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
- Conditions
- burnsthermal burns1002211910040795
- Registration Number
- NL-OMON45033
- Lead Sponsor
- MediWound, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria- Patient level
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.;Inclusion Criteria - Wound level
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.
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 as described in Section 13.2.6 of study protocol,
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 preexisting coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),
17. ASA greater than 2 (see Appendix 13- ASA classification system in study protocol)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The below primary population will be investigated primarily at the subject<br /><br>level, on the ITT population.<br /><br>1. Earlier eschar removal (in days): Demonstrate superiority over SOC for<br /><br>eschar removal as measured by a survival analysis of incidence of complete<br /><br>eschar removal as a function of time. Eschar removal will be measured at the<br /><br>end of the debridement starting from randomization date.<br /><br>2. Reduction in surgical needs: Demonstrate superiority over SOC in reduction<br /><br>in surgical need for excisional eschar removal as measured by an analysis of %<br /><br>wound area surgically excised for eschar removal (tangential/ minor/ avulsion/<br /><br>Versajet and/or dermabrasion excision).<br /><br>3. Cosmesis and Function: Demonstrate non-inferiority to SOC in quality of<br /><br>scars of burns (using POSAS) treated with NexoBrid, measured at 24 months from<br /><br>wound closure.</p><br>
- Secondary Outcome Measures
Name Time Method