Skin Substitute for Burns

Recruiting at 7 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

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

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.

I have a connective tissue disease.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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) 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790893/

The Self-Assembled Skin Substitute History Since the 1980s, as intensive care treatment improved and skin substitutes became more readily available, survival after burn injuries significantly increased.

2. ecmjournal.org ecmjournal.org/papers/vol036/pdf/v036a10.pdf

autologous bilayered self-assembled skin substitutes The aim of the study was to assess the clinical outcome of the SASSs as a permanent coverage for full-thickness burn wounds. Patients were recruited through the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30209799/

a case series of 14 severely burned patients indicating ... The aim of the study was to assess the clinical outcome of the SASSs as a permanent coverage for full-thickness burn wounds. Patients were ...

4. isct-cytotherapy.org isct-cytotherapy.org/article/S1465-3249(18)30372-4/fulltext

First-in-human application of the self-assembled skin ... SASSs were used to treat patients suffering from severe burn wounds over more than 50% of their total body surface area. The SASSs were grafted after surgical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01655407

Safety and Efficacy Study of Autologous Engineered Skin ... This study is designed to evaluate the safety and efficacy of autologous engineered skin substitute (ESS-W) compared to conventional split-thickness AG.

6. trial.medpath.com trial.medpath.com/clinical-trial/d9a0799c0945bbcb/nct02350205-self-assembled-skin-substitute-severe-burn-wounds

SASS 2 : Self Assembled Skin Substitute for the Autologous ... This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin ...

7. withpower.com withpower.com/trial/phase-2-burns-2015-f2455

Skin Substitute for Burns 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 ...