Thermal BurnsPhase 3NCT02278718
A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
A Phase 3 study testing NexoBrid in people with Thermal Burns, run by MediWound Ltd at 36 sites in 14 countries.
Trial summary
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30%… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Thermal Burns
- What is being tested?
- NexoBrid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 36 sitesin 14 countries
- Study dates
- May 2015to Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Stage 1: Males and females between 4 years to 18 years of age, Stage 2 (upon DSMB review): Males and females between 1 year to 18 years of age, Stage 3 (upon DSMB review): Males and females between 0 years to 18 years of age.
- Thermal burns caused by fire/flame, scalds or contact.
- Patient total burns area ≥ 1% DPT and / or FT,
- Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
- Signed written informed consent by a legal guardian can be obtained within 84 hours of the burn injury.
- At least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:
Show all 10Show fewer
- Wound that is ≥ 1% TBSA (DPT and/or FT) (not including face, perineal or genital),
- Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,
- Wound that is potentially intended for surgical eschar removal,
- Wound's blisters can be unroofed, as judged by the investigator.
Who cannot join
- Patients weighing less than 3kg,
- Patients who are unable to follow study procedures and follow up period,
- Patients with electrical or chemical burns,
- Patient with a continuous burn area above 15% TBSA,
- Patients with no DPT and/or FT burn area (only SPT wounds),
- Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling ≥ 80% of the trunk circumference),
Show all 27Show fewer
- The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
- Patients with diagnosed infections,
- Diagnosis of smoke inhalation injury,
- Patients with pre-enrolment wounds which are covered by eschar saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of >12h SSD treatment),
- Patients with pre-enrolment escharotomy,
- Pregnant women (positive pregnancy test) or nursing mothers,
- Poorly controlled diabetes mellitus (HbA1c>9%),
- Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, uncontrolled asthma,
- Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
- Any known conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),
- ASA greater than 2
- Chronic systemic steroid intake,
- History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
- Current (within 12 months prior to screening) suicide attempt,
- Enrollment in any investigational drug trial within 4 weeks prior to screening,
- Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse,
- Prisoners and incarcerated
- Patients who might depend on the clinical study site or investigator.
- Patient expresses objection to participate in the study.
- Patients with other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s)
- General condition of patient would contraindicate surgery
Trial locations and contacts
36 sites in 14 countries.
36 sites in 14 countries
United States13 sites
Shriners Hospital for Children
Boston, Massachusetts, 02114
Shawn Jekins Children's Hospital
Charleston, South Carolina, 29425s
University Of Florida
Gainesville, Florida, 32610
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33146
Drexel University
Philadelphia, Pennsylvania, 19134
Maricopa Special Health Care District
Phoenix, Arizona, 85008
Legacy Emanuel Hospital & Health Center dba Legacy Research Institute
Portland, Oregon, 97232
University of Utah
Salt Lake City, Utah, 84132
Harborview Medical Center
Seattle, Washington, 98104
Stony Brook University Medical Center
Stony Brook, New York, 11794
The University of South Florida Board of Trustees
Tampa, Florida, 33620
Hungary3 sites
MRE Bethesda Gyermekkórháza
Budapest, H-1146
B.A.Z Megyei Kórház és Egyetemi Oktatókórház
Miskolc, H-3526
Klinikai Kozpont Gyermekgyogyaszati Klinika
Pécs, H-7624
India3 sites
Krishna Rajendra Hospital
Mysuru, 570001
Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg
New Delhi, National Capital Territory of Delhi, 110001
Vardhman Mahavir Medical College (VLCC) and Safdarjung Hospital
New Delhi, 110029
Germany2 sites
Unfallkrankenhaus Berlin Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
Berlin, 12683
Klinikum Stuttgart - Olgahospital
Stuttgart, D-70176
Poland2 sites
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30-663
Szpital Dzieciecy im.prof.dr.med Jana Bogdanowicza, Oddzial Chirurgii i Urologii Dzieciecej z Pododdzialem Leczenia Oparzen
Warsaw
Romania2 sites
Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"
Iași, 700309
Spitalul Clinic de Urgenta Tg- Mures
Târgu Mureş, 54000
Spain2 sites
La Paz University Hospital
Madrid, 28046
Boulevar Sur s/n
Valencia, 46026
Ukraine2 sites
CNPE "City clinical hospital of immediate and urgent medical aid n.a.Meshchaninov" of Kharkiv CC and State institution 'Zaitsev V.T. Institute of general and urgent surgery of the National academy of medical sciences of Ukraine'
Kharkiv, 61103
Communal institution "Odessa Regional Clinical Medical Center"
Odesa, 65049
United Kingdom2 sites
Birmingham Children´s Hospital NHS Foundation Trust
Birmingham
Royal Manchester Children's Hospital
Manchester, M13 9WL
Belgium1 site
University Hospital, Department of Plastic Surgery
Ghent, B 9000
Italy1 site
Universitary Integrated Hospital Verona (AOUI Verona),
Verona, 37126
Netherlands1 site
Acute Burn Care &Trauma Surgery, Dept Surgery/Burn Center, Rode Kruis Ziekenhuis, LUMC University Leiden
Beverwijk, 1942
Slovakia1 site
Univerzitná nemocnica Bratislava, Klinika popálenin a rekonštrukčnej chirurgie
Bratislava, 826 06
About this study
Official title: A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
Read the detailed description
A total of 160 patients will be randomized into NexoBrid and SOC treatment (80 patients per arm).
