Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
This study is looking into a new cream, called FS2, to see if it can help reduce scars in people who have had burn injuries and needed skin graft surgery. The cream will be put on the areas where the skin graft was placed and where the skin for the graft was taken from, but only after these areas have healed. For the first three months, some patients will get the FS2 cream, while others will get a control cream without the active ingredient, and neither they nor the doctors will know who is getting what. After this, everyone will use the FS2 cream for another three months. The main goal is to find out if FS2 is a safe and effective way to help prevent scar formation in burn patients.
At a glance
What is this study about?
Imagine you've had a burn that's serious enough to need a special surgery called a skin graft. This means a piece of healthy skin is taken from one part of your body (the donor site) and used to cover the burned area. While this helps your burn heal, it often leaves scars on both the new skin and where the skin was taken from.
This study is testing a special cream, called FS2, to see if it can help to make these scars less noticeable. FS2 contains an ingredient called kynurenic acid, and researchers think it might be able to improve how your skin heals after a burn. We want to find out if this cream is safe to use and if it actually helps reduce scarring.
By taking part, you would be helping us understand more about how to manage scars for future burn patients. This research could lead to better scar treatments and improve the quality of life for many people who experience burns.
Key takeaways
- This study tests a cream (FS2) to reduce burn scars after skin grafts.
- Participation involves applying cream and regular skin checks over six months.
- For the first three months, some get FS2, some get a control cream (neither you nor doctor know which).
- After three months, everyone uses FS2 for three more months.
- The study aims to find out if FS2 is safe and effective for scar improvement.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a burn patient between 12 and 65 years old. You must have had a full-thickness burn that required a skin graft, but not on your face or private areas. The grafted area should be a certain size, not too small or too large, and your overall health should be stable.
It's important that you or your legal guardian can understand the study information and are happy to take part. You should also be able to apply the cream as instructed, either by yourself or with help from a caregiver. Your body mass index (BMI) should fall within a healthy range.
You won't be able to join if you're pregnant or trying to get pregnant, or if you've been in another medical study in the last three months. Also, if your treatment sites haven't fully healed yet, or if you have certain severe mental health conditions, you wouldn't be able 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 between 12 and 65 years old?
- Have you had a full-thickness burn requiring a skin graft (not on face/genitals)?
- Has your skin graft and donor site completely healed?
- Are you able to understand the study requirements and apply the cream, or have a caregiver assist?
- Are you not pregnant or trying to become pregnant?
- Have you avoided other clinical trials in the last 3 months?
What does participation involve?
If you join this study, you'll be involved for about six months. For the first three months, you won't know if you're using the FS2 cream or a control cream (which looks the same but doesn't have the active ingredient). Your doctor won't know either. You'll apply this assigned cream to both your skin graft site and the area where the skin was taken from. After these first three months, everyone will use the FS2 cream for another three months, and everyone will know they are using FS2.
Throughout the study, you'll have regular visits where your graft and donor sites will be photographed and checked closely. Doctors will use special tools to measure and score how your scars are healing. You'll need to be able to apply the cream as instructed, or have someone help you. Your overall health will also be monitored.
Potential risks and benefits
Locations (2)
- University of Alberta, Division of Plastic SurgeryVerified postcodeEdmonton, Canada· Recruiting
- Centre for Burn Research - Hamilton Health SciencesVerified postcodeHamilton, Canada· Recruiting
Common questions
What is a 'skin graft' and a 'donor site'?
A skin graft is surgery where healthy skin is moved from one part of your body (the 'donor site') to cover a burned area on another part of your body.
Will I know if I'm getting the active cream or a dummy cream?
For the first three months, neither you nor your doctor will know if you're using the active FS2 cream or a dummy cream. After that, everyone will use the FS2 cream for another three months, and you'll know you're getting it.
How long will I be in the study?
You will be in the study for about six months in total.
What parts of my body will be treated?
The cream will be applied to the area where the skin graft was placed and the area where the skin was taken from (the donor site).
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and your regular medical care will not be affected.
How to find out more
Adam Kuttenkeuler
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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