Epidermolysis Bullosa Dystrophica
Conditions
Keywords
Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Tissue Engineering, Skin Substitute
Brief summary
Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.
Interventions
BIOLOGICALSASS
SASS applied on chronic skin wounds as skin graft
Sponsors
CHU de Quebec-Universite Laval
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
n-of-one
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
This clinical trial was custom designed for one patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in wound surface area | 2 weeks | Clinical assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft failure | 2 weeks | Clinical assessment |
| Number of subsequent re-transplantation | 3 years | Number |
| Time (in weeks) to 50% reduction in the surface area of the wounds; | 3 years | Clinical assessment |
| Time (in weeks) to complete healing | 3 years | Clinical assessment |
| Changes in pain scores | 3 years | 10 point visual analog scale where 0 is none and 10 the worst pain |
| Changes in itch scores where 0 is none and 10 the worst itch | 3 years | 10 point scale |
Countries
Canada
Outcome results
None listed