Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

Launched by THE METIS FOUNDATION · Jul 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Suprathel® to see if it helps burn wounds heal better and reduces the need for skin grafts compared to standard care. Researchers want to find out if Suprathel® can also lessen pain, decrease the chance of infection, lighten the workload for healthcare providers, minimize scarring, and lower treatment costs. The trial is currently looking for participants aged 18 to 75 who have received partial thickness burns from various causes, such as contact with hot liquids or flames.

If you or someone you know is interested in participating, it's important to know that certain conditions would exclude you from the trial, such as having burns from electrical injuries or infections at the time of admission. Participants will need to provide informed consent, which means they agree to take part in the study knowing what it involves. Throughout the study, participants can expect to receive either Suprathel® or standard care for their burns, and researchers will monitor their healing process closely to gather important data.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or Female ≥18 years and ≤75 years
• • Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
• • TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
• • TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
• • Subject is able and willing to sign Informed Consent or via legally authorized representative
• Exclusion Criteria:
• • Study Wound due to electrical, radioactive, or frostbite-related injury
• • Infection of wounds in the study area at admission per Investigator or treating physician discretion
• • Pregnancy/lactation
• • Subjects who are unable to follow the protocol or who are likely to be non-compliant
• • Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
• • Prisoners
• • Life expectancy less than 6 months
• • Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment