跳至主要内容
临床试验/NCT04225065
NCT04225065终止4 期

Does Chlorhexidine and/or Betadine Prep Thoroughly Clean the Surgical Sites and Fingernails in Pediatric Arm Surgery Following Trauma?

Mark Seeley2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年6月17日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
入组人数
10
试验地点
2
主要终点
Type and number of organisms found in culture

研究概览

简要总结

There have been numerous studies demonstrating surgical site infections that arise from contamination at time of surgery or by seeding from other sites in the body which arise from organisms normally found on the skin. This has been known to cause complications in spine surgery, shoulder, hip, and knee arthroplasty. While studies have shown that organisms like Cutibacterium persists on the skin despite standard surgical preparation, there have not been studies that examine the organisms found in the fingernail region pre- and post- standard surgical preparations. This study investigates how thorough fingernails are prepped prior to the operation. The results of this study would determine whether providers are adequately cleaning the patient's entire arm, including under the fingernail, prior to surgery. The results may support continuation of the current practice or adding to the standard surgical preparation to ensure adequately sterilization of surgical sites and all exposed areas, which include the fingernails.

详细描述

It is well known that even with surgical skin preparation, there are some microorganisms that remain on the patient's skin. There have been numerous studies demonstrating surgical site infections that arise from contamination at time of surgery or by seeding from other sites in the body which arise from organisms normally found on the skin. This has been known to cause complications in spine surgery, shoulder, hip, and knee arthroplasty. While studies have shown that organisms like Cutibacterium persist on the skin despite standard surgical preparation, there have not been studies that examine the organisms found in the fingernail region pre- and post- standard surgical preparations. It is common practice to not cover the fingernails when patients are undergoing distal upper extremity surgery. Providers tend to consider them prepped when they have the chlorhexidine or betadine preparations applied; however, there is uncertainty regarding how much attention is given to the fingernails. This study investigates how thorough fingernails are prepped prior to the operation. The results of this study would determine whether providers are adequately cleaning the patient's entire arm, including under the fingernail, prior to surgery. The results may support continuation of the current practice or adding to the standard surgical preparation to ensure adequate sterilization of surgical sites and all exposed areas, which include the fingernails.

This is a prospective study design of 20 pediatric patients who are undergoing distal upper extremity surgery. Ten patients will receive a chlorhexidine prep prior to their operation, and the other 10 will receive a betadine prep. Patients will be considered for the study if they are 10 years old or younger and are having either wrist, forearm, or elbow internal fixation surgeries. Three culture specimens will be sent to microbiology: 1) before the surgical skin preparation; 2) after the skin preparation but before the operation; and 3) after the operation. Culture results will be compared pre- and post- surgical prep and between chlorhexidine and betadine preps.

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
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient less than or equal to 10 years of age
  • Undergoing wrist, forearm, or elbow internal fixation surgery

排除标准

  • Patient with known immunodeficiency disorder

结局指标

主要结局

Type and number of organisms found in culture

时间窗: 1 day

Type and number of organisms found in fingernail culture

次要结局

未报告次要终点

研究者

发起方
Mark Seeley
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mark Seeley

Staff Physician

Geisinger Clinic

研究点 (2)

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