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临床试验/NCT00353613
NCT00353613已完成不适用

Prevention of Surgical Site Infections

The University of Texas Health Science Center, Houston4 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
4
主要终点
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections

研究概览

简要总结

The primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections.

详细描述

Background: Surgical site infections (SSIs) cause significant and largely preventable morbidity, mortality, and resource use due to failure to comply with evidence-based guidelines. Quality improvement programs report increased compliance with these guidelines, but are subject to a variety of biases.

Hypothesis

The primary hypothesis is that a targeted intervention program will increase the proportion of patients in a county hospital who receive recommended interventions to prevent SSIs, when assessed in the most rigorous feasible clinical trial. The specific aims of the trial are to establish practical surveillance measures to determine the percentage of patients whose care complies with 5 major guidelines to prevent SSIs; to use chart review, direct observation, attitude surveys, and focus groups to identify, quantify, and address latent and active errors linked to non-compliance, and to develop, implement, and assess the effectiveness of an intervention program to increase guideline compliance.

Study Design: An innovative trial design will be performed with 3 staggered phases in the two major county hospitals in Houston, TX. This design allows for adjustment for temporal trends and hospital differences in assessing the intervention program in a large, high-risk, disadvantaged urban population. Based on a compliance goal of 95%, this design has adequate power to detect even a small absolute increase ( >= 5%) above baseline in the percentage of patients receiving all 5 recommended preventive measures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas

排除标准

  • 未提供

结局指标

主要结局

Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections

时间窗: 1 year

次要结局

  • Surgical site infections(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lillian Kao

Associate Professor - Surgery

The University of Texas Health Science Center, Houston

研究点 (4)

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