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临床试验/NCT03926208
NCT03926208已完成不适用

Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2019年5月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
242
试验地点
2
主要终点
Bacterial Culture Growth

研究概览

简要总结

Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.

详细描述

Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. This is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. In particular, the nail folds of the toes are known to harbor large amounts of bacteria.

A systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. Articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. But even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases.

The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold.

It is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak & scrub will be less likely to have culture positive swabs of the hallux nail fold.

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
None

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

  • ≥ 18 years of age
  • Patient requires a foot or ankle operative procedure
  • Patient provides informed consent

排除标准

  • Patient refuses
  • Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent

结局指标

主要结局

Bacterial Culture Growth

时间窗: 1 day

Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.

次要结局

未报告次要终点

研究者

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

Kamran S Hamid, MD

Principle Investigator, M.D. MPH

Rush University Medical Center

研究点 (2)

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