跳至主要内容
临床试验/NCT03638947
NCT03638947终止不适用

Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)

Randy Loftus2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2018年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
236
试验地点
2
主要终点
Quantitate the Reduction of S. Aureus Tranmission

研究概览

简要总结

The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery.

详细描述

The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery. The investigators will combine several approaches in a "bundle" of activities to achieve this goal. The bundle will include removal of bacterial pathogens from patient skin sites before surgery, from provider hands before, during, and after surgery, from environmental surfaces before and after terminal cleaning, and from the injection ports of patient intravenous catheters. The investigators will use a new surveillance system to evaluate how well the bundle, and each component of the bundle, is working. Surveillance will identify S. aureus transmission events, and movement of S. aureus between reservoirs before, during, and after surgery (perioperative). Surveillance will map transmission events to identify actionable steps to improve the bundle. An infection control perioperative team will act on the surveillance reports to proactively address the action items, and to measure the effect of their efforts for the treatment group. The investigators will compare perioperative S. aureus transmission events for patients receiving the bundle to perioperative S. aureus transmission events for patients receiving usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

After the patient has signed consent, they will receive a pre-surgical kit that will include swabs to be used in the nares, arm pit and groin area (standard of care). In a 1:1 randomization scheme, one half of the patients will receive povidone-iodine swab in addition to the kit (treatment).

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

  • At least 18 years of age
  • Undergoing surgery (orthopedic total joint, orthopedic spine, Gynecological/Oncology, thoracic, general, hernia, colorectal, open vascular, plastic surgery and open urological)
  • Ability to sign informed consent
  • Require general or regional anesthesia

排除标准

  • Less than 18 years of age
  • Inability to sign informed consent
  • Procedures not included above
  • Not requiring general or regional anesthesia

结局指标

主要结局

Quantitate the Reduction of S. Aureus Tranmission

时间窗: Up to 180 days following surgery

Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.

次要结局

  • Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits(Preoperative)

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

Clinical Associate Professor

University of Iowa

研究点 (2)

Loading locations...

相似试验