Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
研究概览
简要总结
The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.
详细描述
Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit site of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Healthy adult volunteers.
排除标准
- •History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex
研究组 & 干预措施
Whole group of 48 volunteers
The arm is composed of 48 human volunteers to test 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City), Hypochlorite 10% of electrochemical production (Exsept 10% ®, Pisa, Guadalajara, Mexico), and control.
干预措施: WHOLE GROUP OF 48 VOLUNTEERS (Other)
结局指标
主要结局
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
时间窗: 24 hours
Bacterial colony count of skin cultures to determine antiseptic properties
Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
时间窗: 24 hours
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial Colony Forming Units for the Control Period
时间窗: 24 hours
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
次要结局
- Presence of Skin Reactions for the 10% Povidone-iodine Period(24 hours)
- Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period(24 hours)
研究者
Alejandro E. Macias
Profesor de tiempo completo
Universidad de Guanajuato