Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04040660
Eligibility Criteria:
Inclusion Criteria patient level:
1. Pediatric only (0 to \< 18years old) males and females
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 and/or legal authorized representative 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,
* Wound's blisters can be removed/ unroofed, as judged by the investigator.
Exclusion Criteria patient level:
1. Patients weighing less than 3kg,
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 40.0 kg/m2,
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 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),
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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Sex:
ALL
Minimum Age:
0 Years
Study:
NCT04040660
Study Brief:
Protocol Section:
NCT04040660