Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Bacteria detection
研究概览
简要总结
The aim of this study was to investigate the influence of alcoholic skin disin-fection before PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous part of the PNC or on the tip. Furthermore, the correlation of bacterial colonization with PNC-associated local inflammation or infection was evaluated.
详细描述
Two hundred orthopedic patients planned to receive a PNC are prospectively randomized to group PNC-removal with alcoholic skin disinfection or group PNC-removal without skin disinfection.
After standardized PNC-placement under sterile conditions, patients receive a perioperative antibiotic prophylaxis and clinical signs of local inflammation or infection are periodically recorded: The PNC were observed twice daily for clinical signs of local inflammation and local infection. Patients were also evaluated for clinical signs of systemic infection. The adhesive dressing was changed only if it became dislodged or if blood or secretions made visualization of the puncture site impossible. For the dressing change, the anaesthesiologist wore a facemask, a cap and sterile gloves.
Postoperatively, 6 hours after the initial bolus, a local anaesthetic infusion line was connected to the micro filter of the PNC. All patients received patient-controlled perineural analgesia (basal rate 5 ml/h, bolus 4 ml, lock-out time 20 min) with ropivacaine 0.3% for 24 hours, and then reduced to ropivacaine 0.2%.
PNC were removed under sterile conditions after 72h or earlier in the case of signs of infection: Removal of the PNC was performed on the surgical ward by an anaesthesiologist according to a standardized procedure: Wearing a facemask and a cap, the adhesive skin dressing was removed. In the "WITH-group", the skin was now disinfected with an aerosolized alcoholic solution (propanol-biphenol). Procedure continued after three minutes, when the skin was dry with the anaesthesiologist wearing sterile gloves and using sterile tweezers.
The distal part of the PNC (directed to the tip of the PNC) was withdrawn for 1 cm at the insertion site and then cut distally from the tweezers with a sterile pair of scissors. The distal part of the PNC was then totally withdrawn with the sterile tweezers, and with the sterile pair of scissors cut in two parts: the tip (defined as the most distal 2 cm) and the subcutaneous part, which were placed in separate dry sterile containers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent, surgery with perineural catheters
排除标准
- •diabetes mellitus, medication with immunosuppressant drugs or any other immune-compromising illness
结局指标
主要结局
Bacteria detection
时间窗: After removal of PNC 72h after its insertion
The reduction of the PNC-colonization rate depending on the removal technique (with or without previous skin disinfection)
次要结局
- sensitivity: to measure the proportion of positives that are correctly identified as such (the percentage of colonized catheters which clinically show an infection). Sensitivity = all clincally positive / all catheters (no unit)(After removal of PNC 72h after its insertion until one week after PNC-removal)
- Specifity: measures the proportion of negatives that are correctly identified as such (the percentage of not colonized catheters which clinically do not show an infection). Specifity = all clinically negative / all catheters (no unit)(After removal of PNC 72h after its insertion until one week after PNC-removal)
- negative predictive value: all testing negative and no clinical signs of local infection / all testing negative (no unit)(After removal of PNC 72h after its insertion until one week after PNC-removal)
- Positive predictive value: all testing positive and with clinically infection / all testing positive (no unit)(After removal of PNC 72h after its insertion until one week after PNC-removal)
