A prospective, non-interventional multicenter study, performed in patients with burns, to evaluate efficacy and safety aspects of NexoBrid in clinical practice

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Application of NexoBrid in clinical practice, efficacy of training program, gathering of data on outcome of treatment and therapeutic experience with NexoBrid in clinical practice.
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, non-interventional study, performed in patients with burns, to evaluate safety and efficacy aspects of NexoBrid in clinical practice

Study drug and medical condition

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

  bromelains

Population studied

• Short description of the study population:
  Any patient who was treated with NexoBrid in order to treat burn wounds.; ; The criteria for the use of NexoBrid as per marketing authorization of NexoBrid were:; 1. Males and females; ≥ 18 years of age,; 2. Deep partial- and full-thickness thermal burns; 3. A total wound area of not more than 15% TBSA
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with burns
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To gather data about the application of NexoBrid in real clinical practice, to evaluate if application is performed in accordance to approval. The study should prove the efficacy of MediWounds’ comprehensive training program at implementation of NexoBrid. Another objective of this study is to gather data regarding outcomes of treatment and therapeutic experience with NexoBrid in clinical practice.
• Data analysis plan:
  Detailed data analysis will be provided in the final study report.