Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01028105
Status:
TERMINATED
Last Update Posted:
2021-06-08
First Post:
2009-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 975}}, 'statusModule': {'whyStopped': 'Enrollment did not reach power, therefore study was administratively closed in 2013', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2009-12-07', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preoperative screening', 'MRSA', 'Incidence', 'Postoperative infection', 'Preoperative MRSA Screening Incidence', 'Postoperative MRSA Infection Rate'], 'conditions': ['Methicillin-resistant Staphylococcus Aureus Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nThe central hypothesis to be addressed in this study is whether the MRSA colonization and subsequent post-operative infection are the equivalent in these populations.', 'detailedDescription': 'Design and Methods: Subjects in this study of 975 pre-operative, scheduled surgical patients are in one of the three following groups:\n\n* 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).\n* 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:\n\n * 2a (N=325): MRSA screening; or\n * 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pre-surgical out patient at ILH\n2. Surgical procedure scheduled at least 2 days before surgery\n3. Surgery being done at ILH operating room\n4. Provision of signed ICF\n\nExclusion Criteria:\n\n1. Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent\n2. Inability to communicate in the English language'}, 'identificationModule': {'nctId': 'NCT01028105', 'acronym': 'MRSA', 'briefTitle': 'Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection', 'orgStudyIdInfo': {'id': '08.003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No MRSA screening, Group b', 'description': 'Standard of care'}, {'type': 'OTHER', 'label': 'MRSA screening, Group a', 'description': 'MRSA preoperative screening', 'interventionNames': ['Other: Preoperative MRSA screening']}], 'interventions': [{'name': 'Preoperative MRSA screening', 'type': 'OTHER', 'description': 'MRSA preoperative screening and post operative infection rate, 30 days post operative', 'armGroupLabels': ['MRSA screening, Group a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Health Care Services', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '20176', 'city': 'Leesburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Loudoun Hospital', 'geoPoint': {'lat': 39.11566, 'lon': -77.5636}}], 'overallOfficials': [{'name': 'Karen G Speroni, BSN, MHSA, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inova Loudoun Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardinal Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cynthia Hack', 'investigatorAffiliation': 'Inova Health Care Services'}}}}