Thermal BurnNEXTNCT04040660
Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries
A study testing NexoBrid in people with Thermal Burn, run by MediWound Ltd at 28 sites in United States.
Trial summary
Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Thermal Burn
- What is being tested?
- NexoBrid
- How many people
- Not given
- Where
- 28 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Pediatric only (0 to < 18years old) males and females
- Thermal burns caused by fire/flame, scalds or contact,
- Patient total burns area ≥ 1% DPT and / or FT with eschar that should be removed in SOC,
- Patient total burns area to be treated should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
- Informed consent can be obtained within 84h of the burn injury,
- Patients and/or legal authorized representative who are willing and able to sign a written consent .
Show all 10Show fewer
- At least one wound (a continuous burn area) that is ≥0.5% TBSA (DPT and/or FT) (this minimal wound size should not include face, perineal or genital)
- All planned TWs should meet the following criteria:
- SPT areas that cannot be demarcated from DPT and FT areas should be less than 50% of the % TBSA of the TW,
- Wound's blisters can be removed/ unroofed, as judged by the investigator.
Who cannot join
- Patients weighing less than 3kg,
- Patients with burned, charred fingers, 3rd degree in depth and possibly devoid of circulation,
- Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid),
- Patients with pre enrolment escharotomy,
- Patients with electrical or chemical burns,
- The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
Show all 20Show fewer
- Patients with pre-enrolment wounds which are covered by eschar heavily saturated with Silver, Iodine or by SSD pseudoeschar (pseudoeschar as a result of > 12 hrs SSD treatment),
- Patients with diagnosed infections as described in the protocol,
- Diagnosis of smoke inhalation injury [12],
- Pregnant women (serum positive pregnancy test) or nursing mothers,
- Poorly controlled diabetes mellitus (HbA1c>11%) in patients with known diabetes as captured in the medical history,
- BMI greater than 40.0 kg/m2,
- American Society of Anesthesiologists (ASA) physical status classification system greater than 2
- Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable Ischemic Heart Disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma or uncontrolled asthma),
- Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins),
- Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as a positive COVID test, severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury),
- Chronic systemic steroid intake,
- History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain.
- Enrollment in any investigational drug trial within 4 weeks prior to screening.
- -
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Akron Children's Hospital
Akron, Ohio, 44308
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, 18103
Grady Memorial Hospital
Atlanta, Georgia, 30303
Johns Hopkins Bayview Medical Center, Burn Center
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Medical University of South Carolina
Charleston, South Carolina, 29425
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Parkland Health & Hospital System, Burn Center
Dallas, Texas, 75235
Shands Children's Hospital, University of Florida
Gainesville, Florida, 32610
University of Florida, Department of Surgery
Gainesville, Florida, 32610
Eskenazi Hospital
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
The University of Kansas Hospital
Kansas City, Kansas, 66160
Jackson Memorial Hospital
Miami, Florida, 33136
Colombia St Mary's Hospital
Milwaukee, Wisconsin, 53211
Hennepin Healthcare
Minneapolis, Minnesota, 55415
University of South Alabama
Mobile, Alabama, 36617
University Medical Center New Orleans
New Orleans, Louisiana, 70112
University of California, Irvine
Orange, California, 92868
Valleywise Health Medical Center
Phoenix, Arizona, 85008
UPMC Mercy Burn Center
Pittsburgh, Pennsylvania, 15219
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Legacy Oregon Burn Center
Portland, Oregon, 97227
University of Utah Hospital
Salt Lake City, Utah, 84132
Harborview Medical Center
Seattle, Washington, 98104
Stony Brook University Medical Center
Stony Brook, New York, 11794
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by previous clinical studies. The depth determination is important for the planning and execution of the post eschar removal stage of wound closure phase (grafting or spontaneous epithelialization).
Additional clinically meaningful attributes of NexoBrid enzymatic eschar removal is the ability to lower surgical burden as it allows to remove eschar in wounds that otherwise would have to undergo surgical excision as no other non-surgical treatment is available for early and effective eschar removal.
Read more
MediWound has completed the recruitment of patients to study MW2010-03-02 (DETECT Study). The timeline for patients' follow-up and potential for approval in 2021/2022, creates a significant gap in the ability of clinical practitioner's to maintain their knowledge and skills in using NexoBrid as they no longer treat eligible patients. The expanded access protocol will allow to expand treatment to additional patients in up to 30 US burn centers (DETECT sites and additional sites). The proposed protocol will allow product availability to eligible population and keep the clinical use of the product knowledge active in the burn care community introducing it to their routine burn care.
The BLA assessment was completed and NexoBrid is approved for use in adults in the US. Adult enrollment is closed, and only pediatric patients will continue to be recruited for this treatment protocol.
The purpose of this treatment protocol is to provide NexoBrid to patients with DPT and FT thermal burns on up to 30% TBSA.
This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in this patient population.
Read the detailed description
This is an Expanded Access (treatment) protocol to allow ongoing treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study).
This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from DPT and FT thermal burns.
Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the specified entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will further allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns.
