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 | https://doi.org/10.1186/ISRCTN06603006 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/09/2007
- Registration date
- 05/09/2007
- Last edited
- 01/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephan Harbarth
Scientific
Scientific
Geneva University Hospitals
Infection Control Program
Geneva
CH-1211
Switzerland
| Phone | +41 (0)22 372 3357 |
|---|---|
| stephan.harbarth@hcuge.ch |
Study information
| Study design | A prospective, interventional cohort study using a cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A crossover intervention trial to evaluate the impact of rapid on-admission screening in preventing Methicillin Resistant Staphylococcus Aureus (MRSA) infection in surgery |
| Study objectives | 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. |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | MRSA (Methicillin-resistant Staphylococcus aureus) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Number of patients with nosocomial MRSA infection acquired in surgery, expressed as incidence per 1000 patient-days. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2004 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20000 |
| Key inclusion criteria | All patients admitted to the surgical department for greater than 24 hours |
| Key exclusion criteria | Ambulatory surgery |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Geneva University Hospitals
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
The Geneva University Hospitals (Hopitaux Universitaires de Geneve [HUG]) (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Infection Control Unit (Service Prevention Controle Infection [SPCI])
24 rue Micheli-du-Crest
Geneva-14
CH-1211
Switzerland
| Website | https://www.hug.ch/ |
|---|---|
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
Research organisation
Swiss National Science Foundation (Switzerland)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
The Geneva University Hospitals (Hopitaux universitaires de Geneve [HUG]) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 12/03/2008 | Yes | No |
Editorial Notes
01/12/2020: Sponsor website updated.
