Welcome
Support Centre
25 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A crossover intervention trial to evaluate the impact of rapid on-admission screening in preventing Methicillin Resistant Staphylococcus Aureus (MRSA) infection in surgery
ISRCTN ISRCTN06603006
DOI 10.1186/ISRCTN06603006
ClinicalTrials.gov identifier
EudraCT number
Public title A crossover intervention trial to evaluate the impact of rapid on-admission screening in preventing Methicillin Resistant Staphylococcus Aureus (MRSA) infection in surgery
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis To determine the effect of an early MRSA detection strategy on nosocomial MRSA infections in a cohort of surgical patients at a large teaching hospital.
Lay summary
Ethics approval Ethics approval received from the local Institutional Review Board (Commission centrale d'éthique de la recherche aux HUG) on the 18th August 2004 (ref: JSL/cg, 126-2004).
Study design A prospective, interventional cohort study using a cross-over design
Countries of recruitment Switzerland
Disease/condition/study domain MRSA (Methicillin-resistant Staphylococcus aureus)
Participants - inclusion criteria All patients admitted to the surgical department for greater than 24 hours
Participants - exclusion criteria Ambulatory surgery
Anticipated start date 01/07/2004
Anticipated end date 30/09/2006
Status of trial Completed
Patient information material
Target number of participants 20000
Interventions We carried out a prospective, interventional cohort study using a cross-over design to compare the effect of two different MRSA control strategies (rapid MRSA screening plus standard control versus standard infection control only) on the acquisition of nosocomial MRSA infection.

The study was conducted in the surgical department of the University of Geneva Hospitals (365 beds and 13,280 admissions in 2004). Twelve wards (including abdominal surgery, orthopedics, urology, neurosurgery, cardiovascular surgery, thoracic surgery, plastic surgery and solid organ transplant) were enrolled in the study. The study population included all adult patients admitted to the surgical department for greater than 24 hours. Patients admitted for ambulatory surgery were excluded as they were considered to be at low risk of MRSA infection.

Each ward was assigned to 1 of the 2 study groups and enrolled according to a pre-specified agenda encompassing 4 study phases. Phase I (July to September 2004) comprised a baseline surveillance period without MRSA on-admission screening. Phase II (October 2004 to June 2005) consisted of a 9-month intervention period with application of the rapid screening tool in neurosurgery, orthopedics, plastic surgery, cardiovascular and thoracic surgery, whereas the remaining wards served as control units. Follow-up of MRSA infections was continued in all wards throughout the next 2 months (phase III, washout period). In September 2005, the wards were switched for a further 9 months (crossover phase) to balance the effect of possible ward-related confounding variables. In phase IV (September 2005 to May 2006), rapid MRSA screening was applied to patients in urology, transplant and abdominal surgery. Follow-up of those patients who were operated before May 31, 2006 was terminated by September 2006.

The main study intervention consisted of the introduction of a molecular technique to enable early detection of MRSA carriage by rapid screening of admitted patients (including both elective and emergency admissions) in the intervention units. Standard infection control measures applied to MRSA patients in all units comprised the following elements: 1. Contact isolation of identified MRSA carriers in flagged side or single rooms, whenever available, with dedicated material (gowns, gloves, masks)
2. Topical decolonisation (nasal mupirocin ointment and chlorhexidine body washing) of known MRSA carriers for 5 days
3. Guidelines to adapt perioperative prophylaxis of MRSA carriers
4. A computerised MRSA alert system

No preemptive isolation was installed for patients without history of MRSA carriage. During the study, no antibiotic stewardship program was implemented.
Primary outcome measure(s) Number of patients with nosocomial MRSA infection acquired in surgery, expressed as incidence per 1000 patient-days.
Secondary outcome measure(s) 1. Nosocomial MRSA acquisition rate (expressed as the rate of new MRSA cases detected by any type of clinical isolate in previously MRSA-free patients per 1000 patient-days)
2. The rate of surgical site infections (per 100 procedures) and other site-specific infections caused by MRSA
Sources of funding 1. Swiss National Science Foundation (Switzerland)
2. The Geneva University Hospitals (Hopitaux universitaires de Geneve [HUG]) (Switzerland)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18334690
Contact name Dr  Stephan   Harbarth
  Address Geneva University Hospitals
Infection Control Program
  City/town Geneva
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 372 3357
  Fax +41 (0)22 372 3987
  Email stephan.harbarth@hcuge.ch
Sponsor The Geneva University Hospitals (Hopitaux Universitaires de Geneve [HUG]) (Switzerland)
  Address Infection Control Unit (Service Prevention Controle Infection [SPCI])
24 rue Micheli-du-Crest
  City/town Geneva-14
  Zip/Postcode CH-1211
  Country Switzerland
  Sponsor website: http://www.hug-ge.ch/
Date applied 05/09/2007
Last edited 13/03/2008
Date ISRCTN assigned 05/09/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.