Prior to initiation of eschar removal treatment, patients will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions according to product instruction for use in order to ensure clean and moist eschar covered wound bed for NexoBrid application. Vital signs (Blood Pressure, Heart Rate and temperature) measurements and pain assessment will be performed within 24 hrs before start of treatment as well as haematology, biochemistry blood tests \& PTT/INR. Pressure measurements for circumferential extremity wounds will be performed 1 hour before start of treatment and will be closely monitored during treatment. Following wound cleansing and soaking treatments, patients will undergo the eschar removal process. TWs of up to 15% total body surface area (TBSA) will be treated with a single application of NexoBrid for 4 hours. Patients with TWs >15% TBSA and up to 30% TBSA will be treated with 2 consecutive applications of 4 hours each. NexoBrid should not be applied to more than 15% TBSA in one session. PK samples will be taken from sub-set of patients with TWs area >15% TBSA. Pressure measurements for circumferential extremity wounds will be performed after the removal of NexoBrid.
Post eschar removal completion, patients will undergo daily vital signs (Blood Pressure, Heart Rate and temperature measurements) and pain assessments for 1 week, starting on the morning following start of eschar removal. Blood tests (haematology and biochemistry) will be performed 24 ± 6 hrs post eschar removal as well as PTT/INR. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed.
Cosmesis (scar quality) evaluation (using MVSS) will be performed at 3 and 12 months post wound closure confirmation visit.
- Conditions
- Thermal Burn
- Being tested
- NexoBrid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexoBridDrug
NexoBrid is presented as lyophilized powder and gel vehicle for preparation of a gel for cutaneous use. The API is a concentrate of proteolytic enzymes enriched in Bromelain extracted from the stem of Ananas comosus (pineapple plant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040660
- Sponsor's protocol ID
- MW2018-06-21
- Acronym
- NEXT
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2019
- Last updated
- 30 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries
- ClinicalTrials.gov ID
- NCT04040660
- Acronym / sponsor ID
- NEXT / MW2018-06-21
- Conditions
- Thermal Burn
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by previous clinical studies. The depth determination is important for the planning and execution of the post eschar removal stage of wound closure phase (grafting or spontaneous epithelialization).
Additional clinically meaningful attributes of NexoBrid enzymatic eschar removal is the ability to lower surgical burden as it allows to remove eschar in wounds that otherwise would have to undergo surgical excision as no other non-surgical treatment is available for early and effective eschar removal.
MediWound has completed the recruitment of patients to study MW2010-03-02 (DETECT Study). The timeline for patients' follow-up and potential for approval in 2021/2022, creates a significant gap in the ability of clinical practitioner's to maintain their knowledge and skills in using NexoBrid as they no longer treat eligible patients. The expanded access protocol will allow to expand treatment to additional patients in up to 30 US burn centers (DETECT sites and additional sites). The proposed protocol will allow product availability to eligible population and keep the clinical use of the product knowledge active in the burn care community introducing it to their routine burn care.
The BLA assessment was completed and NexoBrid is approved for use in adults in the US. Adult enrollment is closed, and only pediatric patients will continue to be recruited for this treatment protocol.
The purpose of this treatment protocol is to provide NexoBrid to patients with DPT and FT thermal burns on up to 30% TBSA.
This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in this patient population.
Detailed description
This is an Expanded Access (treatment) protocol to allow ongoing treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study).
This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from DPT and FT thermal burns.
Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the specified entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will further allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns.
Prior to initiation of eschar removal treatment, patients will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions according to product instruction for use in order to ensure clean and moist eschar covered wound bed for NexoBrid application. Vital signs (Blood Pressure, Heart Rate and temperature) measurements and pain assessment will be performed within 24 hrs before start of treatment as well as haematology, biochemistry blood tests \& PTT/INR. Pressure measurements for circumferential extremity wounds will be performed 1 hour before start of treatment and will be closely monitored during treatment. Following wound cleansing and soaking treatments, patients will undergo the eschar removal process. TWs of up to 15% total body surface area (TBSA) will be treated with a single application of NexoBrid for 4 hours. Patients with TWs >15% TBSA and up to 30% TBSA will be treated with 2 consecutive applications of 4 hours each. NexoBrid should not be applied to more than 15% TBSA in one session. PK samples will be taken from sub-set of patients with TWs area >15% TBSA. Pressure measurements for circumferential extremity wounds will be performed after the removal of NexoBrid.
Post eschar removal completion, patients will undergo daily vital signs (Blood Pressure, Heart Rate and temperature measurements) and pain assessments for 1 week, starting on the morning following start of eschar removal. Blood tests (haematology and biochemistry) will be performed 24 ± 6 hrs post eschar removal as well as PTT/INR. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed.
Cosmesis (scar quality) evaluation (using MVSS) will be performed at 3 and 12 months post wound closure confirmation visit.
Study design
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Pediatric only (0 to < 18years old) males and females
- Thermal burns caused by fire/flame, scalds or contact,
- Patient total burns area ≥ 1% DPT and / or FT with eschar that should be removed in SOC,
- Patient total burns area to be treated should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
- Informed consent can be obtained within 84h of the burn injury,
Key exclusion criteria (20 listed)
- Patients weighing less than 3kg,
- Patients with burned, charred fingers, 3rd degree in depth and possibly devoid of circulation,
- Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid),
- Patients with pre enrolment escharotomy,
- Patients with electrical or chemical burns,
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 presented as lyophilized powder and gel vehicle for preparation of a gel for cutaneous use. The API is a concentrate of proteolytic enzymes enriched in Bromelain extracted from the stem of Ananas comosus (pineapple plant) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
Related trials for Thermal Burn
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruitingPhase 1
Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline
Thermal Burn, Amitriptyline
RecruitingPhase 3
Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial
Burn Injury, Thermal Burn
RecruitingPhase 3
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Burns
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.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexoBrid in people with Thermal Burn, run by MediWound Ltd at 28 sites in United States.
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 20 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 30 Aug 2024.