An international, observational retrospective data collection study assessing efficacy of applied risk minimisation measures in burn patients treated with NexoBrid (NexoPASS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

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

  bromelains
• Medical condition to be studied:
  Burns second degree

  Burns third degree

Population studied

• Short description of the study population:
  All patients who received NexoBrid treatment according to the hospital routine in participating specialist burn centres which received the training program for implementation of risk minimization procedures within the frame of regular product release.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  160

Study design details

• Main study objective:
  Assessing the effectiveness of the risk minimisation activities and their effect on the incidence rate of identified risks
• Outcomes:
  Comparison of the incidence rates of the identified risks pain and pyrexia reported in a pre-defined time frames from treatment in routine clinical practice from product launch to those obtained in clinical trials after implementation of risk minimisation activities. - The compliance of the physician with the instructions from Educational Material relate to the risk minimization activities (i.e. whether antibacterial soaking before and after NexoBrid application performed, adequate pain management/administration of analgesia/sedation medication prescribed to the patient before applying NexoBrid and before removing NexoBrid).- Incidence of wound infection AEs
• Data analysis plan:
  All measured variables and derived parameters will be listed individually in listings. Tables using descriptive statistics will be provided for the primary and secondary variables as well as for other variables concerning demographics and baseline characteristics.