Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
- Conditions
- Methicillin-resistant Staphylococcus Aureus Infection
- Interventions
- Other: Preoperative MRSA screening
- Registration Number
- NCT01028105
- Lead Sponsor
- Inova Health Care Services
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 975
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRSA screening, Group a Preoperative MRSA screening MRSA preoperative screening
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Inova Health Care Services
🇺🇸Falls Church, Virginia, United States
Inova Loudoun Hospital
🇺🇸Leesburg, Virginia, United States