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临床试验/NCT00896402
NCT00896402撤回不适用

Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty

Northwell Health2 个研究点 分布在 1 个国家开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application

研究概览

简要总结

Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common.

The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.

详细描述

After antisepsis four different cultures will be analyzed:

  1. The femoral nerve catheter will be removed after 48 hours and a culture of the distal tip of the femoral nerve catheter will be performed between the 2 arms.
  2. immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.
  3. immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.
  4. just prior to removal of the femoral nerve catheter, a culture of the skin/catheter interface will be performed between the 2 arms.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing primary total knee arthroplasty.

排除标准

  • Hypersensitivity/allergy to antiseptics,
  • Recent opioid/alcohol abuse,
  • Presence of contraindications to regional anesthesia,
  • Coagulation disorder,
  • Diabetic/femoral neuropathy,
  • Prior surgery to inguinal area,
  • Patient refusal.

研究组 & 干预措施

Chlorhexidine

Active Comparator

skin antisepsis with chlorhexidine

干预措施: Skin antisepsis with chlorhexidine (Drug)

Povidone-iodine

Active Comparator

skin antisepsis with povidone-iodine

干预措施: povidone-iodine (Drug)

结局指标

主要结局

Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application

时间窗: July 2013

次要结局

  • Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface(July 2013)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Marino M.D.

Chief of Anesthesiology

Northwell Health

研究点 (2)

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