types of wounds that have hypergranulation. We'll also be taking special photographs of these wounds to create 3D images, which can give us a very precise measurement of the extra tissue. On top of that, we'll talk to patients to hear about their experiences. All this information will help us check if our new tool works well in real-life clinics and guide us in planning future studies to find effective treatments for hypergranulation.
Key takeaways
- This study aims to develop a better way to assess hypergranulation in wounds.
- It involves testing a new 'Hypergranulation Tool' on patients.
- Participants will have their wounds photographed to create 3D images.
- The study gathers feedback from patients about their wound experience.
- It's an observational study, meaning no new treatments are given.
- Results will help design future studies focused on treating hypergranulation.
Who may be eligible?
This study is looking for both adults and children aged between 2 and 85 years old. To be included, you must have a wound with hypergranulation. This could be a leg ulcer that hasn't healed for 6 to 24 weeks, a surgical wound that hasn't healed for 2 to 24 weeks, or hypergranulation where a medical device enters your skin (like a feeding tube or breathing tube).
The excess tissue (hypergranulation) in your wound needs to be at least 2mm higher than the surrounding skin or wound base, and at least 10mm long. You also need to be generally in good health, able to attend appointments, and communicate well with the study team.
You cannot join if you are unable to give your consent, can't complete the study visits, have already been part of this study before, or are outside the aged 2 to 85 years range. We also can't include you if you have any other serious health conditions that the study doctor thinks might make it unsafe for you to take part.
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 between 2 and 85 years old?
- Do you have a leg ulcer or surgical wound that isn't healing, or hypergranulation around a medical device?
- Is the raised tissue in your wound at least 2mm high and 10mm long?
- Are you able to attend clinic appointments and talk about your wound?
- Are you generally feeling well enough to participate?
- Can you provide written consent (or a parent/guardian can for a child)?
What does participation involve?
If you decide to take part, you will have between 2 and 4 clinic visits over the course of the study. During these visits, a study nurse will use the new Hypergranulation Tool to assess your wound. They will also take special 2D photos of your wound, which can later be used to create a 3D image to measure the hypergranulation very accurately. You will also be asked to share your experience through questionnaires and possibly a short interview about your wound. There are no new treatments or medications given as part of this study; it's purely observational, meaning we are just gathering information. The total duration of your involvement will depend on how many visits you have, but it will involve attending between 2 to 4 appointments.
Potential risks and benefits
Locations (1)
- EMS HealthcareVerified postcodeEllesmere Port, United Kingdom· Recruiting
Common questions
What is hypergranulation?
It's when your body grows too much new tissue in a wound, which can stop it from healing properly.
Will I get a new treatment in this study?
No, this study is about observing and measuring wounds; you won't receive new treatments or medicines.
How many times will I need to visit the clinic?
You will need to attend between 2 and 4 clinic visits.
What kind of photos will be taken?
We will take special 2D photos of your wound that can help us create a 3D image to measure the hypergranulation.
Can children join this study?
Yes, children aged 2 years and older can take part, with consent from a parent or guardian.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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