Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

Inclusion criteria

• Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:

• Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
• Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours
• Informed consent by patients/parents or other legal representatives

Exclusion criteria

• Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
• 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. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
• Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
• Previous enrolment of the patient into the current study
• Participation of the patient in another study within 30 days preceding and during the present study
• Patients or parents/other legal representatives expected not to comply with the study protocol
• Suspicion of child abuse
• Pregnant or breast feeding females
• Contamination derived from biopsy which could interfere with patients health
• Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
• Skin substitute has not been released due to production specific deviations
• Patients allergic to amphotericin B and gentamicin