A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 17
Updated:3/10/2019
Start Date:November 2014
End Date:December 2022
Contact:Aya Ben Yaakov, Dr.
Email:ayaby@mediwound.com
Phone:+972-77-971-4173

Use our guide to learn which trials are right for you!

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).

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).

Inclusion Criteria

1. 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.

2. Thermal burns caused by fire/flame, scalds or contact.

3. Patient total burns area ≥ 1% DPT and / or FT,

4. Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,

5. 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:

1. Wound that is ≥ 1% TBSA (DPT and/or FT) (not including face, perineal or genital),

2. 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,

3. Wound that is potentially intended for surgical eschar removal,

4. Wound's blisters can be unroofed, as judged by the investigator.

Exclusion Criteria:

1. Patients weighing less than 3kg,

2. Patients who are unable to follow study procedures and follow up period,

3. Patients with electrical or chemical burns,

4. Patient with a continuous burn area above 15% TBSA,

5. Patients with no DPT and/or FT burn area (only SPT wounds),

6. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA
(Circumferential is defined as encircling ≥ 80% of the trunk circumference),

7. The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),

8. Patients with diagnosed infections,

9. Diagnosis of smoke inhalation injury,

10. 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),

11. Patients with pre-enrolment escharotomy,

12. Pregnant women (positive pregnancy test) or nursing mothers,

13. Poorly controlled diabetes mellitus (HbA1c>9%),

14. Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases,
broncho-pneumonia, uncontrolled asthma,

15. Known conditions which interfere with circulation (peripheral vascular disease, edema,
lymphedema, surgery to the regional lymph nodes, obesity),

16. 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),

17. ASA greater than 2

18. Chronic systemic steroid intake,

19. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or
papain,

20. Current (within 12 months prior to screening) suicide attempt,

21. Enrollment in any investigational drug trial within 4 weeks prior to screening,

22. Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for
males and >2 units for females) or drug abuse,

23. Prisoners and incarcerated

24. Patients who might depend on the clinical study site or investigator.

25. Patient expresses objection to participate in the study.

26. 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)

27. General condition of patient would contraindicate surgery
We found this trial at
10
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-8990
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
Phone: 352-273-8825
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Boston, Massachusetts 02114
Phone: 617-726-3575
?
mi
from
Boston, MA
Click here to add this to my saved trials
Gent,
Phone: 0032-(0) 9-332 2220
?
mi
from
Gent,
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-1304
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Phone: 215-519-3695
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85008
Principal Investigator: Kevin Foster, MD
Phone: 602-344-5141
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Phone: 206-744-3140
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Phone: 631-444-7857
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Tampa, Florida 33606
Phone: 813-404-0057
?
mi
from
Tampa, FL
Click here to add this to my saved trials