Can an antibacterial coating on surfaces in an intensive care unit (ICU) prevent methicillin-resistant Staphylococcus aureus (MRSA) acquisition in patients?
ISRCTN | ISRCTN31972004 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN31972004 |
Secondary identifying numbers | N/A |
- Submission date
- 29/10/2018
- Registration date
- 19/11/2018
- Last edited
- 29/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Methicillin-resistant Staphylococcus aureus (MRSA) can cause serious disease that can be difficult to treat because the bacteria cannot be killed by commonly used antibiotics. Patients can acquire MRSA while in hospital and can carry it into the community without showing signs of infection. Surfaces in hospital can be made to contain or can be treated with substances that kill bacteria continuously. This might be an effective way of controlling the spread of MRSA in hospitals. This study aims to investigate whether applying an antibacterial coating to surfaces in an intensice care unit (ICU) could reduce acquisition of MRSA and other disease-causing bacteria in the patients.
Who can participate?
All patients admitted to the medical ICU of Bundang Jesaeng Hospital during the study period were included, except patients aged under 18 years and patients in hospital for less than 72 hours.
What does the study involve?
For the first 5 months of the trial, patients were treated as usual except that the inside of their nostrils were swabbed within 48 hours of ICU admission and at discharge from hospital. A titanium dioxide coating was then applied to surfaces and walls in the ICU that were regularly touched by people. For the next 5 months, patients were again treated as usual except that the inside of their nostrils were swabbed within 48 hours of ICU admission and at discharge from hospital. The swabs were cultured in a laboratory to check for disease-causing bacteria, including MRSA.
What are the possible benefits and risks of participating?:
After the antibacterial coating had been applied, the participants might have a lower risk of acquiring disease-causing bacteria from the hospital environment. Otherwise, they were treated as normal, so there was no additional risk.
Where is the study run from?
The study was performed at Bundang Jesaeng Hospital, a 630-bed secondary care teaching hospital in Gyeonggi-do, South Korea.
When is the study starting and how long is it expected to run for?
January 2016 to December 2017
Who is funding the study?
Bundang Jesaeng Hospital
Who is the main contact?
Su Jin Jeong
Department of Internal Medicine, Yonsei University College of Medicine
50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
(Tel: +82-2-2228-1986; E-mail: JSJ@yuhs.ac.kr; Fax: +82-2-393-6884)
Contact information
Public
Department of Internal Medicine
Yonsei University College of Medicine
50-1 Yonsei-ro
Seodaemun-gu
Seoul
03722
Korea, South
Phone | +82-2-2228-1986 |
---|---|
JSJ@yuhs.ac.kr |
Study information
Study design | Observational cohort study |
---|---|
Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Environmental disinfection with a photocatalyst antimicrobial coating as an adjunctive measure to control transmission of methicillin-resistant Staphylococcus aureus (MRSA) in patients in intensive care units (ICU): a prospective cohort study in a high-incidence setting |
Study hypothesis | We sought to evaluate the usefulness of a photocatalyst to reduce the risk of MRSA transmission, by comparing MRSA acquisition rate and nosocomial infection rate before and after photocatalyst coating. |
Ethics approval(s) | Institutional Review Board of Bundang Jesaeng Hospital Health System Clinical Trials Center, 02/06/2016, Jesaeng Hospital - infection 16-01. Since the study had minimal health risk and the study subjects were anonymized, the Institutional Review Board waived the requirement for written informed consent from the patients. |
Condition | Methicillin-resistant Staphylococcus aureus (MRSA) infection |
Intervention | A titanium dioxide-based photocatalyst was coated on high touch surfaces and walls. 5 months of pre-intervention data were compared with 5 months of post-intervention data. The incidence rates of multidrug-resistant organism acquisition and the rates of hospital-acquired blood stream infection, pneumonia, urinary tract infection, and Clostridium difficile–associated diseases were compared using Cox proportional hazards regression analysis. |
Intervention type | Other |
Primary outcome measure | MRSA acquisition assessed using culture results which were obtained from patients’ nares up to 48 hours after ICU admission and on discharge from ICU. |
Secondary outcome measures | 1. Vancomycin-resistant Enterococcus spp. (VRE) acquisition assessed by reviewing culture results and medical records from admission until discharge from ICU 2. Multidrug-resistant Acinetobacter baumannii (MRAB) acquisition assessed by reviewing culture results and medical records from admission until discharge from ICU 3. Clostridium-difficile–associated disease (CDAD) acquisition assessed by reviewing culture results and medical records from admission until discharge from ICU 4. Hospital-acquired infections (HAI), including bloodstream infection, pneumonia, and urinary tract infection as defined by The Centers for Disease Control and Prevention, assessed by reviewing culture results and medical records from admission until discharge from ICU |
Overall study start date | 01/01/2016 |
Overall study end date | 31/12/2017 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 341 and 280 patients during baseline and intervention periods |
Total final enrolment | 621 |
Participant inclusion criteria | 1. Admitted to the medical intensive care unit during the study period. |
Participant exclusion criteria | 1. Aged <18 years 2. Hospitalized <72 hours |
Recruitment start date | 01/09/2016 |
Recruitment end date | 31/07/2017 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Bundang-gu
Seongnam-si
Gyeonggi-do
Seongnam
463-774
Korea, South
Sponsor information
Hospital/treatment centre
180-2 Seohyeon-ro
Bundang-gu
Seongnam-si
Gyeonggi-do
Seongnam
463-774
Korea, South
Phone | +82-31-779-0000 |
---|---|
webmaster@dmc.or.kr | |
Website | http://www.dmc.or.kr/global/index.do?lang=en |
https://ror.org/03z0bdc81 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | 30/06/2019 |
---|---|
Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | The research findings will be published in high impact research journals and presented at international conferences. |
IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Su Jin Jeong (JSJ@yuhs.ac.kr) immediately after publication of the results. All of the anonymised individual participant data collected during the trial will be available, along with the study protocol and statistical analysis. These data will be available to any applicant for any purpose for an indefinite period. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 03/12/2018 | Yes | No | |
Basic results | 04/01/2018 | 04/01/2019 | No | No |
Additional files
- ISRCTN31972004_BasicResults_04Jan18.pdf
- Uploaded 04/01/2019
Editorial Notes
29/11/2022: Total final enrolment added.
04/01/2019: The basic results of this trial have been uploaded as an additional file.
05/12/2018: Publication reference added.