RecruitingNAINTERVENTIONAL

Oasis Donor Site Wounds Post-Market Study

This study is checking how safe and effective a special dressing called Oasis ECM is for people who have had a skin graft. When you have a skin graft, doctors take a thin layer of skin from one part of your body (the 'donor site') to cover another area. The donor site then needs to heal. Oasis ECM is a type of wound dressing that’s already available for different kinds of wounds. This study wants to find out if it helps these donor site wounds heal better than the usual care they receive. About 40 adults in the UK will take part, with some receiving the Oasis ECM and others getting standard wound care.

At a glance

Status

Recruiting

Phase

Sponsor

Cook Biotech Incorporated

Enrolment target

Start

01 Nov 2020

Estimated completion

01 Dec 2025

Surgical Wound Wound Wounds and Injuries Wound Heal

What is this study about?

Imagine you need a skin graft, which is an operation where doctors take a small piece of healthy skin from one part of your body to fix another area that's damaged, like after a burn or injury. The place where the skin is taken from is called the 'donor site'. Just like any wound, this donor site needs to heal.

This study is looking at a specific dressing called Oasis ECM. Oasis ECM is already used to help different types of wounds heal. This study wants to see if it can specifically help donor site wounds heal well and safely. Researchers will compare it to the 'standard care', which is the usual way these wounds are looked after. The main goal is to find out if Oasis ECM helps these wounds heal better.

About 40 people in the UK, aged 16 or older, will be involved in this study. They will be split into two groups – one group will have their donor site treated with Oasis ECM, and the other group will receive the standard wound care. By comparing the two groups, the researchers hope to learn if Oasis ECM is a good option for people with donor site wounds.

Key takeaways

This study looks at a special wound dressing for skin graft donor sites.
It compares Oasis ECM with the usual wound care.
About 40 adults in the UK will take part.
The aim is to see if Oasis ECM helps wounds heal safely and effectively.
Participation involves regular check-ups to monitor wound healing.

Who may be eligible?

To be able to join this study, you would need to have had a skin graft where skin was taken from another part of your body. The area where the skin was taken from (the 'donor site') must be a certain size, not too big. You also need to have at least 24 hours to think about joining and give your permission.

There are some reasons why you might not be able to join. For example, if you are under 16, or if a doctor feels you have other health problems that could make your wound healing difficult. These might include certain long-term illnesses like severe kidney or liver problems, uncontrolled diabetes, or certain blood conditions. Also, if you have an infection in the wound area, or if you're taking certain medications that affect wound healing, you might not be suitable.

Finally, if you have a known allergy to pig products (as Oasis ECM is made from pig tissue) or if your culture or religion means you can't use pig products, you wouldn't be able to participate. You also need to be able to attend all the follow-up appointments and generally be well enough 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.

Have you recently had skin taken for a graft (a 'donor site' wound)?
Is your donor site wound no bigger than 14cm by 20cm?
Are you 16 years old or older?
Do you have any health conditions that might stop wounds from healing well (like uncontrolled diabetes, severe kidney problems, or infection)?
Are you able to attend all possible study appointments?
Do you have any cultural or religious objections to products made from pig tissue?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will either receive the Oasis ECM dressing on your wound or the standard usual wound care. The study will involve regular check-ups to see how your wound is healing. This will include doctors or nurses looking at your wound and possibly taking measurements or pictures. You'll need to attend all scheduled appointments so the research team can carefully monitor your progress. The total duration of your involvement will depend on how quickly your wound heals and the study's follow-up schedule.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving a new type of wound care that might help your wound heal differently. However, there's no guarantee that the new dressing will be better than standard care. As with any medical treatment, there could be some risks, such as an allergic reaction to the dressing or a wound infection, although these would be carefully monitored by the medical team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a 'donor site wound'?

It's the area on your body where doctors take a small piece of skin for a skin graft. This area then becomes a wound that needs to heal.

What is Oasis ECM?

Oasis ECM is a special type of dressing designed to help different kinds of wounds heal. It's made from pig tissue.

Will I know if I'm getting Oasis ECM or standard care?

The study design might mean you won't know which type of dressing you are getting until the study is over. The team will explain this to you.

How many times will I need to visit the hospital?

You will need to attend several follow-up appointments so the medical team can check your wound's healing progress. The exact number will be explained by the study team.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason. Your decision will not affect your standard medical care.

How to find out more

Carina Gregory, MS

cgregory@rtix.com 765-497-3355 Official trial record

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