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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Inova Health Care Services.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028105
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cardinal
Information provided by:
Inova Health Care Services
  Purpose

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 Intervention
Methicillin-resistant Staphylococcus Aureus Infection Other: Preoperative MRSA screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

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. [ Time Frame: 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. [ Time Frame: 30 days ]

Estimated Enrollment: 975
Study Start Date: February 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No MRSA screening, Group b
Standard of care
MRSA screening, Group a
MRSA preoperative screening
Other: Preoperative MRSA screening
MRSA preoperative screening and post operative infection rate, 30 days post operative

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028105


Contacts
Contact: Cindy L. Hack, BSN 703-858-8093 cynthia.hack@inova.org
Contact: Cynthia Earley, BSN 703-858-8280 cynthia.earley@inova.org

Locations
United States, Virginia
Inova Health Care Services Recruiting
Falls Church, Virginia, United States, 22042
Contact: Karen G Speroni, BSN, MHSA, PhD    703-868-9278    karen.speroni!@inova.org   
Contact: Lisa Dugan, MSN    703-858-6600    lisa.dugan@inova.org   
Inova Loudoun Hospital Recruiting
Leesburg, Virginia, United States, 20176
Contact: Karen G Speroni, BSN, MHSA, PhD    703-868-9278    karen.speroni@inova.org   
Contact: Lisa Dugan, MSN    703 858 6600    Lisa.Dugan@inova.org   
Principal Investigator: Cindy L. Hack, BSN         
Sponsors and Collaborators
Inova Health Care Services
Cardinal
Investigators
Study Director: Karen G Speroni, BSN, MHSA, PhD Inova Loudoun Hospital
  More Information

Responsible Party: Karen Gabel Speroni, RN, PhD, Director, Nursing Research, Inova Loudoun Hospital
ClinicalTrials.gov Identifier: NCT01028105     History of Changes
Other Study ID Numbers: 08.003
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
Last Verified: December 2009

Keywords provided by Inova Health Care Services:
Preoperative screening
MRSA
Incidence
Postoperative infection
Preoperative MRSA Screening Incidence
Postoperative MRSA Infection Rate

Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents