Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Compared to Triclosan 1% / Isopropyl Alcohol 70%
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
研究概览
简要总结
Currently there are few options for skin antisepsis, commercially antiseptic triclosan is mainly used. To have more options, this study is necessary, where investigators will determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and choose the one with the best characteristics for skin antisepsis.
详细描述
2% chlorhexidine has been used as an antiseptic for invasive procedures, such as the skin preparation for surgery or insertion of intravascular catheters, thereby decreasing the incidence of infections. The preparation of the skin with antiseptics, helps mechanically clean the surface of the skin to be subjected to surgical intervention, removing fat, sweat, dead cells and kill bacteria that are in the skin. It has been shown that 2% chlorhexidine in solution with 70% isopropyl alcohol has greater activity than chlorhexidine in aqueous solution. The constant use of triclosan causes resistance of some microorganisms on some antibiotics.It has been shown that 0.5% of triclosan in 60% alcohol isopropyl chlorhexidine is more effective than alcohol. The aim of the study is to know if 2% chlorhexidine has more residual effect than triclosan 1%, both antiseptic diluted in 70% isopropyl alcohol.
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
- •Volunteers who have completed the stabilization phase of skin flora.
- •Volunteers who does not taken a shower or bath 24 hours before the test.
排除标准
- •Volunteers with a score below 100 Colony Forming Unit per square centimeter (CFU/cm2) of forearm skin surface in the control after the stabilization of the skin flora.
- •History of skin allergies or atopy, as well as reactions to alcohol, soaps, iodine, chlorine or latex.
研究组 & 干预措施
Whole group of 135 units of measurement
The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
- Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
- Other: Preparing skin's areas to be tested with two antiseptics and two controls
干预措施: Preparing skin's areas to be tested with two antiseptics and two controls (Other)
Whole group of 135 units of measurement
The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
- Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
- Other: Preparing skin's areas to be tested with two antiseptics and two controls
干预措施: Bacterial culture of the prepared skin's areas with two antiseptics and two controls (Other)
结局指标
主要结局
Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
时间窗: 24 hours
135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.
时间窗: 24 hours
135 determinations to test 1% triclosan in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
时间窗: 24 hrs
135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
次要结局
- Detect Presence of Allergy or Skin Reaction by the Antiseptic Application(24 hours)
研究者
Alejandro E. Macias
Principal Investigator
Universidad de Guanajuato