Comparative Study of 2% Chlorhexidine Gluconate in 70% Isopropyl Alcohol 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
- 30
- 试验地点
- 2
- 主要终点
- Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite
研究概览
简要总结
The physicians have few options for skin antisepsis. Alternatives for common use antiseptics are costly or ineffective. In order to have more options, this study is needed. The investigators want to know if there are differences between the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.
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 side 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. In a recent study perform by our group it was demonstrated that 10% sodium hypochlorite was not inferior than povidone-iodine.
It has been demonstrated as well that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior to povidone-iodine. The aim of this study is to know if 10% sodium hypochlorite has a similar effect that the best current option for skin antisepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（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, chlorine or latex
研究组 & 干预措施
Whole group of 30 volunteers
The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.
干预措施: Bacterial culture of the prepared skin's areas (Biological)
Whole group of 30 volunteers
The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.
干预措施: Preparing skin's areas to be tested (Other)
test group of substantivity
The arm is composed of 10 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City)
干预措施: Antiseptic substantivity (Biological)
结局指标
主要结局
Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite
时间窗: 24 hours
Compare decrease in colony forming units in cultures of samples taken with both antiseptics
次要结局
- Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol(24 hours)
- Bacterial count of skin cultures for the control 1(24 hours)
- Presence of allergy or any reaction at 24 hours after the antiseptic application.(24 hours)
- Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol(24 hours)
- Bacterial count of skin cultures for the 10% sodium hypochlorite(24 hours)
- Bacterial count of skin cultures for the control 2(24 hours)
- Evaluation of antiseptic substantivity(24 hours)
研究者
Alejandro E. Macias
MD
Universidad de Guanajuato