Randomisierte, kontrollierte, multinationale, multizentrische Phase IIb Studie zur Überprüfung der Wirksamkeit und Sicherheit von einem Hautersatzprodukt (EHSG-KF) zur Behandlung von grossflächigen und vollständigen Hautdefekten bei Kindern im Vergleich zur autologen Spalthaut-Hauttransplantaten (STSG)

Biological: EHSG-KF;Biological: STSG

Inclusion Criteria:

- Age: <12 years of age

- Deep partial thickness and/or full-thickness burns requiring surgical wound coverage

- Expected that =90 cm2 of wound (not counting the head and neck area for study patients
in The Netherlands) will remain open at 4 weeks post burn despite proceeding with
treatment in accordance with the standard of care. >20% TBSA burns can be taken as
guideline, but TBSA is not an inclusion criterion.

- Signed Informed consent

Exclusion Criteria:

- Patients tested positive for HBV, HCV, syphilis or HIV

- Patients with known underlying or concomitant medical conditions that may interfere
with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind
of congenital defect of metabolism including insulin-dependent diabetes mellitus,
Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired
immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction
(Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in
the opinion of the Investigator, has the potential to significantly delay wound
healing)

- Severe drug and alcohol abuse

- Patients with a known history of malignancy

- Pre-existing coagulation disorders as defined by INR outside its normal value, PTT
>ULN and fibrinogen Investigator's discretion

- Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin,
or bovine collagen

- Previous enrolment of the patient into the current phase II study

- Participation of the patient in another study with conflicting endpoints within 30
days preceding and during the present study

- Patients or parents/legal guardian expected not to comply with the study protocol
(including patients with severe cognitive dysfunction/impairment and severe
psychiatric disorders)

- Pregnant or breast feeding females

- Suspicion of child abuse

- Wounds in the head and neck area as study target area (only applicable for study
patients in The Netherlands)

- Enrolment of the Investigator, his/her family members, employees and other dependent
persons