Clinical Research Directory

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