NCT01499264Unknown3 期
Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
Associazione Infermieristica per lo studio delle Lesioni Cutanee2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Wound healing and Significant reduction in pain
研究概览
简要总结
Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with burn injuries with particular regard to: 1) Wound healing (complete reepithelialization), 2) the patient's pain. In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the PSST.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one injury burn covered by a dressing of 10x8 cm (80 cm2)
- •Injury treated with medication in use at the center
- •Patients assisted at the emergency care, or at the outpatient
- •Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm)
- •Patient age greater than or equal to 18 years
- •Patients who have given consent to enrollment in the trial and the processing of personal data
- •Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (washout) of "no treatment" according to the research protocol
排除标准
- •A end-stage of disease
- •Suspected or known allergic diathesis to the product of medication
- •Subjects that do not give consent to data processing
- •Dry lesion with necrosis or eschar
- •Presence of both local and systemic infection or inflammation
- •Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol
- •Patient / lesion that has already been previously recruited into the study, before a period of 10 days (washout) of suspension from the same research protocol
- •Patients who use alternative medicine treatments such as aloe
结局指标
主要结局
Wound healing and Significant reduction in pain
时间窗: 1 month
次要结局
- Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit(1 month)
研究者
研究点 (2)
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