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临床试验/NCT01174212
NCT01174212已完成4 期

Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Rush University Medical Center4 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
65
试验地点
4
主要终点
Changes in cultures obtained preoperatively and intraoperatively

研究概览

简要总结

Subjects will be consented and then determined randomly whether they will receive antibiotics prior to their surgery or during their surgery. Each patient will have cultures taken before and during their surgery from the infected hip or knee. Results will be compared after completion of the study.

详细描述

It is unknown whether giving pre-operative antibiotics affects the results of intraoperative bacterial cultures. This is an important question as antibiotics are often not given prior to surgery out of concern that accurate culture results will not be obtained. It is important to obtain accurate cultures so that targeted antibiotic therapy can be used. However, delaying the administration of antibiotics also delays the onset of treatment. Currently, the optimal course of action is unknown. The purpose of this study is to resolve this issue and determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection.

This is a prospective randomized clinical study to determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection. Pre-operatively, patients will have their affected joint aspirated and this fluid will be sent for cultures. Patients are then randomized to receive prophylactic antibiotics (Vancomycin and Ancef) within one hour prior to surgery or to have pre-operative antibiotics withheld. Every patient then has their affected joint cultured intra-operatively. All samples will be evaluated for the presence of aerobic bacteria, anaerobic bacteria, mycobacteria, and fungus. Pre-operative and post-operative cultures in both study populations are compared to determine the effects of pre-operative antibiotics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • prior arthroplasty surgery of the hip or knee
  • presentation to clinic with infected joint
  • scheduled for revision surgery

排除标准

  • patients who have received antibiotics for any reason within 4 weeks of their pre-operative culture
  • infected native joints
  • septic patients
  • refusal of participation

结局指标

主要结局

Changes in cultures obtained preoperatively and intraoperatively

时间窗: 1 year

Patients suspected of having an infected total hip or knee replacement in the post-operative period will be evaluated clinically. Preoperative and intraoperative revision cultures will be compared.

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

Craig J Delle Valle

MD

Rush University Medical Center

研究点 (4)

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