Age distribution will be managed as follows:
- 45 patients 0-23 months old
- 45 patients 24 months-3 years old
- 30 patients 4-11 years old
- 20 patients 12-17 years old The remaining 20 patients will be enrolled to any of the above groups, per their age during enrollment.
The study will be conducted in three stages. In Stage I, at least 24 children age 4-18 years, hospitalized in burn units, with deep partial thickness burns ranging from 1%-30% TBSA, and who meet the entrance criteria, will be enrolled. Upon completion of stage I, a safety analysis will be performed on safety parameters and the results will be evaluated by a Data Safety Monitoring Board (DSMB) as defined in the agreed charter. If the DSMB does not have any safety concerns, Stage II will commence, this time enrolling at least 26 additional children aged of 1-18 years according to the study procedures. A DSMB will be convened to assess the safety data of the first 50 patients enrolled at stages 1 \& 2. If the DSMB has not found any safety concerns, stage III will commence in which patients from the age of birth to 18 years will be included (stage III will include 110 remaining patients required to reach a total of 160 patients).
Following the enrollment of a subject to the study and prior to randomization, physicians will define one or more Target Wounds (TWs) per subject according to TWs definition. All subjects' DPT and FT burns that fit the specified criteria are intended to receive study treatment per randomized study arm and therefore, must be designated as TWs.
Prior to eschar removal treatment with NexoBrid or SOC subjects will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions. Following wound cleansing and antibacterial treatments, subjects will undergo the eschar removal process as per treatment assignment (NexoBrid or SOC, following randomization). Subsequent to eschar removal, all wounds will be assessed and treated in the same manner, in accordance with post-eschar removal wound care strategy. Furthermore, subjects will undergo daily assessments (Vital signs (VS) and pain assessments) for one week and weekly assessments thereafter, until wound closure. Following wound closure, subjects will be followed up at 6 weeks, 12 weeks, and after that, at 6, 12, 18 and 24 months (for a blinded assessment of cosmesis, function and QoL evaluation).
All subjects will be invited to one additional extended follow up visit that will occur at least 30 months after wound closure confirmation for a blinded assessment of cosmesis, function and QoL evaluation.
- Conditions
- Thermal Burns
- Being tested
- NexoBrid, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexoBridDrug
NexoBrid is an enzymatic debriding agent for Eschar Removal.
Standard of CareProcedure or surgery
Surgical or Non-Surgical methods for Eschar Removal
| Study group | Role | What they receive |
|---|---|---|
| NexoBrid Gel | Experimental | 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. Receives: Drug: NexoBrid |
| Standard of Care | Active comparator | Non surgical and Surgical Debridement Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Eschar Removal (in Days)
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)
Measured: 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.
Secondary outcomes (4)
Incidence of Surgical Excision Performed for Eschar Removal
Number of patients who needed surgical excision for eschar removal
Measured: 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.
Blood Loss Related to Eschar Removal
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.
Measured: 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
Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level.
Percent area of deep partial thickness wounds autografted
Measured: Assessment will be performed by the investigator immediately after each autograft procedure was performed, before application of coverage.
Incidence of Autograft Performed in Deep Partial Thickness Wounds
Number of autografts performed in deep partial thickness wounds
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionApr 2021
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thermal BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lior Rosenberg, Prof., Study chair, MediWound LtdYaron Shoham, Dr., Study director, MediWound Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278718
- Sponsor's protocol ID
- MW2012-01-01
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2014
- Last updated
- 27 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.
PubMed 24074719Shoham Y, Rosenberg L, Narayan RP, Staubach R, Bene R, Kakola M, Monstrey SJ, Wilson Y, Jha M, Lewis GM, Larson S, Singer AJ. Open label randomized controlled trial of the efficacy and safety of NexoBrid compared to standard of care in children with burns. Burns. 2025 May;51(4):107417. doi: 10.1016/j.burns.2025.107417. Epub 2025 Feb 5.
