Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients

Exclusion Criteria

• •1. Medically unable to consent to study requirements
• •2. Treatment site(s) (skin graft site) located on the face and genitalia
• •3. Treatment site(s) (skin graft site) take more than 14 days after the skin graft surgery to reach complete re-epithelization, based on the investigator's assessment
• •4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
• •5. Pregnant, or attempting to become pregnant
• •6. Subjects who had taken part in an interventional clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not
• •7. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
• •8. Subjects who smoke more than 20 cigarettes a day
• •9. Subjects who have a history of heavy drinking in the past month, defined as more than 14 drinks per week for men or more than 7 drinks per week for women
• •10. Subjects who have a history of substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention)
• •11. Subjects with severe inhalation injury requiring FiO2 \>50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of study treatment
• •12. Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment sites
• •13. Subjects with a history of abnormal keloid scarring
• •14. Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, uncontrolled HIV infection, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing
• •15. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
• •16. A history of radiotherapy to the study scar area
• •17. Subjects who have known sensitivities to any components of the IPs
• •18. Any other diagnosis, condition, physical or geographical limitation with the participant