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: The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).; MedDRA version: 18.0Level: HLTClassification code 10043418Term: Thermal burnsSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2014-003066-24-SE
• Lead Sponsor: MediWound Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

8.1.1Inclusion Criteria- Patient level
1.Stage 1: Males and females between 4 years to 18 years of age,
Stage 2 (upon approval of DSMB): 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 should be between 1% to 30% TBSA (= 1% and = 30% ; SPT, DPT and/or FT in depth),
4.Signed written informed consent by a legal guardian can be obtained within 60 hours of the burn injury.
8.1.2Inclusion 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 (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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who are unable to follow study procedures and follow up period,
2.Patients with electrical or chemical burns,
3.Patient with a continuous burn area above 15% TBSA,
4.Patients with no DPT and/or FT burn area (only SPT wounds),
5.DPT and/or FT facial burn wounds from flame, flash, explosion >0.5% TBSA (scald and contact burns are allowed); study treatment of all facial burns is not allowed,
6.Study treatment of perineal and/or genital burns is not allowed; however, a patient with these wounds may be enrolled but the wounds may not be designated as target wounds,
7.Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling = 80% of the trunk circumference),
8.The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
9.Patients with diagnosed infections as described in Section ?13.2.5? of study protocol,
10.Any signs or history that may indicate smoke inhalation (e.g. flames in enclosed space, smoke and fumes on the patient and in mouth and nostrils, deep flame burns >0.5 %TBSA to the face, cough, hoarseness, stridor or breathing difficulty including tachypnea possibly related to smoke inhalation, etc.),
11.Patients with pre-enrolment wounds which are covered by eschar saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
12.Patients with pre-enrolment escharotomy,
13.Pregnant women (positive pregnancy test) or nursing mothers,
14.Poorly controlled diabetes mellitus (HbA1c>9%),
15.Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma),
16.Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
17.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 (see Appendix 13- ASA classification system in study protocol)
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified