Enzymatic Debridement in Burns Patients (Children and Adults): A Comparision to Standard of Care (Protocol MW2004-11-02)
- Registration Number
- CTRI/2009/091/000413
- Lead Sponsor
- MediWound Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
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
≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive
study treatment,
4. At least one wound of ≥ 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 ≤ 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.
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 ≥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 ≥ 20.0 x 103 cells/μL; Children aged 4-16: WBC ≥ 25.0 x 103 cells/μL),
8. Signs that may indicate smoke inhalation,
9. Pregnant women (positive pregnancy test) or nursing mothers,
10. Poorly controlled diabetes mellitus (HbA1c>9%),
11. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
12. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
13. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular,
liver or neoplastic disease),
14. Chronic systemic steroid intake,
15. History of allergy and/or known sensitivity to pineapples or papain,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two co-primary endpoints are:<br>(1) The % treated wound excised (by tangential/minor/Versajet excision) or<br>dermabraded, in first surgery. Wounds which are entirely full thickness or<br>have full thickness areas are excluded from this analysis.<br>Surgical excision/dermabrasion performed in first surgery is defined as<br>tangential/minor/Versajet excision or dermabrasion, performed (a) as the<br>initial eschar removal (debridement) procedure in the surgical SOC group,<br>or (b) as the first surgical debridement performed after initial eschar<br>removal (debridement), in the DGD or non-surgical debridement (NSD)<br>SOC groups.<br>(2) The % treated wound autografted of deep partial wounds where the<br>potential tissue-sparing effect may be seen. The first post-debridement<br>autograft performed will be taken. Wounds which are entirely full<br>thickness or have full thickness areas are excluded from this analysisTimepoint: After completion of 152 patients (Point for Interim Analysis)
- Secondary Outcome Measures
Name Time Method The secondary end points are:<br>&#61623; The % treated wound excised (by tangential/minor/Versajet excision) or<br>dermabraded, in first surgery (as described above), for all wounds.<br>&#61623; Time to complete wound closure<br>&#61623; Timely eschar removal (debridement)<br>&#61623; Blood lossTimepoint: After completion of 240 patients