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

Information source: Inova Health Care Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methicillin-resistant Staphylococcus Aureus Infection

Intervention: Preoperative MRSA screening (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Inova Health Care Services

Official(s) and/or principal investigator(s):
Karen G Speroni, BSN, MHSA, PhD, Study Director, Affiliation: Inova Loudoun Hospital

Overall contact:
Cindy L. Hack, BSN, Phone: 703-858-8093, Email: cynthia.hack@inova.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: 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.

Secondary outcome: The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis.

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Cindy L. Hack, BSN, Phone: 703-858-8093, Email: cynthia.hack@inova.org

Inova Health Care Services, Falls Church, Virginia 22042, United States; Recruiting
Karen G Speroni, BSN, MHSA, PhD, Phone: 703-868-9278, Email: karen.speroni!@inova.org
Lisa Dugan, MSN, Phone: 703-858-6600, Email: lisa.dugan@inova.org

Inova Loudoun Hospital, Leesburg, Virginia 20176, United States; Recruiting
Karen G Speroni, BSN, MHSA, PhD, Phone: 703-868-9278, Email: karen.speroni@inova.org
Lisa Dugan, MSN, Phone: 703 858 6600, Email: Lisa.Dugan@inova.org
Cindy L. Hack, BSN, Principal Investigator

Additional Information

Starting date: February 2008
Last updated: December 8, 2009

Page last updated: August 23, 2015

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