Open label randomized controlled trial of the efficacy and safety of NexoBrid compared to standard of care in children with burns
Bibliographic record
Abstract
This study evaluated the safety and efficacy of an enzymatic bromelain-based debridement (BBD) agent (NexoBrid®) in children with deep thermal burns. We conducted a multicenter, open-label, parallel design, randomized controlled trial at 36 burn centers in Europe, US, Israel and India. Main eligibility criteria included children 0–18 years old, suffering from deep thermal burns covering 1–30 % of their total body surface area. Patients were randomized to either BBD or standard of care (SOC) eschar removal methods. Primary endpoints included time to complete eschar removal (superiority), percentage of wound area surgically excised (superiority) and blinded 12 months follow-up assessment of cosmesis and function using the Modified Vancouver Scar Scale (MVSS, non-inferiority). One hundred and forty-five children were enrolled between 2015 and 2020 (last patient completed 12-month follow-up on April 2021); 72 were randomized to BBD and 73 to SOC. All three primary endpoints of the study were met. The median time to complete eschar removal was significantly lower in the BBD arm (1 vs. 6 days, P < 0.001). The mean [SD] percentage of wound area surgically excised was also significantly lower in the BBD arm (1.5 % [12.1 %] vs. 48.1 % [46.6 %], P < 0.001). Mean [SD] 12-month MVSS scores were 3.8 [2.9] and 4.9 [3.3] in the BBD and SOC arms, respectively (non-inferiority demonstrated at P < 0.001). The incidence of adverse events was similar between the groups, and there were no significant safety issues or deaths during the trial. BBD was demonstrated to be safe and effective in children. Its use lead to a shorter time to complete eschar removal, a reduction in excisional surgery and non-inferior cosmesis and function results as compared to SOC eschar removal methods. • The aim of this study was to evaluate the safety and efficacy of NexoBrid in children suffering from deep thermal burns. • 145 deeply burned children were randomized to either NexoBrid or standard care. • Enzymatic debridement with NexoBrid was shown to be safe and effective. • NexoBrid reduced the need for excisional surgery and the time to eschar removal. • NexoBrid was recently approved for use in children by the European Medicines Agency and the US FDA.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".