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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
SASS applied on chronic skin wounds as skin graft
The Hospital for Sick Children
Toronto, Ontario, Canada
Percent reduction in wound surface area
Clinical assessment
Time frame: 2 weeks
Graft failure
Clinical assessment
Time frame: 2 weeks
Number of subsequent re-transplantation
Number
Time frame: 3 years
Time (in weeks) to 50% reduction in the surface area of the wounds;
Clinical assessment
Time frame: 3 years
Time (in weeks) to complete healing
Clinical assessment
Time frame: 3 years
Changes in pain scores
10 point visual analog scale where 0 is none and 10 the worst pain
Time frame: 3 years
Changes in itch scores where 0 is none and 10 the worst itch
10 point scale
Time frame: 3 years
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