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

Inova Health Care Services

Status: Terminated

Conditions: Methicillin-resistant Staphylococcus Aureus Infection

Treatments: Other: Preoperative MRSA screening

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01028105

08.003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 975 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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975 participants in 2 patient groups

No MRSA screening, Group b

No Intervention group

Description:

Standard of care

MRSA screening, Group a

Other group

Description:

MRSA preoperative screening

Treatment:

Other: Preoperative MRSA screening