NEXOBRID Belgian registry: Prospective Assessment of Efficacy of NexoBrid in the treatment of Adult Patients with deep 2nd degree and 3rd degree dermal burns in Belgium.

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional patient registry

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (D03BA03) bromelains

  bromelains

Population studied

• Short description of the study population:
  Adult patients with deep 2nd and 3rd degree thermal burns in need of eschar removal/debridement.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  23

Study design details

• Main study objective:
  The overall study objective is a population based prospective assessment of efficacy of NexoBrid in Belgium.
• Outcomes:
  Aassessment of efficacy of debridement/eschar removal using NexoBrid to treat adult patients with deep dermal and full thickness burns, To evaluate the depth of the burns treated with NexoBrid,To document the area treated as % TBSA,To document the usage of NexoBrid, To document the evolution of wound until wound closure.
• Data analysis plan:
  The NexoBrid registry is descriptive in nature for hypothesis generation. All analyses will be descriptive in nature and performed by means of SAS 9.4Further details are given in the SAP