Skin Substitute for Burns
Trial Summary
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.
What data supports the effectiveness of the treatment Self Assembled Skin Substitute (SASS) for burns?
Research shows that SASS has a high success rate in treating severe burns, with a 98% graft-take rate and long-term skin regeneration in patients. It is particularly useful when there are limited donor sites for traditional skin grafts, providing an effective alternative for covering large burn areas.12345
Is the Self-Assembled Skin Substitute (SASS) safe for use in humans?
The Self-Assembled Skin Substitute (SASS) has been used in clinical trials for treating severe burns, showing a high success rate in grafting and long-term skin regeneration without major safety concerns. A study involving 14 patients reported successful outcomes with SASS, and ongoing research is further assessing its safety and effectiveness.13467
How is the Self Assembled Skin Substitute (SASS) treatment different from other treatments for burns?
The Self Assembled Skin Substitute (SASS) is unique because it uses the patient's own cells to create a skin substitute that includes both the dermis and epidermis layers, making it a suitable option for patients with limited donor skin available for traditional grafts. Unlike standard treatments, SASS can be produced in a large size and offers a high graft-take rate, promoting long-term tissue regeneration and reducing the need for multiple surgeries.12358
What is the purpose of this trial?
This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.
Research Team
Veronique J Moulin, PhD
Principal Investigator
CHU de Quebec
Eligibility Criteria
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
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
Treatment Details
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