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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-10-31

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.

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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.

Conditions

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Methicillin-resistant Staphylococcus Aureus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No MRSA screening, Group b

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

MRSA screening, Group a

MRSA preoperative screening

Group Type OTHER

Preoperative MRSA screening

Intervention Type OTHER

MRSA preoperative screening and post operative infection rate, 30 days post operative

Interventions

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Preoperative MRSA screening

MRSA preoperative screening and post operative infection rate, 30 days post operative

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Pre-surgical out patient at ILH
2. Surgical procedure scheduled at least 2 days before surgery
3. Surgery being done at ILH operating room
4. Provision of signed ICF

Exclusion Criteria

1. Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent
2. Inability to communicate in the English language

Eligible Sex

ALL

Accepts Healthy Volunteers

No