Comparison · NCT02278718-sae
NexoBrid Gel vs Standard of Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. NexoBrid Gel vs Standard of Care: serious adverse events. Trial comparisons, record NCT02278718-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02278718-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.029 | 0.00799 | 0.0997 | wilson | |
| Risk in group 2 | 0.0857 | 0.0399 | 0.175 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0567 | -0.148 | 0.0275 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.338 | 0.0707 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 0.318 | 0.062 | 1.64 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on NexoBrid Gel than on Standard of Care | 17.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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: NexoBrid is an enzymatic debriding agent for Eschar Removal. | 2 | 69 | EG000 |
| Group 2 | Standard of Care | Non surgical and Surgical Debridement~Standard of Care: Surgical or Non-Surgical methods for Eschar Removal | 6 | 70 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
- NCT number
- NCT02278718
- Phases
- PHASE3
- Conditions
- Thermal Burns
- Interventions
- NexoBrid, Standard of Care
- Lead sponsor
- MediWound Ltd
- Results first posted
- 2024-09-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02278718?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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