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

NCT ID: NCT01918813

Last Updated: 2013-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 662 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-02-29

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.

Conditions

Inflammatory Bowel Disease; Hepatobiliary Disease; Pancreas Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

vancomycin, mupirocin ointment

Intervention Type: DRUG

contact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days

Interventions

vancomycin, mupirocin ointment

contact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days

Intervention Type: DRUG

Other Intervention Names

vancomycin, bactroban ointment

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chikara Tashiro

OTHER

Sponsor Role: lead

Responsible Party

Chikara Tashiro

Director of hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

Countries

Japan

Other Identifiers

Hyogo college of Medicine 749

Identifier Type: -

Identifier Source: org_study_id