52 Participants Needed

Skin Substitute for Burns

Recruiting at 6 trial locations
VJ
LG
Overseen ByLucie Germain, PhD
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: CHU de Quebec-Universite Laval
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

VJ

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

I have severe burns covering more than half of my body.
Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors
I have few areas on my body suitable for tissue donation for grafts.

Exclusion Criteria

I had uncontrolled diabetes before getting a burn injury.
I need skin grafting on my face, hands, feet, ears, or genital area only.
Hypersensitivity to bovine proteins
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase A

All patients receive both Self Assembled Skin Substitute (SASS) and Split-thickness autograft

< 1 month

Treatment Phase B

All patients receive Self Assembled Skin Substitute (SASS)

< 1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and quality of life assessments

36 months

Treatment Details

Interventions

  • Self Assembled Skin Substitute (SASS)
  • Split-thickness Autograft
Trial Overview The trial is testing a Self Assembled Skin Substitute (SASS) as a permanent solution for severe burn wounds when there's not enough healthy skin available for grafts. The goal is to see if SASS can safely and effectively replace damaged skin.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (SASS)Experimental Treatment1 Intervention
Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)

Self Assembled Skin Substitute (SASS) is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as SASS for:
  • 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

Trials
177
Recruited
110,000+

Findings from Research

The self-assembled skin substitute (SASS) is an innovative autologous skin replacement designed for patients with extensive burn injuries who lack donor sites for traditional grafting, showing promising skin-like properties.
Recent studies involving 14 patients have demonstrated the efficacy of SASS in treating burn wounds, with ongoing research assessing its safety and effectiveness across Canada, highlighting significant advancements in production techniques since its initial development in 1999.
The Self-Assembled Skin Substitute History: Successes, Challenges, and Current Treatment Indications.Dagher, J., Arcand, C., Auger, FA., et al.[2023]
The Self-Assembled Skin Substitute (SASS) can now be produced in 31 days instead of the previous 45 days, optimizing the manufacturing process for skin substitutes using the patient's own cells.
Both the new production methods resulted in skin substitutes that maintained similar quality and performance as the original method, which is crucial for effective treatment in severely burned patients.
Improved Methods to Produce Tissue-Engineered Skin Substitutes Suitable for the Permanent Closure of Full-Thickness Skin Injuries.Larouche, D., Cantin-Warren, L., Desgagné, M., et al.[2020]
In a study involving 14 patients, autologous self-assembled skin substitutes (SASSs) demonstrated a high graft-take rate of 98% within 5 to 7 days after surgery, indicating their effectiveness as a treatment for full-thickness burn wounds.
SASSs provided long-term coverage and maintained skin integrity over an average follow-up of 3.2 years, making them a promising alternative to traditional skin autografts, especially when donor skin is limited.
Autologous bilayered self-assembled skin substitutes (SASSs) as permanent grafts: a case series of 14 severely burned patients indicating clinical effectiveness.Germain, L., Larouche, D., Nedelec, B., et al.[2022]

References

The Self-Assembled Skin Substitute History: Successes, Challenges, and Current Treatment Indications. [2023]
Improved Methods to Produce Tissue-Engineered Skin Substitutes Suitable for the Permanent Closure of Full-Thickness Skin Injuries. [2020]
Autologous bilayered self-assembled skin substitutes (SASSs) as permanent grafts: a case series of 14 severely burned patients indicating clinical effectiveness. [2022]
Prospective study on the treatment of lower-extremity chronic venous and mixed ulcers using tissue-engineered skin substitute made by the self-assembly approach. [2013]
Biofabrication and preclinical evaluation of a large-sized human self-assembled skin substitute. [2022]
Surviving an Extensive Burn Injury Using Advanced Skin Replacement Technologies. [2022]
In vitro comparison of human plasma-based and self-assembled tissue-engineered skin substitutes: two different manufacturing processes for the treatment of deep and difficult to heal injuries. [2023]
8.Czech Republicpubmed.ncbi.nlm.nih.gov
[Currently available skin substitutes]. [2018]
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