Skin Substitute for Burns
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: CHU de Quebec-Universite Laval
Disqualifiers: Connective tissue diseases, Immunodeficiency, Diabetes, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345Is 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.
13467How 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.
12358Eligibility 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
+4 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Foothill Medcial CentreCalgary, Canada
Mackenzie Health Science's CentreEdmonton, Canada
BC Children's Hospital Plastic Surgery ClinicVancouver, Canada
Winnipeg Health Science CenterWinnipeg, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
CHU de Quebec-Universite LavalLead Sponsor
References
The Self-Assembled Skin Substitute History: Successes, Challenges, and Current Treatment Indications. [2023]The self-assembled skin substitute (SASS) is an autologous bilayered skin substitute designed by our academic laboratory, the Laboratoire d'Organogenèse Expérimentale (LOEX) to offer definitive treatment for patients lacking donor sites (unwounded skin) to cover their burn wounds. This product shows skin-like attributes, such as an autologous dermal and epidermal layer, and is easily manipulable by the surgeon. Its development stems from the need for skin replacement in high total body surface area burned survivors presenting few donor sites for standard split-thickness skin grafting. This review aims to present the history, successes, challenges, and current therapeutic indications of this skin substitute. We review the product's development history, before discussing current production techniques, as well as clinical use. The progression observed since the initial SASS production technique described in 1999, up to the most recent technique expresses significant advances made in the technical aspect of our product, such as the reduction of the production time. We then explore the efficacy and benefits of SASS over existing skin substitutes and discuss the outcomes of a recent study focusing on the successful treatment of 14 patients. Moreover, an ongoing cross-Canada study is further assessing the product's safety and efficacy. The limitations and technical challenges of SASS are also discussed.
Improved Methods to Produce Tissue-Engineered Skin Substitutes Suitable for the Permanent Closure of Full-Thickness Skin Injuries. [2020]There is a clinical need for skin substitutes to replace full-thickness skin loss. Our group has developed a bilayered skin substitute produced from the patient's own fibroblasts and keratinocytes referred to as Self-Assembled Skin Substitute (SASS). After cell isolation and expansion, the current time required to produce SASS is 45 days. We aimed to optimize the manufacturing process to standardize the production of SASS and to reduce production time. The new approach consisted in seeding keratinocytes on a fibroblast-derived tissue sheet before its detachment from the culture plate. Four days following keratinocyte seeding, the resulting tissue was stacked on two fibroblast-derived tissue sheets and cultured at the air-liquid interface for 10 days. The resulting total production time was 31 days. An alternative method adapted to more contractile fibroblasts was also developed. It consisted in adding a peripheral frame before seeding fibroblasts in the culture plate. SASSs produced by both new methods shared similar histology, contractile behavior in vitro and in vivo evolution after grafting onto mice when compared with SASSs produced by the 45-day standard method. In conclusion, the new approach for the production of high-quality human skin substitutes should allow an earlier autologous grafting for the treatment of severely burned patients.
Autologous bilayered self-assembled skin substitutes (SASSs) as permanent grafts: a case series of 14 severely burned patients indicating clinical effectiveness. [2022]Split-thickness skin autografts (AGs) are the standard surgical treatment for severe burn injuries. However, the treatment of patients with substantial skin loss is limited by the availability of donor sites for skin harvesting. As an alternative to skin autografts, our research group developed autologous self-assembled skin substitutes (SASSs), allowing the replacement of both dermis and epidermis in a single surgical procedure. 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 Health Canada's Special Access Program. SASSs were grafted on debrided full-thickness wounds according to similar protocols used for AGs. The graft-take and the persistence of the SASS epithelium over time were evaluated. 14 patients received surgical care with SASSs. The mean percentage of the SASS graft-take was 98 % (standard deviation = 5) at 5 to 7 d after surgery. SASS integrity persisted over time (average follow-up time: 3.2 years), without noticeable deficiency in epidermal regeneration. Assessment of scar quality (skin elasticity, erythema, thickness) was performed on a subset of patients. Non-homogeneous pigmentation was noticed in several patients. These results indicated that the SASS allowed the successful coverage of full-thickness burns given its high graft-take, aesthetic outcome equivalent to autografting and the promotion of long-term tissue regeneration. When skin donor sites are in short supply, SASSs could be a valuable alternative to treat patients with full-thickness burns covering more than 50 % of their total body surface area.
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]Despite present optimal standard treatment of lower-extremity ulceration, a high incidence of recurrence and treatment failure is observed. The objective of this project was to evaluate the effect of a self-assembled skin substitute (SASS) made by tissue engineering as a temporary cutaneous dressing in the treatment of hard-to-heal chronic ulcers.
Biofabrication and preclinical evaluation of a large-sized human self-assembled skin substitute. [2022]Severe skin burns are widely treated using split-thickness skin autografts. However, the accessibility of the donor site may be limited depending on the size of the injured surface. As an alternative to skin autografts, our laboratory is clinically investigating a model of human self-assembled skin substitute (SASS) with a standard size of 35 cm2. For the management of extensive skin wounds, multiple grafts are required to cover the entire wound bed. Even if SASSs could provide an adequate and efficient treatment, in some cases, the long-term follow-up of the skin graft site reveals the appearance of marks at the junction between SASSs. This study aims to produce a large-sized self-assembled skin substitute (L-SASS; 289 cm2) and evaluate its preclinical potential for skin wound coverage. The L-SASSs and SASSs shared similar contraction behavior on an agar surface, thickness, and epidermal differentiation in vitro. After grafting, similar histological results were obtained for skin substitutes produced with both methods. Hence, the self-assembly approach of tissue engineering is a scaffold-free method that allows the production of living skin substitutes in a large format.
Surviving an Extensive Burn Injury Using Advanced Skin Replacement Technologies. [2022]There have been significant improvements in the technology available for treating extensive burns in the past decade. This case presents two unique, skin replacement technologies that were used to treat an 86% surface area flame burn in a pediatric patient. A temporary dermal replacement, known as "Novosorb™ Biodegradable Temporizing Matrix" was first used to stabilize the burn injury and remained in place for approximately 3 months. Given the large burn size and lack of available donor skin for grafting, a permanent skin replacement product known as "Self-Assembled Skin Substitute (SASS)" was then utilized to cover the burns. SASS is a novel technology that was developed to replace skin as an autologous skin graft and is currently available in Canada through a clinical trial for major burns. Ultimately, the concurrent use of these two technologies allowed for the unprecedented survival of a child following an extensive and life-threatening burn injury.
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]Label="Background" NlmCategory="UNASSIGNED">The aim of this in vitro study was to compare side-by-side two models of human bilayered tissue-engineered skin substitutes (hbTESSs) designed for the treatment of severely burned patients. These are the scaffold-free self-assembled skin substitute (SASS) and the human plasma-based skin substitute (HPSS).
[Currently available skin substitutes]. [2018]The current trend of burn wound care has shifted to more holistic approach of improvement in the long-term form and function of the healed burn wounds and quality of life. Autologous split or full-thickness skin graft are the best definitive burn wound coverage, but it is constrained by the limited available sources, especially in major burns. Donor site morbidities in term of additional wounds and scarring are also of concern of the autograft application. This has demanded the emergence of various skin substitutes in the management of acute burn injury as well as post burn reconstructions. This paper reviews currently available skin substitutes, produced in not for-profit skin banks as well as commercially available. They are divided according to type of material included, as biological, biosynthetic and synthetic and named respectively.