Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- perineural catheter colonization reduction
研究概览
简要总结
Implementation of perineural catheters may lead to infection by catheter colonization. Catheters may be colonized by the bacteria present on the skin. This is most often commensal organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often silent because in the same study only 3% of patients had signs of local inflammation and one psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci (61%) and gram negative bacillus (21.6%).
详细描述
Potential interest of alcoholic Chlorhexidine 2% to reduce the colonization of implanted catheters More recently, it is the antiseptic solution that has been the subject of several studies, including the latest on laying intravascular central catheters, highlights the superiority of alcoholic chlorhexidine 2% compared to povidone iodine alcohol [ 5]. Indeed, it was observed a reduction in the risk of bacterial infection 6 (RR 0 • 15, 95% CI 0 • 05-0 • 41) and of colonization by 5 (RR: 0.18 (95% Cl 0.13-0.24) through the use of alcoholic chlorhexidine with 2% applicator.
Such a study comparing the efficacy of the antiseptic (chlorhexidine vs Povidone-iodine) on the establishment of perineural catheters does not exist what motivated the establishment of our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Patient classified I, II or III by the American Society of Anesthesiology
- •Perineural catheterization use for pain management
- •Patient should have an orthopaedic surgery
排除标准
- •An allergy to povidone iodine
- •An allergy to alcoholic Chlorhexidine 2%
- •Pregnant women
- •Breastfeeding women
研究组 & 干预措施
povidon iodine group
Skin preparation Use of 10 ml of povidone iodine "drug" for disinfection with scrubing "device" Wait at least 30 seondes for drying Perineural catheterization implementation Ultrasonography use
干预措施: povidon iodine (Drug)
2% alcoholic chlorhexidine group
Skin preparation Use of 10 ml of 2% alcoholic Chlorhexidine "drug" for disinfection in place of povidone iodine without scrubing "device" Wait at least 30 secondes for drying Perineural catheterization implementation Ultrasonography use
干预措施: perineural catheterization implementation (Procedure)
2% alcoholic chlorhexidine group
Skin preparation Use of 10 ml of 2% alcoholic Chlorhexidine "drug" for disinfection in place of povidone iodine without scrubing "device" Wait at least 30 secondes for drying Perineural catheterization implementation Ultrasonography use
干预措施: 2% alcoholic chlorhexidine (Drug)
povidon iodine group
Skin preparation Use of 10 ml of povidone iodine "drug" for disinfection with scrubing "device" Wait at least 30 seondes for drying Perineural catheterization implementation Ultrasonography use
干预措施: perineural catheterization implementation (Procedure)
结局指标
主要结局
perineural catheter colonization reduction
时间窗: 24 months
Assuming a frequency of the event without treatment 40%, to highlight a sub treatment relative reduction in frequency of 80% it is necessary to include 92 patients (for a 90% power and a alpha risk of 1%). According to the technique of Brun-Buisson, the catheter will be collected in a neutral tube containing 1 ml of sterile saline. In the laboratory, the tube will be vortexed for one minute and then 10μl of the sample will be seeded in oese calibrated on blood agar. Reading culture will be achieved after 48 hours at 35 ° C aerobically. The catheter will be considered settled if the count found most 1000 UFC / ml. Bacterial identification will be carried out by mass spectrometry and sensitivity by the diffusion method on Muller-Hinton agar. If there is more than one bacterial population, the number of PDUs for each bacterium was determined. In this case, we will consider only the bacterial types\> 1000 UFC / ml
次要结局
- perineural catheter infection(24 months)
研究者
HARKOUK Hakim
clinical assistant chief
Hôpital Raymond Poincaré