EUCTR2005-003662-41-SK进行中（未招募）1 期
Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 wounds or burn wound area of the patient is intended for tangential excision 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.
- •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
排除标准
- •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,
- •4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling = 80% of the trunk circumference.)
- •5. Pre-enrollment dressings other than: none, dry clean, moist clean, saline, Silver Sulphadiazine (SSD), or 3%-5% Sulfamylon,
- •6. Pre-enrollment escharotomy,
- •7. Heavily contaminated burns or pre-existing infections (Adults: WBC = 20.0 cells/µL; Children aged 4-16: WBC = 25.0 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, atopic disease or known sensitivity to pineapples or papain,
- •18. Suicide attempts,
- •19. Participation in another investigational drug trial,
- •20. Current alcohol or drug abuse.
研究者
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