Trial · NCT02278718
A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
NCT02278718, Phase 3, Completed, MediWound Ltd; results first posted 2024-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care. Trials, record NCT02278718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02278718
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
- NCT number
- NCT02278718
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 145 participants, actual
- Lead sponsor
- MediWound Ltd
- Conditions
- Thermal Burns
- Interventions
- NexoBrid, Standard of Care
- First posted
- 2014-10-30
- Last updated
- 2024-09-27
- Results first posted
- 2024-09-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Complete Eschar Removal (in Days) | From randomization date until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm. | 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, assessed until complete eschar removal is achieved (in days) |
| Secondary | Incidence of Surgical Excision Performed for Eschar Removal | Until complete eschar removal has been achieved. Complete eschar removal was achieved within 0.99 days (95% CI: 0.88 to 1.04) for the NexoBrid treatment arm and 5.99 days (95% CI: 2.71 to9.84) for the SOC treatment arm. | Number of patients who needed surgical excision for eschar removal |
| Secondary | Blood Loss Related to Eschar Removal | Hematocrit - immediately before each procedure and 4 hrs after its completion. The amount of blood transfused will be summed over all transfusions carried out during the debridement procedure and up to 24 hrs from the end time of the debridement procedure | Measured by actual blood loss \[ABL\]. Actual blood loss was the calculated blood loss summed over all procedures carried out to remove eschar, using hematocrit values measured immediately before each procedure and 4 hours after its completion and the amount of blood transfused was summed over all transfusions carried out during the debridement procedure and up to 24 hours from the end time of the debridement procedure. |
| Secondary | Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level. | Assessment will be performed by the investigator immediately after each autograft procedure was performed, before application of coverage. | Percent area of deep partial thickness wounds autografted |
| Secondary | Incidence of Autograft Performed in Deep Partial Thickness Wounds | Patient's wounds were assessed until complete healing of all wounds, during the period from complete eschar removal was achieved until complete wound closure. Median time in the population was approx. 4.5 weeks and longest follow up period was of 12 weeks | Number of autografts performed in deep partial thickness wounds |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Complete Eschar Removal (in Days) | From randomization date until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm. | All patients who were randomised into the study. | Days | MEDIAN |
| SECONDARY | Incidence of Surgical Excision Performed for Eschar Removal | Until complete eschar removal has been achieved. Complete eschar removal was achieved within 0.99 days (95% CI: 0.88 to 1.04) for the NexoBrid treatment arm and 5.99 days (95% CI: 2.71 to9.84) for the SOC treatment arm. | Incidence Rate = The proportion and number of patients who required surgical excision for eschar removal. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Blood Loss Related to Eschar Removal | Hematocrit - immediately before each procedure and 4 hrs after its completion. The amount of blood transfused will be summed over all transfusions carried out during the debridement procedure and up to 24 hrs from the end time of the debridement procedure | Full analysis set (FAS): 145 patients | mL | MEAN |
| SECONDARY | Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level. | Assessment will be performed by the investigator immediately after each autograft procedure was performed, before application of coverage. | FAS, Patients with at least one DPT target wound. | percent | MEAN |
| SECONDARY | Incidence of Autograft Performed in Deep Partial Thickness Wounds | Patient's wounds were assessed until complete healing of all wounds, during the period from complete eschar removal was achieved until complete wound closure. Median time in the population was approx. 4.5 weeks and longest follow up period was of 12 weeks | Main Analysis, Target Wound Level, Deep Partial Thickness Target Wounds Only | autographs performed | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Complete Eschar Removal (in Days) | NexoBrid Gel | 0.99 | 95% Confidence Interval 0.88 to 1.4 | Days | |
| Time to Complete Eschar Removal (in Days) | Standard of Care | 5.99 | 95% Confidence Interval 2.71 to 9.84 | Days | |
| Incidence of Surgical Excision Performed for Eschar Removal | NexoBrid Gel | 6 | Participants | ||
| Incidence of Surgical Excision Performed for Eschar Removal | Standard of Care (SOC) | 47 | Participants | ||
| Blood Loss Related to Eschar Removal | NexoBrid Gel | 32.26 | Standard Deviation 284.757 | mL | |
| Blood Loss Related to Eschar Removal | Standard of Care (SOC) | 202.55 | Standard Deviation 409.147 | mL | |
| Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level. | NexoBrid Gel | 15.9 | Standard Deviation 38.57 | percent | |
| Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level. | Standard of Care | 22.8 | Standard Deviation 43.72 | percent | |
| Incidence of Autograft Performed in Deep Partial Thickness Wounds | NexoBrid Gel | 21 | autographs performed | ||
| Incidence of Autograft Performed in Deep Partial Thickness Wounds | Standard of Care | 26 | autographs performed |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NexoBrid Gel | 72 | |
| Overall Study | STARTED | Standard of Care | 73 | |
| Overall Study | Treated | NexoBrid Gel | 69 | |
| Overall Study | Treated | Standard of Care | 70 | |
| Overall Study | Number of Patients Completed 12 Month FU | NexoBrid Gel | 66 | |
| Overall Study | Number of Patients Completed 12 Month FU | Standard of Care | 63 | |
| Overall Study | COMPLETED | NexoBrid Gel | 66 | |
| Overall Study | COMPLETED | Standard of Care | 63 | |
| Overall Study | NOT COMPLETED | NexoBrid Gel | 6 | |
| Overall Study | NOT COMPLETED | Standard of Care | 10 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | NexoBrid Gel | 0 | 69 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care | 3 | 70 | |
| other | Pain | General disorders | NexoBrid Gel | 4 | 69 | |
| other | Pain | General disorders | Standard of Care | 5 | 70 | |
| other | Constipation | Gastrointestinal disorders | NexoBrid Gel | 3 | 69 | |
| other | Constipation | Gastrointestinal disorders | Standard of Care | 1 | 70 | |
| other | Diarrhoea | Gastrointestinal disorders | NexoBrid Gel | 2 | 69 | |
| other | Diarrhoea | Gastrointestinal disorders | Standard of Care | 2 | 70 | |
| other | Nausea | Gastrointestinal disorders | NexoBrid Gel | 3 | 69 | |
| other | Nausea | Gastrointestinal disorders | Standard of Care | 3 | 70 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NexoBrid Gel | 0 | 69 |
| Total, all-cause mortality | Standard of Care | 0 | 70 |
| Total, other adverse events | NexoBrid Gel | 31 | 69 |
| Total, other adverse events | Standard of Care | 30 | 70 |
| Total, serious adverse events | NexoBrid Gel | 2 | 69 |
| Total, serious adverse events | Standard of Care | 6 | 70 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NexoBrid Gel vs Standard of Care (SOC): Incidence of Surgical Excision Performed for Eschar Removal | Trial comparisons |
| NexoBrid Gel vs Standard of Care: deaths from any cause | Trial comparisons |
| NexoBrid Gel vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02278718
GET https://conductscience.org/api/trials/v1/NCT02278718/events?page=2