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Enzymatic Debridement Agent

NexoBrid for Thermal Burns

Phase 3
Waitlist Available
Research Sponsored by MediWound Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed from randomization date and daily for the duration of hospital stay, an expected average of 3 weeks
Awards & highlights

Study Summary

This trial will compare the effects of a new burn treatment against the current standard of care.

Eligible Conditions
  • Thermal Burns

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed from randomization date and daily for the duration of hospital stay, an expected average of 3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed from randomization date and daily for the duration of hospital stay, an expected average of 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Earlier eschar removal (in days)

Side effects data

From 2020 Phase 3 trial • 175 Patients • NCT02148705
9%
Constipation
7%
Pyrexia
7%
Pruritis
7%
Joint Range of Motion Decreased
6%
Wound Infection Bacterial
4%
Insomnia
4%
Sinusitus
4%
Graft Loss
3%
Pain
3%
Nausea
3%
Wound Complications
1%
Cholecystectomy
1%
Acute Respiratory Distress Syndrome
1%
Deep Vein Thrombosis
1%
Pulmonary Embolism
1%
Squamous Cell Carcinoma of the Oral Cavity
1%
Anxiety
1%
Glioblastoma
1%
Acute Coronary syndrome
1%
Chest Pain
1%
Bifascicular Block
1%
Clostridium Difficile Infection
1%
Septic Shock
1%
Diabetic Metabolic Decompensation
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care (SOC)
NexoBrid Gel
Gel Vehicle

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NexoBrid GelExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
Non surgical and Surgical Debridement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NexoBrid
2015
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

MediWound LtdLead Sponsor
11 Previous Clinical Trials
884 Total Patients Enrolled
2 Trials studying Thermal Burns
175 Patients Enrolled for Thermal Burns
Yaron Shoham, Dr.Study DirectorMediWound Ltd
Lior Rosenberg, Prof.Study ChairMediWound Ltd
2 Previous Clinical Trials
44 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are included in this research project?

"As of right now, this study is not looking for any more patients. The trial was first posted on May 1st, 2015 and the most recent update was on July 24th, 2022. There are other options available though; 85 trials for thermal burns and 2 for NexoBrid are currently open to enrolling new participants."

Answered by AI

How can I become a part of this research project?

"Children aged 0 to 17 that have received thermal burns are eligible for this study. The research team is looking to enroll around 145 total patients."

Answered by AI

Does the use of NexoBrid have a history?

"The first clinical trial studying NexoBrid was completed in 2015 at University of Utah Health. As of now, a total of 228 have been conducted with 2 live trials. The majority of these studies take place in Seattle, Washington."

Answered by AI

Does this research project allow for elderly participants?

"Children who are 17 years old or younger are eligible to participate in this study."

Answered by AI

Does this study have a presence in several hospitals across Canada?

"Harborview Medical Center in Seattle, Washington, Drexel University in Philadelphia, Pennsylvania, and University of Miami in Miami, Florida are 3 of the 15 sites currently running this trial."

Answered by AI

Are researchers currently looking for participants in this trial?

"Unfortunately, this study is no longer looking for participants, as is reflected in the clinicaltrials.gov posting. The listing was first made on May 1st, 2015 and edited most recently on July 24th, 2022. There are 87 other trials with open recruitment at this time."

Answered by AI

Has the FDA sanctioned NexoBrid for public use?

"NexoBrid's safety is based on pre-existing evidence and Phase 3 trial data, which our team has rated as a 3."

Answered by AI

Does this clinical trial represent a new development in medical research?

"There are 2 active clinical trials being conducted for NexoBrid. The first study began in 2015 and is sponsored by MediWound Ltd. That particular trial reached Phase 3 drug approval stage with the completion of 145 patient cases. As of now, a total of 228 Phase 3 trials have been completed since 2015."

Answered by AI

What is the primary indication for NexoBrid?

"NexoBrid is an effective medical treatment for deep partial-thickness thermal burns, eschar removal, and deep full-thickness thermal burns."

Answered by AI
~15 spots leftby Apr 2025