跳至主要内容
临床试验/NCT04274517
NCT04274517终止不适用

The Effect of Dilute Chlorhexidine Versus Betadine on Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty: A Prospective Clinical Trial

University of Southern California2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
2
主要终点
Microbial Contamination Rate of Surgical Instruments

研究概览

简要总结

The usage of splash basins in the setting of total knee arthroplasty and total hip arthroplasty presents a risk of contamination and subsequent periprosthetic joint infection. Previous studies have investigated the efficacy of multiple antimicrobial irrigants for preventing periprosthetic joint infection, but the results are varied.

Despite several noteworthy studies on the appropriate usage of different antiseptic solutions in surgical splash basins, the current literature has several limitations. First, there are no head-to-head clinical trials comparing betadine and chlorhexidine gluconate (CHG) usage with relation to periprosthetic joint infection and splash basin contamination rates. Second, the in vitro studies directly cultured splash basin antiseptic solutions rather than culturing surgical instruments.

The objective of this study is to compare the microbial contamination rate of total joint arthroplasty instruments that have been placed in surgical splash basins filled with either sterile water, 3.5% betadine, or 0.05% CHG. The overall purpose of the study is to investigate the efficacy of 0.05% CHG and determine if it is an appropriate solution to use in surgical splash basins for joint replacement surgeries.

A prospective clinical trial will be conducted. Patients treated at the Keck Hospital of USC or USC Verdugo Hills Hospital for primary total hip or total knee arthroplasty will be screened for inclusion in our study. All primary surgeries will be performed according to the preferences of the operating surgeon. No deviations from standard surgical care will be made based on inclusion in this study. However, prior to surgery, patients who elect to participate will be randomized to one of three groups: (1) sterile water, (2) 3.5% betadine, or (3) 0.05% CHG.

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)

盲法说明

Participants will not know which treatment arm they have been randomized to

入排标准

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

入选标准

  • Patients presenting to Keck Hospital of USC or USC Verdugo Hills Hospital for primary total knee arthroplasty or total hip arthroplasty.

排除标准

  • Age < 18 years.
  • History of previous total hip arthroplasty or total knee arthroplasty.
  • History of previous knee or hip joint infection.
  • History of previous allergic reaction to chlorhexidine.
  • Known allergy to iodine or shellfish.

结局指标

主要结局

Microbial Contamination Rate of Surgical Instruments

时间窗: 14 days

Microbial contamination rate of total joint arthroplasty instruments that have been placed in surgical splash basins filled with either sterile water, 3.5% betadine, or 0.05% CHG

次要结局

  • 90-Day Wound Complication(90 days)

研究者

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

Nathanael Heckmann

Assistant Professor of Clinical Orthopaedic Surgery

University of Southern California

研究点 (2)

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