Skin Substitute for Burns
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Self Assembled Skin Substitute (SASS) as a permanent skin replacement for severe burn wounds. Researchers aim to determine if SASS is safe and effective for individuals with deep burns who lack enough healthy skin for traditional grafts. It suits those with burns covering over 50% of their body and insufficient donor skin. Participants will receive both SASS and another type of skin graft, called Split-thickness Autograft, to compare results. As a Phase 1, Phase 2 trial, this research focuses on understanding how SASS works in people and measuring its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this innovative treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Self Assembled Skin Substitute (SASS) has undergone testing in clinical trials for individuals with severe burns. In these studies, SASS served as a permanent skin cover for deep wounds. A report on 14 patients with serious burns showed positive results with SASS, indicating it can effectively cover and heal burn areas.
So far, the data suggests that SASS is generally well-tolerated. No major safety concerns have been reported, suggesting it might be safe for most people. It's important to remember that this treatment is still under study, so researchers continue to learn about its safety. However, the current findings are promising.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for burn treatment, which typically involves split-thickness autografts, the Self Assembled Skin Substitute (SASS) offers a unique approach by using a patient's own cells to create a skin substitute. This method is exciting because SASS aims to provide a more natural skin repair, potentially reducing the risk of rejection and improving cosmetic outcomes. Additionally, as SASS is cultivated and assembled into a skin substitute, it might offer a more tailored healing process, promoting better integration with the patient's own skin and potentially enhancing long-term recovery.
What evidence suggests that Self Assembled Skin Substitute (SASS) is effective for treating full-thickness burn wounds?
Research has shown that Self Assembled Skin Substitutes (SASS), which participants in this trial will receive, hold promise for treating severe burns. One study demonstrated that SASS provided lasting skin coverage for patients with serious burns, particularly when donor skin was scarce. A report on 14 patients with large burns showed that SASS effectively covered their wounds. This treatment involves placing SASS onto burn wounds, which has successfully aided healing. It has been used in patients with burns covering more than half of their body, suggesting effectiveness for major burn injuries.12367
Who Is on the Research Team?
Veronique J Moulin, PhD
Principal Investigator
CHU de Quebec
Are You a Good Fit for This Trial?
This trial is for individuals with deep second-degree or third-degree burns covering over 50% of their body, where traditional skin graft donor sites are limited. It's not suitable for those needing grafts only on sensitive areas like the face or hands, people with uncontrolled diabetes, coagulation disorders, connective tissue diseases, immunodeficiency before being burned, or hypersensitivity to bovine proteins.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase A
All patients receive both Self Assembled Skin Substitute (SASS) and Split-thickness autograft
Treatment Phase B
All patients receive Self Assembled Skin Substitute (SASS)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and quality of life assessments
What Are the Treatments Tested in This Trial?
Interventions
- Self Assembled Skin Substitute (SASS)
- Split-thickness Autograft
Self Assembled Skin Substitute (SASS) is already approved in Canada for the following indications:
- Severe burn wounds
- Full-thickness skin injuries
Find a Clinic Near You
Who Is Running the Clinical Trial?
CHU de Quebec-Universite Laval
Lead Sponsor