Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections (MRSA)
Primary Purpose
Methicillin-resistant Staphylococcus Aureus Infection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative MRSA screening
Sponsored by
About this trial
This is an interventional other trial for Methicillin-resistant Staphylococcus Aureus Infection focused on measuring Preoperative screening, MRSA, Incidence, Postoperative infection, Preoperative MRSA Screening Incidence, Postoperative MRSA Infection Rate
Eligibility Criteria
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
Sites / Locations
- Inova Health Care Services
- Inova Loudoun Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
No MRSA screening, Group b
MRSA screening, Group a
Arm Description
Standard of care
MRSA preoperative screening
Outcomes
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.
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.
Full Information
NCT ID
NCT01028105
First Posted
December 7, 2009
Last Updated
June 3, 2021
Sponsor
Inova Health Care Services
Collaborators
Cardinal Health
1. Study Identification
Unique Protocol Identification Number
NCT01028105
Brief Title
Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
Acronym
MRSA
Official Title
Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment did not reach power, therefore study was administratively closed in 2013
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inova Health Care Services
Collaborators
Cardinal Health
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-resistant Staphylococcus Aureus Infection
Keywords
Preoperative screening, MRSA, Incidence, Postoperative infection, Preoperative MRSA Screening Incidence, Postoperative MRSA Infection Rate
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
975 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No MRSA screening, Group b
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
MRSA screening, Group a
Arm Type
Other
Arm Description
MRSA preoperative screening
Intervention Type
Other
Intervention Name(s)
Preoperative MRSA screening
Intervention Description
MRSA preoperative screening and post operative infection rate, 30 days post operative
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen G Speroni, BSN, MHSA, PhD
Organizational Affiliation
Inova Loudoun Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Inova Health Care Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Inova Loudoun Hospital
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
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