NCT04235985已完成4 期
Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following
Molnlycke Health Care AB2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年1月23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
- 26
- 试验地点
- 2
- 主要终点
- Chlorhexidine skin levels
研究概览
简要总结
This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. The amount of recovered CHG that resides on the skin following each of the evaluated application times will be evaluated via high performance liquid chromatography with ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
This is a cross-over design study where it will only be possible to mask the Outcomes Assessor
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be at least 18 years of age and can be of either sex and of any race.
- •Subjects must be able to read and understand English.
- •Subjects must possess both forearms and have a minimum forearm length (wrist crease to elbow crease) of 8.25 inches [21 cm].
- •Subjects must be in good general health (i.e., no current or recent severe illness) and have no medical diagnosis of mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B or C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.
排除标准
- •Participation in a clinical study within 7 days of participating in this study or current participation in another clinical study.
- •Presence of tattoos, active skin rashes, dermatoses, or breaks in the skin of the forearms or hands. Subjects must also have no inflammatory skin conditions (such as atopic dermatitis / eczema, contact dermatitis, or psoriasis) anywhere on the body.
- •Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances (e.g., colognes or perfumes), cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate (CHG).
- •Have experienced hives (raised welts) as a reaction to anything that contacted the skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
- •Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
- •Any prosthetic device or joint (e.g., pins, screws, plates, or rods) installed in the arms within the last 6 months.
- •Any type of indwelling port or Peripherally-Inserted Central Catheter (PICC).
- •Subject is pregnant, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or is nursing a child.
- •Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation.
结局指标
主要结局
Chlorhexidine skin levels
时间窗: range from 15 to 120 seconds
To find out how much CHG is left on the skin with different application times
次要结局
未报告次要终点
研究者
研究点 (2)
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