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临床试验/EUCTR2005-003662-41-DE
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)

MediWound Ltd0 个研究点目标入组 270 人开始时间: 2005年12月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
MediWound Ltd
入组人数
270
研究概览入排标准研究者记录与标识符相似试验

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

发起方
MediWound Ltd

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Enzymatic Debridement in Burns Patients (Children &... | 临床试验