Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
研究概览
简要总结
Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most frequently performed procedures worldwide, and despite the advancements of medical equipment, remain dependent on experience and practice of the anesthesiologists. Although antisepsis takes part of the daily routine, there are still no solid scientific evidence of the most appropriate antiseptic for these procedures.
Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin antisepsis for the neuraxial blocks.
Methods: This is a clinical trial, a prospective, randomized study. There will be selected, consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%, and to group B (n = 35), in which the antiseptic will be performed with the 0.5% chlorhexidine in alcoholic solution. Samples will be collected with swabs in an area of 25 cm² for bacterial cultures three times: in pre-antisepsis moments, in the second minute after antisepsis, and immediately after the puncture. The number of colonies forming units per square centimeter (CFU / cm²) will be counted. The data will be analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Patients between 18 and 65 years of age , without restriction as to sex, ethnicity, education or social class;
- •Patients who are undergoing neuraxial blockade by indicating the anesthesiologist responsible for the procedure
排除标准
- •comorbidities or conditions which constitute a contraindication for the neuroaxial block ;
- •Body mass index (BMI ) greater than 30 kg / m2;
- •Ongoing infection;
- •Use of antibiotics in the last seven days;
- •Skin lesions at the puncture site ;
- •Refusal to participate.
研究组 & 干预措施
Alcohol group
Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia
干预措施: alcohol antisepsis (Other)
Chlorhexidine group
Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia
干预措施: chlorhexidine antisepsis (Other)
结局指标
主要结局
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
时间窗: After the Puncture and at most 40 minutes
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
时间窗: Before antisepsis
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
时间窗: 2 minutes after antisepsis
The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)
次要结局
未报告次要终点
研究者
Luiz Carlos Tostes
MD
Universidade do Vale do Sapucai