EUCTR2005-003662-41-DE进行中（未招募）不适用
Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
- •> 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
- •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
- •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
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 (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
- •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.
研究者
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