Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease; Pancreas Disease; Hepatobiliary Disease
• Intervention / Treatment: Drug: vancomycin, mupirocin ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 662
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Hyogo College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Preoperative MRSA nasal colonization; 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	Drug: vancomycin, mupirocin ointment; contact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days; Other Names: vancomycin, bactroban ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization	Intervention period 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of MRSA infections between intervention and control period.	Intervention period 2 years, control period 2 years

Collaborators and Investigators

• Sponsor: Chikara Tashiro

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (ESTIMATE): August 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Liver Diseases; Inflammatory Bowel Diseases; Digestive System Diseases; Pancreatic Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Mupirocin
• Other Study ID Numbers: Hyogo college of Medicine 749