A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults and adolescents in comparison to autologous split-thickness skin grafts (STSG) (BA)
This research study is looking at a new way to treat deep skin burns in adults and teenagers. It involves using a special 'bio-engineered' skin graft, created from a patient's own cells, to see how well it heals burns compared to the usual skin grafting method. Researchers want to find out if this new type of graft is safe and effective in helping the skin recover. They will compare how much of the burned area is covered by the new skin and observe the quality of the new skin and any side effects over time. The goal is to improve treatment options for people with severe burns.
At a glance
What is this study about?
This study is investigating a new and innovative way to help people with deep burns heal better. When someone has a severe burn that goes deep into the skin, the body often needs help to repair it. One common treatment is a skin graft, where healthy skin is taken from another part of the body and placed on the burned area. This study is exploring a different approach using something called a 'bio-engineered dermo-epidermal skin substitute,' which is essentially a new type of skin created in a lab from a small sample of the patient's own skin cells.
Researchers want to see if this new skin substitute, called EHSG-KF, works as well as, or even better than, the standard skin grafting procedure. They will carefully compare how both methods help the burn heal, how the new skin looks and feels, and if there are any problems. The study focuses on adults and teenagers who have 'partial deep dermal' or 'full thickness' burns, which are types of burns that affect deeper layers of the skin.
The main goal is to figure out if the EHSG-KF skin substitute effectively covers and heals the burned area. They will also keep a close eye on safety, checking for any infections or other side effects. Over a year, they will regularly assess the quality of the new skin, including its elasticity and overall appearance, to understand the long-term benefits.
Key takeaways
- This study evaluates a new type of skin graft made from your own cells.
- It aims to improve healing and scar quality for deep burns.
- Compares the new graft to standard skin grafting methods.
- Involves regular check-ups over about a year to monitor progress and safety.
- Open to adults and teenagers (18 years and older) with specific deep burns.
Who may be eligible?
This study is looking for volunteers who are adults or teenagers with certain types of severe burns. To take part, you must be at least 18 years old – there's no upper age limit.
The types of burns considered for this study are those that are deep, called 'partial deep dermal' or 'full thickness' burns. These are burns that go deeper than just the surface of the skin and often require medical intervention to heal.
If you have these types of burns, the study team will carry out further checks to make sure the trial is suitable for you. This is to ensure your safety and that the study results are clear and helpful for future burn treatments.
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 deep burns that doctors describe as 'partial deep dermal' or 'full thickness'?
- Are you able to attend regular follow-up appointments for about a year?
- Are you willing for parts of your burn to be treated with a new method and other parts with a standard method?
What does participation involve?
If you decide to take part in this study, you would have some of your burn area treated with the experimental skin substitute (EHSG-KF) and another part with the standard skin graft. This allows doctors to compare the two methods directly on you. There will be several hospital visits for assessments over the course of about a year.
During these visits, doctors and nurses will check how well your burns are healing, look for any signs of infection, and assess the quality of your new skin. They might take measurements of the healed skin's elasticity and use a special tool to assess the scar quality. They will also ask you about any side effects you might experience.
The first month after your skin grafting, you'll have frequent check-ups (around four visits). After that, the visits will become less frequent, with further checks at 3 months and then a final assessment around 1 year after the grafting. You will not need to take any special medication for the study, but your usual burn care will continue.
Potential risks and benefits
Locations (1)
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Common questions
What is a 'bio-engineered dermo-epidermal skin substitute'?
It's a special type of new skin grown in a lab using a small sample of your own skin cells, designed to help heal deep burns.
What kind of burns is this study looking at?
This study is for deep burns, specifically 'partial deep dermal' and 'full thickness' burns, in adults and teenagers.
How long does the study last if I take part?
You would be followed for about a year after your skin graft procedure, with several visits during that time.
Will I receive both the new treatment and standard grafting?
Yes, parts of your burn will be treated with the new skin substitute and other parts with standard skin grafts for comparison.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point, and your decision will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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