Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Inova Health Care Services.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cardinal
Information provided by:
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01028105
First received: December 7, 2009
Last updated: December 8, 2009
Last verified: December 2009
History of Changes
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 7, 2009
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board

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:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013