A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults and adolescents in comparison to autologous split-thickness skin grafts (STSG) (BA)

Adults and adolescents with partial deep dermal and full thickness burns

Efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: • Ratio of covered surface area to biopsy site/donor site surface area at visit 6 (28 +/-3 days post grafting)

% Epithelialization at: o visit 8 (90 ± 5 days post grafting), Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: secondary endpoints 3-6, - Main secondary safety endpoint: Clinical and microbiologic signs of infection at visit 4 (6-10 days post grafting) and visit 5 (21 ± 2 days post grafting), - Main secondary efficacy endpoints: Scar quality at the study areas o Assessment of elasticity of the study areas using the Cutometer® at visit 10 (1 year ± 30 days post grafting) o Assessment of general scar quality at the study areas using the POSAS, a reliable and validated scar assessment tool, at: visit 10 (1 year ± 30 days post grafting), - Other secondary safety endpoint: Assessment and reporting of all observed adverse events will be carried out for the full duration of the study from visit 2 on., - Other secondary efficacy endpoint: Epithelialization at: o visit 6 (28 ± 3 days post grafting)

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