Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

Conditions: Burn wounds defined as deep partial thickness or full thickness thermal burns.

Registration Number: EUCTR2005-003662-41-DE

Lead Sponsor: MediWound Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

1. Males and females between 4 years to 55 years of age,
2. Thermal burns caused by fire/flame, scalds or contact,
3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds
> or = 5% and < or = 30% Total Body Surface Area (TBSA); all these wounds
must receive study treatment,
4. At least one wound of > or = 2% TBSA deep partial thickness and/or full thickness
burn,
5. At least 50% of the deep partial thickness and/or full thickness burn wound area
of the patient is intended for surgical debridement as judged at hospital
admission,
6. Total burn wounds < or = 30% TBSA,
7. Hospital admission within 24 hours of the burn injury. Patients transferred from
another hospital/clinic may be enrolled if the primary admission was within 24
hours of the burn injury and admission to the burn unit participating in the study
was within 48 hours of the burn injury,
8. Signed written informed consent.
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion
or deep abrasion) or previous burn(s) at the same treatment site(s) or one or
more burn wounds that do not meet study criteria,
2. Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA;
study treatment of facial burns is not allowed,
3. Study treatment of perineal and/or genital burns (A patient with these wounds
may be enrolled but the wounds may not be designated as target wounds.),
4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15%
TBSA, (Circumferential is defined as encircling > or = 80% of the trunk
circumference.)
5. A. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate
(AgNO3),
B. Pre-enrollment wounds which are covered by eschar heavily saturated with
iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
6. Pre-enrollment escharotomy,
7. Heavily contaminated burns or pre-existing infections (Adults: WBC > or = 20.0 x 103
cells/µL; Children aged 4-16: WBC > or = 25.0 x 103 cells/µL),
8. Signs that may indicate smoke inhalation,
9. General condition of patient would contraindicate surgery,
10. Prisoners,
11. Pregnant women (positive pregnancy test) or nursing mothers,
12. Poorly controlled diabetes mellitus (HbA1c>9%),
13. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary
hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
14. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema,
surgery to the regional lymph nodes, obesity, varicose veins),
15. Immediate life threatening conditions (such as immuno-compromising diseases,
life threatening trauma, severe pre-existing coagulation disorder, cardiovascular,
liver or neoplastic disease),
16. Chronic systemic steroid intake,
17. History of allergy and/or known sensitivity to pineapples or papain,
18. Current suicide attempt
19. Participation in another investigational drug trial,
20. Current alcohol or drug abuse.
21. Analgesic intake which prevents the patient from understanding the objectives,
nature and course of the study.