CTRI/2010/091/000262Not Applicable2 期
Feasibility Study: Enzymatic Debridement in Patients with Partial Thickness Burns
MediWound, Ltd. 42 Hayarkon Street North Industrial Area MediWound, Ltd.Yavne, Israel 81227 Tel: 972-8-9324010 Fax: 972-8-93240110 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
- •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,
研究者
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