What is the Best Skin Preparation Solution for Labour Epidural Analgesia? A Randomized Prospective Trial Comparing ChloraprepTM, DuraprepTM, and Chlorhexidine 0.5% in 70% Alcohol.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- 25% reduction in skin bacterial colony counts at time of epidural catheter removal
研究概览
简要总结
The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to placing special intravenous lines. There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia. The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective.
详细描述
Bacterial colonization of epidural catheters is known to occur and it has been suggested that catheter contamination occurs more frequently in the obstetric setting. Epidural catheters are usually colonized by the flora present at the skin insertion site and the rate of colonization varies from 5 to 30%. At present, there is a lack of scientific information available in order to make an evidence-based decision about skin disinfection prior to epidural analgesia. The labouring woman appears to have higher risk for infectious complications of epidural analgesia than other surgical patients.
All parturients considering a labour epidural who are admitted to Labour and Delivery at BC Women's Hospital during daytime weekday hours will be given an information sheet on the study by the Assessment room nurse. The Labour and Delivery Room nurses (which includes the Assessment room) are generally the first healthcare providers with whom women discuss labour epidural analgesia once admitted to hospital. All women interested in labour epidural analgesia who are admitted to Labour and Delivery, either via the Assessment room, or from one of the inpatient wards will be provided with the study information. After adequate time has been given for consideration of the study information, one of the researchers who is not directly involved in the patient's care will approach the patient for consent to participate in the study. This will happen prior to the actual request for labour epidural analgesia, therefore avoiding the point of pain at which the woman requires a labour epidural. Written consent will be obtained at that time. Upon request for a labour epidural, the woman will be randomized into one of 3 groups via a computer-generated randomization table (ZRandom). Group C will be ChloraprepTM, Group D: DuraprepTM, and Group S: chlorhexidine 0.5% in 70% alcohol.
Exclusion criteria include: temperature > 38oC orally at time of epidural request, local skin or generalized infection, systemic antibiotics administered prior to epidural request, presence of ruptured membranes > 24 hours, combined spinal-epidural analgesia planned, unable to speak/understand English, allergy to chlorhexidine or iodine, and patient refusal.
The attending anesthesiologist will wear a clean mask, clean his/her hands with either a wet scrub or alcohol-based antiseptic, and don sterile procedure gloves. Patients will be placed in either the left lateral, or sitting position according to anesthesiologist's preference. The skin overlying the lumbar interspaces will then be cleansed with the antiseptic solution, according to the recommended protocol for each solution.
Specific instructions for skin disinfection will be provided in an envelope to the attending anesthesiologist, according to the randomization group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Request labour epidural analgesia. Able to understand English. No antibiotics taken in previous 24 hours. Membranes ruptured less than 24 hours. No current local or systemic infection. No contraindication to labour epidural analgesia
排除标准
- 未提供
结局指标
主要结局
25% reduction in skin bacterial colony counts at time of epidural catheter removal
次要结局
- Skin bacterial colony count immediately following skin antisepsis. Bacterial growth on the epidural catheter tip at time of removal. Number of attempts at epidural insertion. Presence of blood in the epidural catheter at time of insertion.
