Trial · NCT02148705

A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

NCT02148705, Phase 3, Completed, MediWound Ltd; results first posted 2023-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns. Trials, record NCT02148705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02148705

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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 Subjects With Thermal Burns
NCT number: NCT02148705
Status: Completed
Phases: Phase 3
Enrollment: 175 participants, actual
Lead sponsor: MediWound Ltd
Conditions: Thermal Burns
Interventions: NexoBrid, Standard of Care (SOC), Gel Vehicle
First posted: 2014-05-28
Last updated: 2024-07-10
Results first posted: 2023-06-27

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Endpoint: Number of Participants With Complete Eschar Removal.	post application (post 2 h soaking)	Comparison of NexoBrid over Gel Vehicle for eschar removal as measured by Number of Participants with complete eschar removal at the end of the topical agent soaking period by a blinded assessor.
Secondary	Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)	Post application (post 2 h soaking) for NexoBrid arm and immediately post surgical excision for SOC arm.	Comparison of NexoBrid over SOC in number of Participants with surgical need for excisional eschar removal as measured by an analysis of incidence of surgical eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).
Secondary	Secondary Endpoint: Comparison of Time (Days) to Complete Eschar Removal	From randomization 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.	Comparison of NexoBrid over SOC with regard to the time (in days) when complete eschar removal has been achieved. Results of the Generalized Wilcoxon-Gehan Test Adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs (FAS)
Secondary	Secondary Endpoint: Patient-Level Comparison of Actual Blood Loss (Volume in mL) Related to Eschar Removal for NexoBrid vs SOC (FAS)	For NexoBrid arm, blood loss during NexoBrid application until post soaking. For SOC arm, blood loss during SOC procedures, through last dressing change for non-surgical SOC arm and through excision surgery for surgical SOC arm.	Comparison of NexoBrid over SOC with regard to the blood loss (volume in mL) occurred during the eschar removal procedures.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Endpoint: Number of Participants With Complete Eschar Removal.	post application (post 2 h soaking)	Standard of Care (SOC) is not included as it was pre-specified in the statistical analysis plan that for the primary endpoint, NexoBrid Gel will be compared only to the Gel Vehicle	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)	Post application (post 2 h soaking) for NexoBrid arm and immediately post surgical excision for SOC arm.	Gel arm is not involved in comparison as defined in the statistical analysis plan. Only NexoBrid and SOC	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Secondary Endpoint: Comparison of Time (Days) to Complete Eschar Removal	From randomization 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.	Gel arm is not involved in comparison as defined in the statistical analysis plan. Only NexoBrid and SOC	Days	MEDIAN
SECONDARY	Secondary Endpoint: Patient-Level Comparison of Actual Blood Loss (Volume in mL) Related to Eschar Removal for NexoBrid vs SOC (FAS)	For NexoBrid arm, blood loss during NexoBrid application until post soaking. For SOC arm, blood loss during SOC procedures, through last dressing change for non-surgical SOC arm and through excision surgery for surgical SOC arm.	Gel arm is not involved in comparison as defined in the statistical analysis plan. Only NexoBrid and SOC were compared	mL	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Primary Endpoint: Number of Participants With Complete Eschar Removal.	NexoBrid Gel	70		Participants
Primary Endpoint: Number of Participants With Complete Eschar Removal.	Gel Vehicle	1		Participants
Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)	NexoBrid Gel	3		Participants
Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)	Standard of Care (SOC)	54		Participants
Secondary Endpoint: Comparison of Time (Days) to Complete Eschar Removal	NexoBrid Gel	1.02	95% Confidence Interval 0.98 to 1.07	Days
Secondary Endpoint: Comparison of Time (Days) to Complete Eschar Removal	Standard of Care (SOC)	3.87	95% Confidence Interval 1.98 to 5.98	Days
Secondary Endpoint: Patient-Level Comparison of Actual Blood Loss (Volume in mL) Related to Eschar Removal for NexoBrid vs SOC (FAS)	NexoBrid Gel	14.17	Standard Deviation 512.40	mL
Secondary Endpoint: Patient-Level Comparison of Actual Blood Loss (Volume in mL) Related to Eschar Removal for NexoBrid vs SOC (FAS)	Standard of Care (SOC)	814.51	Standard Deviation 1020.32	mL

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NexoBrid Gel	75
Overall Study	STARTED	Gel Vehicle	25
Overall Study	STARTED	Standard of Care (SOC)	75
Overall Study	Treated	NexoBrid Gel	77
Overall Study	Treated	Gel Vehicle	24
Overall Study	Treated	Standard of Care (SOC)	68
Overall Study	Completed Acute Phase	NexoBrid Gel	67
Overall Study	Completed Acute Phase	Gel Vehicle	23
Overall Study	Completed Acute Phase	Standard of Care (SOC)	63
Overall Study	Completed 12M FU Period	NexoBrid Gel	57

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events198

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
other	Leukocytosis	Blood and lymphatic system disorders	NexoBrid Gel	3	77
other	Leukocytosis	Blood and lymphatic system disorders	Gel Vehicle	0	24
other	Leukocytosis	Blood and lymphatic system disorders	Standard of Care (SOC)	0	68
other	Tachycardia	Cardiac disorders	NexoBrid Gel	5	77
other	Tachycardia	Cardiac disorders	Gel Vehicle	0	24
other	Tachycardia	Cardiac disorders	Standard of Care (SOC)	0	68
other	Nausea	Gastrointestinal disorders	NexoBrid Gel	5	77
other	Nausea	Gastrointestinal disorders	Gel Vehicle	3	24
other	Nausea	Gastrointestinal disorders	Standard of Care (SOC)	2	68
other	Vomiting	Gastrointestinal disorders	NexoBrid Gel	5	77

1 to 10 of 198Source ClinicalTrials.gov

See all 198 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NexoBrid Gel	2	77
Total, all-cause mortality	Gel Vehicle	0	24
Total, all-cause mortality	Standard of Care (SOC)	0	68
Total, other adverse events	NexoBrid Gel	49	77
Total, other adverse events	Gel Vehicle	16	24
Total, other adverse events	Standard of Care (SOC)	39	68
Total, serious adverse events	NexoBrid Gel	9	77
Total, serious adverse events	Gel Vehicle	3	24
Total, serious adverse events	Standard of Care (SOC)	9	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37715999	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NexoBrid Gel vs Standard of Care (SOC): Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)	Trial comparisons
NexoBrid Gel vs Gel Vehicle: Primary Endpoint: Number of Participants With Complete Eschar Removal.	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02148705

GET https://conductscience.org/api/trials/v1/NCT02148705/events?page=2

API reference For AI assistants