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Feasibility Study: Enzymatic Debridement in Patients with Partial Thickness Burns

Phase 2
Registration Number
CTRI/2010/091/000262
Lead Sponsor
MediWound, Ltd. 42 Hayarkon Street North Industrial Area MediWound, Ltd.Yavne, Israel 81227 Tel: 972-8-9324010 Fax: 972-8-9324011
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Applicable
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

1. Males and females between 18 years and 55 years of age,
2. Thermal burns caused by fire/flame, scalds or contact,
3.Burn composition must be as follows:
a. Partial Thickness (mid & deep dermal) burn wounds ≥ 4% and ≤ 30% Total Body Surface Area (TBSA),
b. Full thickness burns ≤ 5%,
4. All the partial and full thickness burn wounds must receive study treatment except facial, genital or perineal burns (Exclusion Criteria #5 and #6, below),
5.Total burn wounds ≤ 30% TBSA,
6.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,
7. Signed written informed consent.

Exclusion Criteria

1. More than 5% TBSA full thickness burns,
2. Patient having only full thickness burns,
3. Other severe cutaneous trauma at the same sites as the burns (i.e. considerable blunt, avulsion or deep abrasion), or previous burn(s) at the same treatment site(s),
4. One or more burn wounds that do not meet study criteria,
5. Deep partial thickness and/or full thickness facial burn wounds >0.5% TBSA;
study treatment of facial burns is not allowed,
6. Study treatment of perineal and/or genital burns is not allowed; 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. A. The following pre enrolment dressings: a. Flamacerium, b. Silver Nitrate
(AgNO3),
B. Pre-enrolment wounds which are covered by eschar heavily saturated with
iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment);
9. Pre-enrolment escharotomy,
10. Heavily contaminated burns or pre-existing infections (WBC ≥ 20.0 X 103
cells/µ L),
11. Signs that may indicate smoke inhalation (e.g. clinical signs, etiology of injury, venue of injury, etc.),
12. Prisoners,
13. Pregnant women (positive pregnancy test) or nursing mothers,
14. Poorly controlled diabetes mellitus (HbA1c>9%),
15. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary
hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
16. Pre-existingdiseaseswhichinterferewithcirculation(PVD,edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
17. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),
18. Chronic systemic steroid intake,
19. History of allergy and/or known sensitivity to pineapples or papain,
20. Current suicide attempt,
21. Participation in another investigational drug trial,
22. Current alcohol or drug abuse,

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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