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

Sponsor

Inova Health Care Services (Other)

Overall Status

Terminated

CT.gov ID

NCT01028105

Collaborator

Cardinal Health (Industry)

975

Enrollment

Locations

Arms

Duration (Months)

487.5

Patients Per Site

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methicillin-resistant Staphylococcus Aureus Infection	Other: Preoperative MRSA screening	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

975 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No MRSA screening, Group b Standard of care
Other: MRSA screening, Group a MRSA preoperative screening	Other: Preoperative MRSA screening MRSA preoperative screening and post operative infection rate, 30 days post operative

Arm

Intervention/Treatment

No Intervention: No MRSA screening, Group b

Standard of care

Other: MRSA screening, Group a

MRSA preoperative screening

Other: Preoperative MRSA screening

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pre-surgical out patient at ILH
Surgical procedure scheduled at least 2 days before surgery
Surgery being done at ILH operating room
Provision of signed ICF

Exclusion Criteria:

Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent
Inability to communicate in the English language