PubMed 40117996
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment
- ClinicalTrials.gov ID
- NCT02278718
- Acronym / sponsor ID
- MW2012-01-01
- Conditions
- Thermal Burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 27 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
Detailed description
A total of 160 patients will be randomized into NexoBrid and SOC treatment (80 patients per arm).
Age distribution will be managed as follows:
- 45 patients 0-23 months old
- 45 patients 24 months-3 years old
- 30 patients 4-11 years old
- 20 patients 12-17 years old The remaining 20 patients will be enrolled to any of the above groups, per their age during enrollment.
The study will be conducted in three stages. In Stage I, at least 24 children age 4-18 years, hospitalized in burn units, with deep partial thickness burns ranging from 1%-30% TBSA, and who meet the entrance criteria, will be enrolled. Upon completion of stage I, a safety analysis will be performed on safety parameters and the results will be evaluated by a Data Safety Monitoring Board (DSMB) as defined in the agreed charter. If the DSMB does not have any safety concerns, Stage II will commence, this time enrolling at least 26 additional children aged of 1-18 years according to the study procedures. A DSMB will be convened to assess the safety data of the first 50 patients enrolled at stages 1 \& 2. If the DSMB has not found any safety concerns, stage III will commence in which patients from the age of birth to 18 years will be included (stage III will include 110 remaining patients required to reach a total of 160 patients).
Following the enrollment of a subject to the study and prior to randomization, physicians will define one or more Target Wounds (TWs) per subject according to TWs definition. All subjects' DPT and FT burns that fit the specified criteria are intended to receive study treatment per randomized study arm and therefore, must be designated as TWs.
Prior to eschar removal treatment with NexoBrid or SOC subjects will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions. Following wound cleansing and antibacterial treatments, subjects will undergo the eschar removal process as per treatment assignment (NexoBrid or SOC, following randomization). Subsequent to eschar removal, all wounds will be assessed and treated in the same manner, in accordance with post-eschar removal wound care strategy. Furthermore, subjects will undergo daily assessments (Vital signs (VS) and pain assessments) for one week and weekly assessments thereafter, until wound closure. Following wound closure, subjects will be followed up at 6 weeks, 12 weeks, and after that, at 6, 12, 18 and 24 months (for a blinded assessment of cosmesis, function and QoL evaluation).
All subjects will be invited to one additional extended follow up visit that will occur at least 30 months after wound closure confirmation for a blinded assessment of cosmesis, function and QoL evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NexoBrid Gel | Experimental | Drug: NexoBridNexoBrid 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. |
| Standard of Care | Active comparator | Procedure: Standard of CareNon surgical and Surgical Debridement |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Stage 1: Males and females between 4 years to 18 years of age, Stage 2 (upon DSMB review): Males and females between 1 year to 18 years of age, Stage 3 (upon DSMB review): Males and females between 0 years to 18 years of age.
- Thermal burns caused by fire/flame, scalds or contact.
- Patient total burns area ≥ 1% DPT and / or FT,
- Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
- Signed written informed consent by a legal guardian can be obtained within 84 hours of the burn injury.
Key exclusion criteria (27 listed)
- Patients weighing less than 3kg,
- Patients who are unable to follow study procedures and follow up period,
- Patients with electrical or chemical burns,
- Patient with a continuous burn area above 15% TBSA,
- Patients with no DPT and/or FT burn area (only SPT wounds),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexoBridNexoBrid is an enzymatic debriding agent for Eschar Removal. | Drug | NexoBrid Gel |
| Standard of CareSurgical or Non-Surgical methods for Eschar Removal | Procedure or surgery | Standard of Care |
Primary outcome
Time to Complete Eschar Removal (in Days)
Time frame: 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)
4 secondary outcomes
Incidence of Surgical Excision Performed for Eschar Removal
Time frame: 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.
Blood Loss Related to Eschar Removal
Time frame: 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
Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level.
Time frame: Assessment will be performed by the investigator immediately after each autograft procedure was performed, before application of coverage.
Incidence of Autograft Performed in Deep Partial Thickness Wounds
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24074719Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.
- Derived from this study: PubMed 40117996Shoham Y, Rosenberg L, Narayan RP, Staubach R, Bene R, Kakola M, Monstrey SJ, Wilson Y, Jha M, Lewis GM, Larson S, Singer AJ. Open label randomized controlled trial of the efficacy and safety of NexoBrid compared to standard of care in children with burns. Burns. 2025 May;51(4):107417. doi: 10.1016/j.burns.2025.107417. Epub 2025 Feb 5.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lior Rosenberg, Prof. study chair
MediWound Ltd
Yaron Shoham, Dr. study director
MediWound Ltd
36 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NexoBrid in people with Thermal Burns, run by MediWound Ltd at 36 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Hungary, India, Germany, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Eschar Removal (in Days) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.