A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
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|ClinicalTrials.gov Identifier: NCT02278718|
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thermal Burns||Drug: NexoBrid Procedure: Standard of Care||Phase 3|
A total of 160 patients will be randomized into NexoBrid and SOC treatment (80 patients per arm).
Age distribution will be managed as follows:
- 45 patients 0-23 months old
- 45 patients 24 months-3 years old
- 30 patients 4-11 years old
- 20 patients 12-17 years old The remaining 20 patients will be enrolled to any of the above groups, per their age during enrollment.
The study will be conducted in three stages. In Stage I, at least 24 children age 4-18 years, hospitalized in burn units, with deep partial thickness burns ranging from 1%-30% TBSA, and who meet the entrance criteria, will be enrolled. Upon completion of stage I, a safety analysis will be performed on safety parameters and the results will be evaluated by a Data Safety Monitoring Board (DSMB) as defined in the agreed charter. If the DSMB does not have any safety concerns, Stage II will commence, this time enrolling at least 26 additional children aged of 1-18 years according to the study procedures. A DSMB will be convened to assess the safety data of the first 50 patients enrolled at stages 1 & 2. If the DSMB has not found any safety concerns, stage III will commence in which patients from the age of birth to 18 years will be included (stage III will include 110 remaining patients required to reach a total of 160 patients).
Following the enrollment of a subject to the study and prior to randomization, physicians will define one or more Target Wounds (TWs) per subject according to TWs definition. All subjects' DPT and FT burns that fit the specified criteria are intended to receive study treatment per randomized study arm and therefore, must be designated as TWs.
Prior to eschar removal treatment with NexoBrid or SOC 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 or SOC, following randomization). Subsequent to eschar removal, all wounds will be assessed and treated in the same manner, in accordance with post-eschar removal wound care strategy. Furthermore, subjects will undergo daily assessments (Vital signs (VS) and pain assessments) for one week and weekly assessments thereafter, until wound closure. Following wound closure, subjects will be followed up at 6 weeks, 12 weeks, and after that, at 6, 12, 18 and 24 months (for a blinded assessment of cosmesis, function and QoL evaluation).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment|
|Actual Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: NexoBrid Gel
NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm^2 of TBSA for four hours.
NexoBrid is an enzymatic debriding agent for Eschar Removal.
Active Comparator: Standard of Care
Non surgical and Surgical Debridement
Procedure: Standard of Care
Surgical or Non-Surgical methods for Eschar Removal
- Earlier eschar removal (in days) [ Time Frame: participants will be followed from randomization date and daily for the duration of hospital stay, an expected average of 3 weeks ]Demonstrate superiority over SOC for eschar removal as measured by a survival analysis of incidence of complete eschar removal as a function of time. Eschar removal will be measured at the end of the debridement starting from randomization date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278718
|Contact: Aya Ben Yaakov, Dr.||+firstname.lastname@example.org|
|Contact: Keren David-Zarbivemail@example.com|
|Study Chair:||Lior Rosenberg, Prof.||MediWound Ltd|
|Study Director:||Yaron Shoham, Dr.||MediWound Ltd|