A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
Summary
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
Timeline
- Start
- 2015-05
- Primary completion
- 2021-04
- Completion
- 2022-12
Outcome
Met primary endpoint
registry MEDIAN NexoBrid Gel: 0.99 (0.88 to 1.4) Days NCT02278718 ↗
registry analysis (superiority test); NexoBrid Gel vs Standard of Care; p = 0.0008; Generalized Wilcoxon-Gehan Test NCT02278718 ↗
paper The median time to complete eschar removal was significantly lower in the BBD arm (1 vs. 6 days, P < 0.001). PMID 40117996 ↗
release “Positive top line results from phase III pediatric study (CIDS) for eschar removal of severe thermal burns; met all primary endpoints” mediwound.com ↗
release “The study met its three primary endpoints with a high degree of statistical significance.” mediwound.com ↗
release “Findings in Burns Journal confirm NexoBrid’s superiority over standard of care in pediatric patients with deep thermal burns” mediwound.com ↗
release “All co-primary endpoints were successfully met” mediwound.com ↗
Publications
- Background Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.
- Shoham Y, Rosenberg L, Narayan RP, Staubach R, Bene R, Kakola M, Monstrey SJ, Wilson Y, Jha M, Lewis GM, Larson S, Singer AJ. Open label randomized controlled trial of the efficacy and safety of NexoBrid compared to standard of care in children with burns. Burns. 2025 May;51(4):107417. doi: 10.1016/j.burns.2025.107417. Epub 2025 Feb 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anacaulase-bcdb | Protein / enzyme biologic | 2 g | Topical |
| Subject | anacaulase-bcdb | Protein / enzyme biologic | 5 g | Topical |
Indications
No indication recorded.