The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed
University Children's Hospital Zurich: denovoDerm
Zurich, Canton of Zurich, Switzerland
University Children's Hospital Zurich: denovoSkin
Zurich, Canton of Zurich, Switzerland
Safety
Assessment/reporting of local infection rate and graft take
Time frame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Adverse events
Assessment/reporting of number of adverse events
Time frame: until 90 days post transplantation
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