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

NCT01918813 | Completed

• 1 other identifier: Hyogo college of Medicine 749
• Study Type: interventional
• Target: 662
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Hepatobiliary Disease; Pancreas Disease

Outcome Measures

Primary Outcomes (1)

• The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization

  Intervention period 2 years

Secondary Outcomes (1)

• The incidence of MRSA infections between intervention and control period.

  Intervention period 2 years, control period 2 years

Study Arms (1)

Preoperative MRSA nasal colonization

EXPERIMENTAL

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

Interventions

vancomycin, mupirocin ointment DRUG

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

Also known as: vancomycin, bactroban ointment

Preoperative MRSA nasal colonization

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing inflammatory bowel disease (IBD) surgery
• patients undergoing major hepato-biliary-pancreatic surgery

You may not qualify if:

• emergency surgery,
• age less than 18 years old
• known allergy to mupirocin or chlorhexidine.

Sponsors & Collaborators

• Chikara Tashiro: lead

Study Sites (1)

Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Digestive System Diseases; Pancreatic Diseases

Interventions

Vancomycin; Mupirocin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of hospital

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 8, 2013
• Study Start: November 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 8, 2013

Record last verified: 2013-08

Locations

JP (1)