NCT01112020已完成1 期
Components & Tolerability of Chlorhexidine Gluconate Dressing Patch Compared to BioPatch & Tegaderm Chlorhexidine Gluconate Securement Dressing After Application to Healthy Subjects Over a 7-day Period
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Chlorhexidine gluconate (CHG) level
研究概览
简要总结
The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.
详细描述
To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- 是
入选标准
- •Able to read, review and sign the Informed Consent
- •Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
- •Use study-approved contraceptive methods
排除标准
- •Participation in an investigational study within 28 days prior to dosing.
- •Clinically significant illness within 28 days prior to dosing.
- •History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
- •History of clinically significant skin disorders
- •History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
- •History of significant dermatologic cancers (melanoma, squamous)
- •Known history of immunologic disorders
- •Use immunosuppressive or other proscribed medications
- •Use of skin products at the application site
- •Significant history of allergies to soaps, lotions, emollients, ointments, creams
- •History of drug or alcohol addiction within the past year
- •Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study
研究组 & 干预措施
Tegaderm CHG
Active Comparator
Tegaderm CHG IV Securement Dressing
干预措施: Tegaderm CHG (Device)
CHG Catheter Dressing Patch
Experimental
干预措施: CHG Catheter Dressing Patch (Device)
Biopatch
Active Comparator
Biopatch Protective Disk with CHG
干预措施: Biopatch (Device)
结局指标
主要结局
Chlorhexidine gluconate (CHG) level
时间窗: 1 week
CHG level in dressing after 7 days exposure to CHG-containing test articles
次要结局
- Parachloroaniline (PCA) level(7 days)
研究者
研究点 (1)
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