跳至主要内容
临床试验/NCT01175044
NCT01175044已完成4 期

Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
505
试验地点
2
主要终点
Infection Rate

研究概览

简要总结

The purpose of this study is to examine the efficacy of a dilute betadine solution in reducing infectious complications in revision total knee arthroplasty. The investigators will enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients will be randomized into two groups. The treatment group will receive a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and the control group will receive the 2000ml sterile saline lavage alone.

详细描述

Infections in total knee arthroplasty are still a major source of morbidity and mortality in Orthopaedics. They often necessitate long term antibiotics, reoperation, and can lead to further complications such as sepsis or even death. Infection prevention remains one of the primary goals of an orthopedic surgeon. While most sources report the infection rate for primary total knee arthroplasty to be less than 1%, the reported rate for infection in revision total knee arthroplasties has been reported to be as high as 5.6%. Despite steps taken towards infection prevention such as proper administration of preoperative antibiotics, strict adherence to sterile methods, and meticulous sterile preparation of the surgical site; infection remains higher in the total knee revision arthroplasty patient population when compared to primary total knee arthroplasty. A dilute betadine lavage (0.35% to 1% povidone iodine) prior to surgical closure has been shown in general surgical procedures as well as orthopaedic spine surgeries to reduce the infection rate in their patients, but this has not been examined in total joint arthroplasty.

The study will enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients will be randomized into two groups. The treatment group will receive a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and the control group will receive the 2000ml sterile saline lavage alone. All other treatment will be standard of care.

Subjects will then be followed for one year post surgery for infection, as defined by Appendix 1, at intervals of 2 weeks, 6 weeks, 3 months, and one year from the date of surgery. During these visits patients will receive standard post operative care which includes infection screening. If an infection is clinically suspected with symptoms such as warmth and erythema over the joint, reduced mobility of the joint, and increasing pain at the joint, then infection data will be collected which will consist of a Erythrocyte Sedimentation Rate, C-Reactive Protein levels and a synovial fluid sample will be taken for white blood cell count and bacterial culture.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Scheduled to undergo revision total knee arthroplasty

排除标准

  • •Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
  • •Allergy to povidone iodine.
  • •Any condition requiring antibiotics 14 days prior to arriving for surgery.
  • •Patients with chronic immunosuppression (such as HIV/AIDS).
  • •Unable to adhere to follow up schedule and treatment.
  • •Patients scheduled to undergo revision total knee arthroplasty for infectious reasons.

研究组 & 干预措施

Saline Lavage

Placebo Comparator

2000 ml sterile saline lavage alone

干预措施: Saline Lavage (Procedure)

Betadine Lavage

Active Comparator

dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation

干预措施: Betadine Lavage (Procedure)

结局指标

主要结局

Infection Rate

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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