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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01028105
Acronym
MRSA
Enrollment
975
Registered
2009-12-09
Start date
2008-02-29
Completion date
2013-10-31
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-resistant Staphylococcus Aureus Infection

Keywords

Preoperative screening, MRSA, Incidence, Postoperative infection, Preoperative MRSA Screening Incidence, Postoperative MRSA Infection Rate

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.

Interventions

OTHERPreoperative MRSA screening

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

Sponsors

Cardinal Health
CollaboratorINDUSTRY
Inova Health Care Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026