Clinical trial NCT01028105: Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
Official title: Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Methicillin-resistant Staphylococcus Aureus Infection
Keywords: Preoperative screening
MRSA
Incidence
Postoperative infection
Preoperative MRSA Screening Incidence
Postoperative MRSA Infection Rate
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Cardinal Health
First posted: 2009-12-09
Enrollment: 975
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis.
timeFrame: 30 days
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
city: Leesburg
country: United States
facility: Inova Loudoun Hospital
state: Virginia
Study officials:
affiliation: Inova Loudoun Hospital
name: Karen G Speroni, BSN, MHSA, PhD
role: STUDY_DIRECTOR
References: