Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening
Primary Purpose
Inflammatory Bowel Disease, Hepatobiliary Disease, Pancreas Disease
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
vancomycin, mupirocin ointment
Sponsored by
About this trial
This is an interventional prevention trial for Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- patients undergoing inflammatory bowel disease (IBD) surgery
- patients undergoing major hepato-biliary-pancreatic surgery
Exclusion Criteria:
- emergency surgery,
- age less than 18 years old
- known allergy to mupirocin or chlorhexidine.
Sites / Locations
- Hyogo College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preoperative MRSA nasal colonization
Arm Description
Interventions in arm of preoperative MRSA nasal colonization consisted of antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA with application of 2% mupirocin ointment twice daily to nares for 5 days
Outcomes
Primary Outcome Measures
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization
Secondary Outcome Measures
The incidence of MRSA infections between intervention and control period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01918813
Brief Title
Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chikara Tashiro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed to evaluate the effect of a targeted preoperative Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk population undergoing gastroenterological surgery. The primary endpoint was to investigate whether the potentially high incidence of MRSA infections in patients with MRSA nasal colonization before surgery can be prevented with a PCR-based strategy. The second endpoint was to investigate the impact of acquisition of MRSA colonization after surgery on the occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited effect in patients with postoperative MRSA acquisition.
Detailed Description
Target screening for nasal carriage of MRSA by polymerase chain reaction (PCR) was performed before or on admission. In order to identify MRSA nasal acquisition while on the ward, all patients who were negative before surgery were re-screened every 7 days until discharge. The inclusion criteria for screening were patients undergoing inflammatory bowel disease surgery on ward A, and those undergoing major hepato-biliary-pancreatic surgery on ward B. Investigators classified enrolled patients into preoperative MRSA nasal carriage, postoperative nasal acquisition in patients who were negative for PCR assay before surgery, and non-nasal MRSA carriage during hospitalization. Development of postoperative infections caused by MRSA was assessed according to the nasal MRSA carriage status. MRSA infections rate was also compared between the 2-years of the intervention period and the previous 2-year control period on each ward.
Control measures in identified MRSA carriers consisted of contact precautions, antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA (application of 2% mupirocin ointment twice daily to nares for 5 days and a bath with 4% chlorhexidine daily for 3-5 days). Although contact precautions were used when caring for MRSA-colonized patients, isolation/cohorting was not routinely practiced.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Hepatobiliary Disease, Pancreas Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
662 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative MRSA nasal colonization
Arm Type
Experimental
Arm Description
Interventions in arm of preoperative MRSA nasal colonization consisted of antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA with application of 2% mupirocin ointment twice daily to nares for 5 days
Intervention Type
Drug
Intervention Name(s)
vancomycin, mupirocin ointment
Other Intervention Name(s)
vancomycin, bactroban ointment
Intervention Description
contact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days
Primary Outcome Measure Information:
Title
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization
Time Frame
Intervention period 2 years
Secondary Outcome Measure Information:
Title
The incidence of MRSA infections between intervention and control period.
Time Frame
Intervention period 2 years, control period 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing inflammatory bowel disease (IBD) surgery
patients undergoing major hepato-biliary-pancreatic surgery
Exclusion Criteria:
emergency surgery,
age less than 18 years old
known allergy to mupirocin or chlorhexidine.
Facility Information:
Facility Name
Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening
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