Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections (MRSA)
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|ClinicalTrials.gov Identifier: NCT01028105|
Recruitment Status : Unknown
Verified December 2009 by Inova Health Care Services.
Recruitment status was: Recruiting
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
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.
|Condition or disease||Intervention/treatment|
|Methicillin-resistant Staphylococcus Aureus Infection||Other: Preoperative MRSA screening|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||975 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||May 2011|
No Intervention: No MRSA screening, Group b
Standard of care
MRSA screening, Group a
MRSA preoperative screening
Other: Preoperative MRSA screening
MRSA preoperative screening and post operative infection rate, 30 days post operative
- 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. [ Time Frame: 30 days ]
- The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis. [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028105
|Contact: Cindy L. Hack, BSNfirstname.lastname@example.org|
|Contact: Cynthia Earley, BSNemail@example.com|
|United States, Virginia|
|Inova Health Care Services||Recruiting|
|Falls Church, Virginia, United States, 22042|
|Contact: Karen G Speroni, BSN, MHSA, PhD 703-868-9278 firstname.lastname@example.org|
|Contact: Lisa Dugan, MSN 703-858-6600 email@example.com|
|Inova Loudoun Hospital||Recruiting|
|Leesburg, Virginia, United States, 20176|
|Contact: Karen G Speroni, BSN, MHSA, PhD 703-868-9278 firstname.lastname@example.org|
|Contact: Lisa Dugan, MSN 703 858 6600 Lisa.Dugan@inova.org|
|Principal Investigator: Cindy L. Hack, BSN|
|Study Director:||Karen G Speroni, BSN, MHSA, PhD||Inova Loudoun Hospital|