NCT01153620已完成4 期
Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Reduction (log10) in Colony Forming Units
研究概览
简要总结
The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with acute traumatic cut, crush, abrasion, bite or stab wounds Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations
- •Wounds that are a minimum of approximately 4 cm2 in size
- •Ability to read and understand the German patient information sheet and informed consent form
排除标准
- •< 18 years of age
- •Pregnancy
- •Immunosuppression
- •Wounds caused by a burn
- •Wounds that require treatment of hyaline cartilage, the central nervous system, peritoneum, meningae, inner / middle ear or inner eye
- •Simultaneous participation in another clinical trial
- •Wounds that require immediate surgical or medical treatment as well patients who are critically ill
- •Patient with a known allergy to the active agent or any of the excipients
- •Wounds that are >3 cm in depth
- •Wounds that have not received medical treatment for ≥6 hours
- •Heavily bleeding wounds
- •Open fractures, joints or tendons
- •Wounds of the face
研究组 & 干预措施
Ringer's Solution
Placebo Comparator
干预措施: Ringer's Solution (Other)
Lavasept 0.04%
Active Comparator
干预措施: Lavasept 0.04% (Drug)
结局指标
主要结局
Reduction (log10) in Colony Forming Units
时间窗: 60 minutes
Comparison of the log10 reduction in CFU after 60 minutes of treatment application.
次要结局
- Reduction in CFU(15 minutes, 30 minutes and 60 minutes)
- Local Tolerability: Pruritis Burning(60 minutes)
- Comparison of the Percentage of Patients With Target Wounds <50 CFU(60 minutes)
研究者
研究点 (1)
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