NCT00824551Unknown1 期
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Burns conversion
研究概览
简要总结
The blinded RCTstudy aims to:
- Determine the effects of HBOT on burns conversion for patients who have fresh thermal burns injury using the LDI.
- Objectively determine the proportion of burns conversion in areas of partial thickness burns for early thermal burns injury in both arms of the RCT.
- Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α and TGF-β ( comparison between both arms and 2 assessment points).
- Study the effect of HBOT on haematological markers including procalcitonin ,albumin, lymphocyte counts, neutrophil count, and macrophage count.
- Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte and macrophage infiltration, burns depth assessment and vascular endothelial growth factor (VEGF) and inducible nitric oxide synthase (iNOS) .
- Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal burns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thermal burns injury less than 40% with areas of deep dermal/ full thickness burns.
- •Less than 24 hours from time of injury.
- •No inhalational injury (Nasoendoscopy and bronchoscopic diagnosis by burns centre medical team/ department of emergency medicine in SGH).
- •Age 21 years old and above and less than 60 years old.
- •Not intubated and not on inotropic support.
- •Understands and agrees to informed consent (approved by IRB SGH).
排除标准
- •Untreated pneumothorax
- •Medications: Bleomycin, Cis-platin, Doxorubicin, Disulfiram (Chemotherapy)
- •Acute uncontrolled medical condition or significant medical condition (eg. Cerebrovascular accident, diabetic ketoacidosis, severe hypertensive 180/ 110 mmHg, end stage renal failure, chest pain, bleeding gastrointestinal tract, coma and acute asthma attack)
- •Other surgical emergencies (eg. open fractures, compartment syndrome and acute abdomen)
结局指标
主要结局
Burns conversion
时间窗: 2 years
次要结局
- Bacteriology culture and immunology markers(2 years)
研究者
研究点 (2)
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