A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Status:
Unknown status
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
This study will be a three-arms study intending to demonstrate superiority of NexoBrid
treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn
subjects.
The study objectives are:
1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing
complete eschar removal as compared with Gel vehicle,
2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing
earlier complete eschar removal, reduction in patients' surgical burden and its related
blood loss as compared to SOC,
3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment
with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and
long term outcomes of cosmesis and function.