DRKS00000006已完成4 期
Skin Disinfection with Octenidine Dihydrochloride for the Prevention of Catheter-associated Infections ? A Double-Blind, Randomised, Controlled Trial
niversitätsklinik Freiburg0 个研究点目标入组 400 人开始时间: 2008年8月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients >18 years and medical indication for CVC with a planned duration of minimum 5 days. Patient´s (or relative´s if applicable) written informed consent
排除标准
- •Known sensitisation against the proposed antiseptics, tunneled or implanted CVCs (e.g. Hickman Catheter), administration of antimicrobial drugs for therapy (not prophylaxis) less than one week prior to catheterization, pre-existing bloodstream infection (i.e., fever and/or other signs of infection, positive blood culture), terminal patients with limited therapy options and patients with burns, patients participating in a clinical trial on other antiseptics within a period of four weeks prior to inclusion date, patients with missing written consent
研究者
相似试验
已完成
4 期
Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine DihydrochlorideCatheterization, Central VenousCatheter-Associated InfectionsBacterial InfectionsBacteremiaNCT00515151University Hospital Freiburg400
进行中（未招募）
不适用
Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve-week comparison versus local treatment with Ringer solutionA randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase III b study - not availableEUCTR2006-001855-37-HUSchülke & Mayr GmbH240
进行中（未招募）
不适用
Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve-week comparison versus local treatment with Ringer solutionA randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase III b study - not availableChronic leg ulcersMedDRA version: 9.1Level: LLTClassification code 10066677Term: Chronic leg ulcerEUCTR2006-001855-37-GBSchülke & Mayr GmbH240
进行中（未招募）
不适用
Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve-week comparison versus local treatment with Ringer solutionA randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase III b study - not availableChronic venous leg ulcers In Germany, approximately three million people suffer from chronic leg ulcers of various origins. These ulcers are often very painful and extremely cost-intensive diseases associated with severe reductions of the patients’ quality of life. Vascular ulcers represent 75% of all chronic ulcers in general and are divided into venous (65%) - which is the study indication - and arterial and mixed arterial-venous ulcers (10%).MedDRA version: 9.1Level: LLTClassification code 10066677Term: Chronic leg ulcerEUCTR2006-001855-37-DESchülke & Mayr GmbH240
进行中（未招募）
1 期
Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve week comparison versus local treatment with Ringer solution. A randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase IIIb studyChronic leg ulcersMedDRA version: 9.1Level: LLTClassification code 10066677Term: Chronic leg ulcerEUCTR2006-001855-37-FRSchülke & Mayr GmbH240