RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries

This research is investigating a new gel treatment called PluroGel for burn injuries. Many people with burns experience long-term problems from scarring and painful dressing changes. Currently, burn care often involves special dressings and sometimes surgery to remove damaged tissue. This study wants to see if PluroGel can help clean burn wounds more effectively than standard dressings, potentially reducing the amount of tissue that needs to be removed surgically. By doing this, researchers hope PluroGel could lead to less painful recovery, better healing, and a lower chance of needing extensive surgery. If successful, this could offer a new and improved way to care for certain burn patients.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Manitoba

Enrolment target

Start

01 Oct 2021

Estimated completion

01 Jun 2029

Burns

What is this study about?

Burn injuries can cause lasting problems, not just from scars but also from the discomfort of dressing changes. Currently, when someone has a burn, doctors often use special medicated dressings. Sometimes, surgery is needed to remove damaged skin, especially for deeper burns, and then new skin might be added through a graft. Deciding how deep a burn is and how best to treat it can be tricky, as it’s not always clear right away how much tissue is truly damaged.

There's a lot of interest in finding new ways to treat burns that might reduce the amount of tissue that needs to be removed and possibly even cut down on the need for surgery. We've seen some new techniques, like special devices that use water to clean wounds or gels made from pineapple that help remove dead tissue. However, these haven't always been proven to be better than current treatments in large studies, and in some cases, they might even cause issues.

This study is focusing on a new product called PluroGel. It's a special gel that works by gently cleaning the burn wound. Imagine it like tiny sponges that loosen up and trap dead skin and debris, helping to clear the wound. The goal is to see if PluroGel can do a better job at cleaning burns than the usual dressings, which could potentially mean less tissue needs to be removed surgically, leading to a smoother and less painful recovery for patients.

Key takeaways

The study compares PluroGel to standard burn dressings.
It aims to see if PluroGel helps burns heal better and reduces the need for surgery.
Participants must have specific types of partial thickness burns on their limbs.
The study is for adults aged 18 and over.
Participation involves receiving one of the treatments and having regular check-ups.

Who may be eligible?

To join this study, participants need to be adults aged 18 or older. They must have partial thickness burns on both arms or legs that are similar in depth and require them to stay in the hospital for treatment.

There are certain reasons why someone might not be able to participate. For example, if your burns cover more than 30% of your body, or if the burn is very deep (full thickness) when first assessed, you wouldn't be eligible. Also, if you've already had surgery for your burn at another hospital, or if you have existing malnutrition, you wouldn't be able to join.

Finally, if your burn was caused by electricity, chemicals, or other unusual reasons, you wouldn't be suitable for this particular study. The study aims to look at very specific types of burns and patient situations to get the clearest results possible.

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 partial thickness burns on both an arm and a leg, or both arms, or both legs?
Do your burns require you to be admitted to the hospital?
Are your burns not caused by electricity or chemicals, and do they cover less than 30% of your body?
Have you not had surgery for your current burn injury at another hospital yet?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to receive either the new PluroGel treatment or the standard dressing care for your burn injuries. The specific details of how often dressings are changed and how long you use the treatment will be determined by the study doctors, based on your burns and the study plan. You will have regular check-ups where doctors will assess your burn healing, pain levels, and overall recovery. These assessments might involve looking at your wounds, taking pictures, and asking you questions. The total duration of your participation in the study will depend on how quickly your burns heal and the follow-up schedule designed by the research team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could improve burn healing and reduce the need for surgery. However, as with any medical treatment, there are potential risks, and PluroGel may or may not be more effective than standard care. Side effects might occur, which would be carefully monitored by the medical team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your ongoing medical care.

Locations (1)

University of Manitoba
Verified postcode
Winnipeg, Canada· Recruiting

Common questions

What kind of burns is this study for?

This study is for partial thickness burns on both arms or legs that are deep enough to require a hospital stay.

What is PluroGel?

PluroGel is a special gel designed to gently clean burn wounds by loosening and trapping dead skin and debris.

Will I definitely get the new gel treatment?

You will either receive the new PluroGel treatment or the standard dressing care. This is decided by chance to make the study fair.

How long will I be in the study?

The length of your participation will depend on how your burns heal and the study's follow-up schedule.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your regular medical care.

How to find out more

Justin Gawaziuk

jgawaziuk@hsc.mb.ca 2047878682 Official trial record

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