Study Stopped
Enrollment did not reach power, therefore study was administratively closed in 2013
Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
MRSA
Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection
1 other identifier
interventional
975
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 7, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJune 8, 2021
June 1, 2021
2.9 years
December 7, 2009
June 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
No MRSA screening, Group b
NO INTERVENTIONStandard of care
MRSA screening, Group a
OTHERMRSA preoperative screening
Interventions
MRSA preoperative screening and post operative infection rate, 30 days post operative
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inova Health Care Serviceslead
- Cardinal Healthcollaborator
Study Sites (2)
Inova Health Care Services
Falls Church, Virginia, 22042, United States
Inova Loudoun Hospital
Leesburg, Virginia, 20176, United States
Study Officials
- STUDY DIRECTOR
Karen G Speroni, BSN, MHSA, PhD
Inova Loudoun Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 7, 2009
First Posted
December 9, 2009
Study Start
February 1, 2008
Primary Completion
January 1, 2011
Study Completion
October 1, 2013
Last Updated
June 8, 2021
Record last verified: 2021-06