Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 975
- 试验地点
- 4
- 主要终点
- The primary objective of this study is to compare the prevalence of MRSA colonization and its relationship to post-operative infection in patients who are currently pre-operatively MRSA screened per SOP to those who are not.
研究概览
简要总结
The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA carriers. From an evidence-based practice perspective, findings from this study can be considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening requirements for patients with scheduled surgeries.
The central hypothesis to be addressed in this study is whether the MRSA colonization and subsequent post-operative infection are the equivalent in these populations.
详细描述
Design and Methods: Subjects in this study of 975 pre-operative, scheduled surgical patients are in one of the three following groups:
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Group 1 (N=325): Allocation sample of surgical patients required to be MRSA screened per hospital SOP (including patients having a positive MRSA history, orthopedic surgery, undergoing dialysis, or transfer from another hospital, nursing home, skilled nursing facility, or jail).
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Group 2 (N=650): Randomized sample (1:1 ratio) of surgical patients not required to be MRSA screened per hospital SOP, to one of the following two groups:
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2a (N=325): MRSA screening; or
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2b (N=325): No MRSA screening. All subjects were followed for 30 days post-operatively to determine the incidence of post-operative infection. Treatment, diagnostic, and hospitalization data were collected for patients diagnosed with post-operative infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-surgical out patient at ILH
- •Surgical procedure scheduled at least 2 days before surgery
- •Surgery being done at ILH operating room
- •Provision of signed ICF
排除标准
- •Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent
- •Inability to communicate in the English language
结局指标
主要结局
The primary objective of this study is to compare the prevalence of MRSA colonization and its relationship to post-operative infection in patients who are currently pre-operatively MRSA screened per SOP to those who are not.
时间窗: 30 days
次要结局
- The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis.(30 days)
研究者
Cynthia Hack
Principal Investigator
Inova Health Care Services