The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Incidence of adverse events that are related to study treatment and associated with the grafting site
Time frame: Up to Month 36 after the last grafting day
Percentage of wound closure as determined
Time frame: Up to Month 3 after the last grafting day
Scar outcome assessment
Time frame: Up to Month 36 after the last grafting day
Incidence of contracture release or revision surgeries
Time frame: Up to Month 36 after the last grafting day
Incidence of increased temperature sensitivity
Time frame: Up to Month 36 after the last grafting day
Incidence of paresthesias, pain, dulling of sensation assessed
Time frame: Up to Month 36 after the last grafting day
Incidence and severity of infections at grafting sites
Time frame: Up to Month 6 after the last grafting day
Incidence of all adverse events
Time frame: Up to Month 36 after the last grafting day
Percentage area of re-grafting as determined
Time frame: Up to Month 6 after the last grafting day
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