RecruitingPHASE1, PHASE2INTERVENTIONAL

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

This research study, called SASS 2, is looking into a new treatment for severe burn injuries. It focuses on people who have very large, deep burns that need new skin to heal properly. Often, in these situations, there isn't enough healthy skin left on the person's body to use for traditional skin grafts. The study is testing something called a 'Self Assembled Skin Substitute' (SASS). Researchers want to find out if SASS is a safe and effective way to permanently replace the damaged skin. This could be a significant step forward for people recovering from major burns, offering a new option when other treatments are difficult or impossible due to the extent of their injuries.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

Start

01 Dec 2015

Estimated completion

01 Jan 2029

Burns

What is this study about?

This study is called SASS 2, and it's looking for new and better ways to help people who have suffered very serious, deep burns. When someone has a severe burn, they often need new skin to heal properly. Doctors usually take healthy skin from another part of the body (this is called a skin graft) and move it to the burned area.

However, for people with very large or extensive burns, there might not be enough healthy skin available to use for these grafts. That's where this new treatment, called a 'Self Assembled Skin Substitute' (SASS), comes in. SASS is designed to act as a permanent skin replacement. The main goal of this study is to check if SASS is safe to use and if it works well to heal these difficult burns.

By taking part, you would be helping doctors understand if SASS could become a standard treatment for people with severe burns in the future, especially when their own healthy skin is limited. This research is important because it could lead to better outcomes and recovery for many burn survivors.

Key takeaways

Tests a new skin substitute (SASS) for severe burns.
Aims to help people with large burns where skin grafts are hard to do.
Checks if SASS is safe and works well as permanent new skin.
Participant consent is required.
Not for burns only on face, hands, feet, ears, or private parts.
Certain health conditions can prevent participation.

Who may be eligible?

This study is designed for people who have very serious burns, specifically deep second-degree or third-degree burns covering more than half of their body. It's particularly for those where doctors find it hard to get enough healthy skin from other parts of their body to use for standard skin grafts.

To join, you or a family member (if you're unable to give consent yourself or are under 18) must agree to take part. The research team will explain everything thoroughly before you make any decisions.

However, some conditions would mean you can't participate. These include if your burns are only on your face, hands, feet, ears, or private parts. Also, if you have certain long-term conditions like connective tissue diseases, allergies to cow proteins, bleeding problems, immune system problems, or uncontrolled diabetes before your burns, you would not be able to join. If your wound needs to be covered permanently before the SASS treatment is ready, you also 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.

Do I have deep second or third-degree burns covering more than half of my body?
Is it difficult to find enough healthy skin on my body for regular skin grafts?
Do I have any pre-existing conditions like severe diabetes, bleeding problems, or immune system issues?
Am I allergic to any products made from cows?
Are my burns only on my face, hands, feet, ears, or private area?
Will I be able to give my consent, or can a family representative do so for me?

Answer every question to see your result.

What does participation involve?

The information provided doesn't give specific details about what taking part involves regarding visits, assessments, medication, follow-up, or total duration. Generally, in a clinical trial like this, you would likely have: regular check-ups with the study doctors and nurses to monitor your burns and general health; assessments of the SASS treatment area to see how it's healing; and possibly blood tests or other medical procedures. There would be a planned follow-up period to track your progress after the initial treatment. All these details would be fully explained to you by the study team, and you'd have the opportunity to ask questions before deciding to join.

Potential risks and benefits

Potential benefits could include access to a new, potentially life-changing treatment for severe burns, especially if traditional skin grafts aren't possible. However, the exact benefits are not guaranteed as this is a research study. Potential risks, which would be explained in detail by the study team, might include complications related to the SASS material itself, problems with wound healing, infection, or scarring. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Foothill Medcial Centre
Verified postcode
Calgary, Canada· Recruiting
Mackenzie Health Science's Centre
Verified postcode
Edmonton, Canada· Recruiting
BC Children's Hospital Plastic Surgery Clinic
Verified postcode
Vancouver, Canada· Recruiting
Winnipeg Health Science Center
Verified postcode
Winnipeg, Canada· Recruiting
Hospital for Sick Children (Sickkids)
Verified postcode
Toronto, Canada· Recruiting
Hôpital Sainte Justine
Verified postcode
Montreal, Canada· Recruiting
CHU de Québec - Unité des grands brûlés
Verified postcode
Québec, Canada· Recruiting

Common questions

What is SASS?

SASS stands for Self Assembled Skin Substitute. It's a new type of material designed to act as a permanent replacement for skin that has been severely burned.

Who can join this study?

This study is for people with very serious, deep burns covering a large area of their body, especially when there isn't enough healthy skin for traditional grafts.

Are there any reasons I couldn't join?

Yes, you might not be able to join if your burns are only on certain body parts like your face or hands, or if you have certain health conditions like severe diabetes or allergies to cow proteins.

Is SASS a proven treatment?

No, not yet. This is a research study (Phase 1/2) to find out if SASS is safe and if it works effectively as a new treatment. We are still learning about it.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care. Your decision will always be respected.

How to find out more

Veronique J Moulin, PhD

veronique.moulin@fmed.ulaval.ca 418-525-4444 Official trial record

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