A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Condition: Thermal Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a multi-center, multi-national, randomized, controlled, assessor blinded, three-arm
      study aiming to demonstrate superiority of NexoBrid treatment over Gel Vehicle control and
      over SOC treatment in thermal burn subjects with burns. Following the enrollment of a patient
      to the study and prior to randomization Physicians will define one or more Target Wounds
      (TWs) per subject according to TWs definition. All subjects' deep (DPT and FT) burns that
      comply with the specified entrance criteria are intended to receive study treatment per the
      randomized study arm.

      The randomization procedure will be initiated only after all Target wounds of a subject have
      been defined. Patients will be assigned to the treatment arm in a 3:3:1 ratio (NexoBrid: SOC
      : Gel Vehicle).

      Patients will be treated in the same way in all study arms (NexoBrid, SOC or Gel vehicle)
      except for the eschar removal stage which will be performed as per the randomization study
      arm.

      Prior to initiation of eschar removal treatment, subjects will be medicated with appropriate
      analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions
      . Following wound cleansing and antibacterial treatments, subjects will undergo the eschar
      removal process as per treatment assignment (NexoBrid, SOC or Gel Vehicle, following
      randomization).

      Subsequent to complete eschar removal, all wounds will be assessed and treated in the same
      manner, in accordance with post-eschar removal wound care strategy. Post eschar removal,
      subjects will undergo daily vital signs and pain assessments, until hospital discharge (HD)
      and weekly assessments of wound progress, until wound closure. Following wound closure
      confirmation visit, subjects will be followed up at 1, 3, 6, 12, 18 and 24 months post wound
      closure for long term outcomes evaluation.
    

Intervention name(s): NexoBrid; Standard of Care (SOC); Gel Vehicle
Intervention type(s): Drug; Procedure; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fire/flame; scalds; contact