A multicenter, multinational, randomized, controlled, assessor blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Gel Vehicle and compared to Standard of Care
- Conditions
- The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar in hospitalized subjects with thermal burns.MedDRA version: 19.0Level: HLTClassification code 10043418Term: Thermal burnsSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2014-001672-55-CZ
- Lead Sponsor
- MediWound Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
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 = 3% DPT and / or FT,
4. Patient total burns area should be = 30% TBSA; SPT, DPT and/or FT in depth,
5. Informed consent can be obtained within 84 hours of the burn injury.
6. Patients who are willing and able to sign a written consent form.
Inclusion Criteria - Wound level
1. 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 Target Wounds (TWs) should meet the following criteria:
1. SPT areas that cannot be demarcated from DPT and FT areas should be less than 50% of the % TBSA of the TW,
2. Wound’s blisters can be removed/ unroofed, as judged by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria- Patient level
1. Patients who are unable to follow study procedures and follow up period,
2. Modified Baux index4 = 80,
3. Patients with burned, charred fingers, 3rd degree in depth and possibly devoid of circulation,
4. Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid) will be excluded from the study,
5. Patients with electrical or chemical burns,
6. Patients with circumferential (>80% of the limb circumference) DPT and/or FT burns defined as Extremities at Risk (EAR) as described in section 11.8,
7. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
8. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of > 12 hrs SSD treatment),
9. Patients with pre-enrolment escharotomy,
10. Patients with diagnosed infections as described in Section 11.9 of study protocol,
11. Diagnosis of smoke inhalation injury,
12. Pregnant women (positive pregnancy test) or nursing mothers,
13. Poorly controlled diabetes mellitus (HbA1c>11%) in patients with known diabetes as captured in the medical history,
14. 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,
15. ASA greater than 2 (see Appendix 15 in study protocol)
16. Cardio-pulmonary disease (MI within 6 months prior to injury, 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),
17. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins),
18. Any conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as severe immunocompromising 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),
19. Chronic systemic steroid intake,
20. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
21. Current (within 12 months prior to screening) suicide attempt,
22. Mentally incapacitated adults who are incapable of giving legal consent,
23. Enrollment in any investigational drug trial within 4 weeks prior to screening,
24. Current (within 12 months prior to screening) severe alcohol or drug use disorder (see definition in section 1.1),
25. Prisoners and incarcerated,
26. Patients who might depend on the clinical study site or investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method