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

Methicillin-resistant Staphylococcus Aureus Infection Clinical Trial

— MRSA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01028105
• Other study ID #: 08.003
• Status: Terminated
• Phase: N/A
• Start date: February 2008
• Est. completion date: October 2013

Study information

• Verified date: June 2021
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 975
• Est. completion date: October 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Methicillin-resistant Staphylococcus Aureus Infection
• Staphylococcal Infections

Intervention

Other:
• Preoperative MRSA screening
MRSA preoperative screening and post operative infection rate, 30 days post operative

Locations

Country	Name	City	State
United States	Inova Health Care Services	Falls Church	Virginia
United States	Inova Loudoun Hospital	Leesburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	Cardinal Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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