Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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Design and Methods: Subjects in this study of 975 pre-operative, scheduled surgical patients are in one of the three following groups: 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). 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: 2a (N=325): MRSA screening; or 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.

Official Title
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Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection

Conditions
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Methicillin-resistant Staphylococcus Aureus Infection

Intervention / Treatment
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* Other: Preoperative MRSA screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No MRSA screening, Group b<br>Standard of care | |
| Other: MRSA screening, Group a<br>MRSA preoperative screening | Other: Preoperative MRSA screening<br>* MRSA preoperative screening and post operative infection rate, 30 days post operative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative screening, MRSA, Incidence, Postoperative infection, Preoperative MRSA Screening Incidence, Postoperative MRSA Infection Rate