IRCT20080728001031N36尚未招募2 期
Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second-degree burn wounds: clinical trial phase II
ATI tech pharmed0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
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
- 年龄范围
- 18 years 至 70 years（—）
- 性别
- All
入选标准
- •Age between 18-70 years
- •Acute second-degree heat burns involving 20-50% of the body surface
- •Existence of at least three deep second-degree burn wound with 60 cm2 in area in the trunk or limbs (except the joints and arms & feet) in which tendons, blood vessels, or bone tissue is not exposed
- •Declaration of written consent to participate in the study and willingness to attend regular treatment and follow-up course
排除标准
- •Chronic uncontrolled underlying disease (vascular disease, diabetes, malnutrition, hypertension, cardiovascular disease)
- •Known underlying psychiatric illness
- •Pregnancy or breastfeeding
- •History of cancer or chemotherapy
- •Infection with viral diseases (HCV, HBV, HIV)
- •History of organ transplantation or blood transfusion
- •History of taking immunosuppressive or cytotoxic drugs during the last 6 months
- •Respiratory injury
- •Requires special care
- •Multiple trauma (fracture, or thoracic, abdominal, or CNS trauma)
研究者
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Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second degree burn woundsCondition 1: Acute second-degree burn wound on the upper limbs. Condition 2: Acute second degree burn wound in trunk. Condition 3: Acute second-degree burn wound on the lower limbs. Condition 4: Acute second degree burn wound involving 25-40% of body surface. Condition 5: Acute second degree burn wound involving 25-40% of body surface.Burn of second degree of shoulder and upper limb, except wrist and handBurn of second degree of trunkBurn of second degree of lower limb, except ankle and footBurns involving 20-29% of body surfaceBurns involving 30-39% of body surfaceT22.2T21.2T24.2T31.2T31.3IRCT20080728001031N31ATI tech pharmed5
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