phase iii study with an autologous dermo-epidermal skin substitute for the treatment of burns in adults and adolescents

Conditions: Burns

Summary: this multicentre phase iii clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoskin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.


Eligibility criteria:
inclusion criteria: * patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (tbsa) for which excision and standard of care (soc) (stsg) are clinically indicated * patients of either sex aged ≥12 years * signed informed consent from the patient and/or legally authorised representative exclusion criteria: * burn wound areas solely located on the head and neck (i.e., test and control areas must not be located on head/neck) * patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoskin™, for whom the application of denovoskin™ would delay the standard of care therapies * patients with serologic evidence of active hepatitis b virus (hbv) infection (i.e., positive for hepatitis b surface antigen \[hbsag\] or immunoglobulin m total hepatitis b core antibody \[anti-hbc\]), active hepatitis c infection (hepatitis c virus \[hcv\] antibody positive), positive human immunodeficiency virus (hiv) serology, or positive treponema pallidum serology assessed as per local standard of care; cured hepatitis c (defined as documented treatment and negative viral load) is not an exclusion * patients with known underlying or concomitant medical conditions that, in the opinion of the investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (hba1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases * patients with pre-existing coagulation disorders as defined by international normalised ratio (inr) outside its normal value, a prothrombin time (pt) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission * patients with a history of clinically significant hypersensitivity to amphotericin b, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine) * previous treatment with denovoskin™ * participation in any clinical interventional study within 60 days prior to the first imp administration in case of monoclonal antibodies and \<30 days for all other imps * patients unwilling or unable to comply with procedures required in this clinical study protocol * pregnant or lactating women * women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate \<1% per year) throughout the study and/or unwilling to be tested for pregnancy. a negative serum beta-human chorionic gonadotropin (β-hcg) test is required on the day of grafting * patient is the investigator, one of his/her family members, employees, and other dependent persons

Keywords: burns skin scars wound healing dermis epidermis thermal burns