Skin Substitute for Burns

Recruiting at 6 trial locations

Overseen By Lucie Germain, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Connective tissue diseases, Immunodeficiency, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

52 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 2 3 5 8}

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

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

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

Group I: Treatment (SASS) Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The self-assembled skin substitute (SASS) showed promise as a biological dressing for treating hard-to-heal chronic venous and mixed ulcers, with 14 ulcers treated in 5 patients, requiring an average of 6.7 applications for healing.

While two ulcers experienced minor infections and some recurred, the overall results indicate that SASS can be an effective adjunct to standard compression therapy for patients with ulcers unresponsive to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study on the treatment of lower-extremity chronic venous and mixed ulcers using tissue-engineered skin substitute made by the self-assembly approach. Boa, O., Cloutier, CB., Genest, H., et al.[2013]

The study successfully developed a large-sized self-assembled skin substitute (L-SASS) measuring 289 cm², which shows similar properties to the standard 35 cm² self-assembled skin substitute (SASS) in terms of contraction behavior and histological results after grafting.

Both L-SASS and SASS demonstrate effective epidermal differentiation and can serve as viable alternatives to traditional skin autografts for covering extensive skin wounds, potentially improving treatment options for severe skin burns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofabrication and preclinical evaluation of a large-sized human self-assembled skin substitute. Kawecki, F., Mayrand, D., Ayoub, A., et al.[2022]

The use of Novosorb™ Biodegradable Temporizing Matrix as a temporary dermal replacement for 3 months helped stabilize an 86% surface area flame burn in a pediatric patient, showcasing its effectiveness in managing severe burn injuries.

The introduction of Self-Assembled Skin Substitute (SASS) as a permanent skin replacement allowed for successful coverage of the burns, contributing to the child's unprecedented survival after a life-threatening injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surviving an Extensive Burn Injury Using Advanced Skin Replacement Technologies. Kelly, C., Wallace, D., Moulin, V., et al.[2022]

The study compared two types of tissue-engineered skin substitutes for burn treatment: the scaffold-free self-assembled skin substitute (SASS) and the human plasma-based skin substitute (HPSS), using cells from three human donors.

SASS showed greater resistance to tensile forces and produced more collagen, indicating potential advantages in mechanical strength and structural integrity, while HPSS was more elastic; both models exhibited similar biological characteristics, suggesting they could be effective for wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sierra-Sánchez, Á., Magne, B., Savard, E., et al.[2023]

The shift in burn wound care emphasizes improving the long-term appearance and function of healed wounds, focusing on enhancing patients' quality of life.

While autologous skin grafts are the best option for burn coverage, their use is limited by donor site complications and the availability of skin, leading to the development of various skin substitutes from not-for-profit skin banks and commercial sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Currently available skin substitutes]. Oravcová, D., Koller, J.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

The Self-Assembled Skin Substitute History: Successes, Challenges, and Current Treatment Indications. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Improved Methods to Produce Tissue-Engineered Skin Substitutes Suitable for the Permanent Closure of Full-Thickness Skin Injuries. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Autologous bilayered self-assembled skin substitutes (SASSs) as permanent grafts: a case series of 14 severely burned patients indicating clinical effectiveness. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Biofabrication and preclinical evaluation of a large-sized human self-assembled skin substitute. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Surviving an Extensive Burn Injury Using Advanced Skin Replacement Technologies. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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 Republic pubmed.ncbi.nlm.nih.gov

[Currently available skin substitutes]. [2018]