NCT01911858撤回3 期
Non-controlled Prospective Cohort Study of the Use of Askina® Calgitrol® Paste on III Degree Burns in Adults
BBraun Medical SAS0 个研究点开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- The quantification of the amount of silver found in plasma during the treatment
研究概览
简要总结
The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults (≥>18 years age). No upper age limit
- •III degree thermal burns from 2-30% TBSA as determined by the Rule of Nines
- •Patients who underwent initial treatment within 24 hours after the injury at the latest
- •Patients who underwent initial treatment directly at the Burn Centre of FNKV or the initial treatment was in accordance with the standard of care of the Centre
- •All patients will have been hospitalised
- •Patients who are capable of giving signing informed consent and have done so.
排除标准
- •Patients with electrical or chemical burns
- •Patients with already infected wounds
- •Patients taking systemic antibiotics on admission
- •Patients pregnant or lactating
- •Patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent
- •Patients who used or were treated with silver products for other reasons than treatment of the acute burn in the last 3 months
- •Patients whose other burn wounds are being treated with silver products.
- •Patients receiving renal dialysis
- •Known allergy or sensitivity to any of the ingredients in Askina® Calgitrol® Paste.
- •Simultaneous participation in another interventional clinical trial
结局指标
主要结局
The quantification of the amount of silver found in plasma during the treatment
时间窗: Change from Baseline in Blood immediately after the removal of the last investigational dressing (the day before necrotomy, an expected average between 3-10 days after inclusion)
次要结局
- Wound bed and periwound skin conditions(At each dressing change (an expected average of one day))
- Clinical signs of infection(At each dressing change (an expected average of one day))
- Patient comfort(At each dressing change (an expected average of one day))
- Number of dressing changes(At each dressing change (an expected average of one day))
- Adverse Events or Adverse device related event(At each dressing change)
研究者
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