跳至主要内容
临床试验/NCT04299737
NCT04299737撤回不适用

Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections

Randy Loftus1 个研究点 分布在 1 个国家开始时间: 2020年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Time course in S. aureus transmission decline with the intervention.

研究概览

简要总结

The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

详细描述

Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery.

Patients undergoing planned oncologic gynecological and plastic surgery will be entered as dyads into a worksheet each day that will rank and select the optimal cases. The research assistants consent both patients in the dyad to the study while they are in the Day of Surgery Admissions area. The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac kits are obtained from and analyzed for S. aureus isolates by RDB Bioinformatics. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

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 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
  • •informed, written consent.

排除标准

  • •Patients <18 years of age.
  • •Patients scheduled to undergo procedures outside of the surgical service lines listed above.
  • •Patients not requiring general or regional anesthesia.
  • •Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine.
  • •Patients who have not provided informed, written consent.

结局指标

主要结局

Time course in S. aureus transmission decline with the intervention.

时间窗: Up to 52 weeks

S. aureus transmission events by time.

次要结局

  • Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.(Up to 52 weeks)

研究者

发起方
Randy Loftus
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Randy Loftus

Associate Professor

University of Iowa

研究点 (1)

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