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

Launched by BIRCH BIOMED INC · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a cream called FS2, which contains an ingredient known as kynurenic acid. The purpose of the study is to see if applying this cream can help reduce scarring in burn patients who have had skin graft surgery. The cream will be used on both the area where the new skin was placed and the area where the skin was taken from after they have healed. This trial aims to determine if FS2 is safe and effective in helping burn patients improve their skin appearance following surgery.

To participate in this study, participants must be between 18 and 60 years old, have a certain type of burn injury requiring skin grafting, and be in good health overall. They should also be able to understand the study requirements without needing a translator. If eligible, participants can expect to apply the cream as instructed by researchers, and they will be monitored for any effects of the treatment. It's important to note that certain medical conditions or histories may prevent someone from joining, so a thorough screening will be conducted. This trial is not yet recruiting participants, but it represents an opportunity to explore new ways to improve healing and reduce scarring for burn patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Medically able and willing to consent to study requirements
• • 2. Adult, male and female burn patients
• • 3. Ages 18 to 60 years of age
• • 4. Able to understand the study requirements and consent without a translator
• • 5. Have a BMI between 15 and 35 kg/m2 (inclusive)
• • 6. Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
• • 7. Have full thickness burn injury that requires partial thickness skin graft (meshed) for any location other than the face and genitalia
• • 8. Meshed skin graft size is between 50 cm2 and 800 cm2
• • 9. Maximum skin graft expansion ratio is 1:1.5
• • 10. Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers
• 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