Safety and Efficacy of I-020502 in Meshed Skin Autografting

Inclusion criteria

• Written informed consent by the patient or his/her legal representative.
• Male or female, aged ≥ 18 years.
• Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
• Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
• Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 cm2.
• Patients who are willing to comply with treatment applications and instructions by the protocol.

Exclusion criteria

• Females who are pregnant or breast-feeding.
• Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
• Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
• Electrical and/or chemical burns.
• Patients that are judged to have significant pulmonary compromise.
• Transcutaneous tissue oxygenation < 90%.
• Clinically significant infections at wound sites.
• Clinically significant systemic infections.
• Suspicion or presence of active systemic or local cancer or tumor of any kind.
• Patients with known immunodeficiency disorders, either congenital or acquired.
• Patients with vascular or skin disorders that directly affect the designated wound site.
• Patients with Diabetes mellitus.
• Patients with chronic malnourishment.
• Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
• Any other acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to skin mesh grafting and study participation.
• Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.