A multicenter, multinational, randomized, controlled, blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to Standard of Care treatment
- Conditions
- The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar earlier and reducing surgical needs in hospitalized subjects with thermal burns of 4-15% of Total Body Surface Area (TBSA).MedDRA version: 17.0Level: HLTClassification code 10043418Term: Thermal burnsSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2014-001672-55-RO
- Lead Sponsor
- MediWound Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
1.Males and females; = 18 and = 70 years of age,
2.Thermal burns caused by fire/flame, scalds or contact,
3.Patient total burns area should be between 4% to 15% TBSA (= 4% and = 15% ; SPT, DPT and/or FT in depth),
4.Informed consent can be obtained within 48 hours of the burn injury.
5.Patients who are willing and able to sign a written consent form.
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 intended for surgical eschar removal,
4.Wound’s blisters can be 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
1.Patients who are unable to follow study procedures and follow up period,
2.Modified Baux index = 80,
3.Patients with burned, charred fingers, 3rd degree in depth, possibly devoid of circulation,
4.Patients with > 15% TBSA burns,
5.Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid or Collagenase) will be excluded from the study,
6.Patients with electrical or chemical burns,
7.Patients with DPT and/or FT facial burn wounds from flame, flash, explosion >0.5% TBSA (scald and contact burns are allowed),
8.Patients with circumferential DPT and/or FT burns defined as Extremities at Risk (EAR) ,
9.The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
10.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 SSD treatment),
11.Patients with pre-enrollment escharotomy,
12.Patients with diagnosed infections as described in Section 11.2.3 of study protocol,
13.Any signs or history that may indicate smoke inhalation (e.g. flame burn to the upper body, 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.),
14.Pregnant women (positive pregnancy test) or nursing mothers,
15.Poorly controlled diabetes mellitus (HbA1c>9%) in patients with known diabetes as captured in the medical history,
16.Patients with BMI greater than 34.0 kg/m2,
17.ASA greater than 2 (see Appendix 15 in study protocol)
18.Cardio-pulmonary disease (MI within 6 months prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma),
19.Pre-existing diseases which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to regional lymph nodes, obesity, varicose veins),
20.Any 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, cardiovascular disorder, pulmonary disorder, liver disorder including post alcoholic abuse impaired function or neoplastic disease),
21.Chronic systemic steroid intake,
22.History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
23.Current (within 12 months prior to screening) suicide attempt,
24.Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc),
25.Enrollment in any investigational drug trial within 4 weeks prior to screening,
26.Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse ,
27.Prisoners and incarcerated.
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