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临床试验/NCT02434510
NCT02434510已完成不适用

Bacterial Contamination of Operative Splash Basins: Can it be Prevented?

University of Utah1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Bacterial Contamination

研究概览

简要总结

The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine gluconate to the splash basin in reducing bacterial growth from splash basins at the end of a total joint replacement procedure.

Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at the end of elective total joint arthroplasty cases.

Null Hypothesis: There will be no difference in bacterial growth from the splash basin at the end of the case despite the addition of an antimicrobial solution.

详细描述

Total joint arthroplasty of the hip and knee is a procedure growing substantially in number in the United States. Projections approach 2 million combined total hip and total knee arthroplasty procedures by the year 2021[1, 2]. With the incidence of post-arthroplasty infection ranging from 1-2% of primaries and 3-5% of revisions, the number of cases of periprosthetic infection will be significant[1, 3-7]. The associated economic burden is projected to exceed $1.62 billion[2]. With these numbers in mind it is our responsibility in the orthopaedic community to do what we can to reduce the social and economic impact that this devastating complication creates.

While all surgical procedures carry the risk of bacterial contamination, those that implant prosthetic material are particularly high risk for future problems due to the development of biofilms and difficulty eradicating such infections. The most common time of inoculation of the implant is at the time of surgery. Whyte et al.[8] showed that the source of infection was the operating room personnel in 98% of cases while only 2% of the time it was the patient's own skin. The transfer of contaminants occurred via direct transfer through the hands or instruments 70% of the time. Knobben et al.[9] reported transfer of bacteria between biomaterial surfaces at a rate of 17%-71% demonstrating the ability of bacteria to spread to all types of materials in the operative field. The direct contact of these surfaces with the patient or prosthetic implant makes early contamination during surgery a likely cause of periprosthetic infection. Maathuis et al.[10] suggested that at least 30% of patients leave the operating suite with bacterial contamination.

The splash basin has been used for many years in the operating room as a place to wash instruments and clean them of debris for potential re-use during the surgical case. This often places multiple instruments within the bath of washings or in direct contact with previously used tools. Several studies have shown evidence of bacterial contamination of these basins[11-14]. Rates of 2.17% to 74% of contamination of the splash basin have been reported. In a study by Anto et al.[11] an average of 45.7 instruments were placed in the splash basin per case. The opportunity for bacteria to be transferred to the surgical wound upon re-use of an instrument from the basin is therefore concerning.

Given that the splash basin is a potential source of surgical wound contamination we have sought to eliminate the bacterial colonization of this source through the addition of an antimicrobial solution to the normal sterile water bath. To compare potential interventions, a prospective study comparing a 0.05% chlorhexidine gluconate (CHG) antimicrobial solution to the current standard of sterile water as a control is proposed. This concentration of CHG followed by a saline rinse has been shown to decrease the risk of infection during wound irrigation without increasing the risk of adverse effects[15, 16].

Given our expertise in the area of total joint arthroplasty and experience with treating periprosthetic infections as well as familiarity with various antimicrobial solutions we feel well qualified to perform this study. The results of this study could improve patient outcomes by potentially eliminating a source of infection in the operating room.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Splash Basins will be selected from primary total joint arthroplasty cases and then randomized to a solution of either sterile water or sterile water with 0.05% CHG.
  • Other than being scheduled for a primary total joint arthroplasty, the participant information will not be reviewed for selection of the splash basin, but will be collected for comparison of patient characteristics and potentially for future reference to compare infection rates in patients associated with this study.

排除标准

  • Splash basin used in a revision total joint procedure
  • Splash basin used in cases where the patient has a history of known periprosthetic joint infection
  • Splash basin used in cases where the patient has a known allergy to chlorhexidine gluconate

结局指标

主要结局

Bacterial Contamination

时间窗: up to 1-3 days

After 1-3+ days, agar plates (cultured with splash basin solution) will be pulled from incubation and examined for growth. Basins with any growth of aerobic organisms will be considered as a positive finding.

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

Jeremy Gililland

M.D.

University of Utah

研究点 (1)

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