EUCTR2013-000057-44-SE进行中（未招募）不适用
Feasibility Study: Enzymatic Debridement in Patients (Adults) with Partial Thickness and Full Thickness Burns - Protocol MW 2008-09-03
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
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 18 years and 70 years of age
- •2. Thermal burns caused by fire/flame, scalds or contact
- •3. Partial Thickness (mid & deep dermal) and Full Thickness burn wounds = 4% and = 30% Total Body Surface Area (TBSA)
- •4. Total burn wounds = 30% TBSA
- •5. 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,
- •6. Signed written informed consent.
- •Are the trial subjects under 18? no
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Beaux index > 80
- •2. 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)
- •3. Electrical or Chemical burns
- •4. Deep partial thickness and/or full thickness facial burn wounds >0.5% TBSA; study treatment of facial burns is not allowed
- •5. 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
- •6. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling = 80% of the trunk circumference),
- •a. The following pre enrolment dressings: a. Flamacerium,
- •b. Silver Nitrate (AgNO3), 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)
- •8. Pre-enrolment escharotomy
- •9. Heavily contaminated burns or pre-existing infections as determined by the treating physician/investigator based on a combination of parameters such as temperature (=39°C) WBC (= 20.0 X 103 cells/µL) and and wound discharge.
- •10. Any signs or history that may indicate smoke inhalation (e.g. flame burn to the upper body, flames in enclosed space, smoke and fumes on the patient and in mouth and nostrils, deep flame burns >1 %TBSA to the face, cough, hoarseness, stridor or breathing difficulty including tachypnea possibly related to smoke inhalation, etc.),
- •11. Prisoners
- •12. Pregnant women (positive pregnancy test) or nursing mothers
- •13. Poorly controlled diabetes mellitus (HbA1c>9%)
- •14. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases)
- •15. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins)
- •16. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease)
- •17. Chronic systemic steroid intake
- •18. History of allergy and/or known sensitivity to pineapples or papain
- •19. Current suicide attempt
- •20. Participation in another investigational drug trial
- •21. Current alcohol or drug abuse
研究者
相似试验
Unknown
2 期
Feasibility Study: Enzymatic Debridement in Patients with Partial Thickness BurnsCTRI/2010/091/000262MediWound, Ltd. 42 Hayarkon Street North Industrial Area MediWound, Ltd.Yavne, Israel 81227 Tel: 972-8-9324010 Fax: 972-8-932401112
未知
不适用
Can an enzyme-rich malt extract improve the symptoms of irritable bowel syndrome?Irritable Bowel Syndrome (IBS)Digestive SystemIrritable bowel syndromeISRCTN14173715Swansea Bay University Health Board50
已完成
不适用
A Study to Evaluate the Effect of Enzyme-treated Royal Jelly Consumption on the Index of Hematopoietic Stem Cell Count in Healthy SubjectsJPRN-UMIN000042951Yamada Bee Company, Inc.80
尚未招募
不适用
Pain Control after Root Canal TreatmentCTRI/2019/08/020507Pratyasha Kaushik
终止
Unknown
Juvia being used for irritable bowel syndromeIrritable bowel syndrome (IBS)Digestive SystemIrritable bowel syndromeISRCTN14003582Ateria Health Ltd9