Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries (NEXT)

This is an expanded access trial for Thermal Burn Read More

Inclusion Criteria patient level:

1. Males and females ≥ 18 years of age,
2. Thermal burns caused by fire/flame, scalds or contact,
3. Patient total burns area ≥ 1% DPT and / or FT with eschar that should be removed in SOC,
4. Patient total burns area to be treated should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
5. Informed consent can be obtained within 84h of the burn injury,

6. Patients who are willing and able to sign a written consent . Inclusion Criteria - Wound level

   • 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, with eschar that should be removed in SOC,
• Wound's blisters can be removed/ unroofed, as judged by the investigator.

Exclusion Criteria patient level:

1. Modified Baux index ≥ 80,
2. Patients with burned, charred fingers, 3rd degree in depth and possibly devoid of circulation,
3. Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid),
4. Patients with pre enrolment escharotomy,
5. Patients with electrical or chemical burns,
6. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
7. 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),
8. Patients with diagnosed infections as described in the protocol,
9. Diagnosis of smoke inhalation injury [12],
10. Pregnant women (serum positive pregnancy test) or nursing mothers,
11. Poorly controlled diabetes mellitus (HbA1c>11%) in patients with known diabetes as captured in the medical history,
12. BMI greater than 39.0 kg/m2 in patients with burns area of up to 15% TBSA or BMI greater than 34.0 kg/m2 in patients with burns area of more than 15% %TBSA,
13. American Society of Anesthesiologists (ASA) physical status classification system greater than 2
14. 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),
15. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins),
16. Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as 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),
17. Chronic systemic steroid intake,
18. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain.

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

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