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
干预措施
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
研究组 & 干预措施
Askina Calgitrol Paste
Experimental
干预措施: Askina Calgitrol Paste (Device)
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)
The quantification of the amount of silver found in plasma during the treatment
时间窗: Change from Baseline in Blood at 3 days
次要结局
- 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)
- Wound bed and periwound skin conditions(At each dressing change (an expected average of one day))
研究者
相似试验
已完成
不适用
Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)Atrial FibrillationNCT02168972Kardium Inc.60
招募中
3 期
A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Efficacy and Safety of Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth ExtractionBone Loss, AlveolarNCT05602493Xeolas Pharmaceuticals Limited60
已完成
不适用
Clinical study to investigate the safe and effective use of Stethoglove® by health care professionals under real-life conditionsPlacing a physical barrier between the patient and the stethoscope is one way to improve the protection of patients from germ transmission through the stethoscope.DRKS00025984Stethoglove GmbH54
已完成
3 期
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisNCT03971422UCB Biopharma SRL200
撤回
3 期
Efficacy and Safety Evaluation of 3K3A-APC in Ischemic StrokeIschemic StrokeNCT05484154ZZ Biotech, LLC1,400