A Multi-level Antimicrobial Surface Coating for a Healthier Environment

January 3, 2019 updated by: King Lun Yeung, Hong Kong University of Science and Technology
This project aimed to study the use of the multi-level antimicrobial coating in a working hospital environment. Patient privacy curtains from a public sector hospital were coated and installed in rehabilitation ward in comparison of normally washed curtains in the same setting and compared the mean reduction on both control and treatment end to assess the effectiveness of coating against hospital acquired infections including multidrug resistant organisms (MDROs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. A multi-level antimicrobial coating was produced in the Hong Kong University of Science and Technology (HKUST) laboratory using the newly developed staged flow micromixing to prepare contact-killing and anti-adhesion coating made of US-FDA approved polymeric materials. The process was optimized to scale-up the production to 5 liters per hour. 300 liters of the multi-level antimicrobial coating was prepared for the study for a total of 24 weeks as three liters of the coating was needed for one patient privacy curtain.
  2. The study was conducted in the rehabilitation ward of the Kowloon Hospital including both male and female cubicles. It was carried out in three stages with each stage consisting of survey and a four weeks' observation period, separated by three weeks' washout period. In the rehabilitation ward of Kowloon Hospital, a set of male and female cubicle was recruited for the study after getting maximum number of bacterial contamination on patient privacy curtains in pilot study of 8 weeks. Each cubicle had 12 curtains besides admitted patients where all the samples are collected.

  3. Environmental sampling was carried out using sponge swab on the surfaces of the patient privacy curtains. The total bacteria count and quantitative isolation of MRSA was done using established protocols. The total bacteria count provides a quantitative measure of surface cleanliness, while the methicillin-resistant Staphylococcus aureus (MRSA) count was indicative of the risk of contact transmission from contaminated surfaces. 2-4 weeks survey provided control data on the cleanliness of patients privacy curtains in terms of total bacteria and MRSA counts.

    During the study period, the Kowloon Hospital/Queen Elizabeth Hospital infection control team monitored MDROs regularly as part of their routine operation. The procedure and schedule was followed strictly the infection control protocol. All infection control measures implemented after isolation of MDROs were followed according to the hospital's usual practice as advised by the infection control team. In the study, the identification of the organisms in patients more than 48 hours after admission without prior isolation of the organisms in clinical or screening specimens was defined as nosocomial.

  4. The investigators demonstrated a cross-over intervention study. In the first stage of study, half of the patient privacy curtains were considered as treatment (antimicrobial coated) and the other half of the curtains as control in the same setting in a cubicle. As the study was double blind, so coding was done to identify the treatment as control curtains.
  5. Sample were taken from eight highly touched areas of 50x50 cm² on weekly bases for three consecutive weeks on 7th day of first installation. On each period/phase 480, 576 and 786 samples were collected accordingly using the developed sample protocol. In total, the investigators collected 1824 samples from 76 patient privacy curtains in which 912 (50%) were control curtain and 912 (50%) are antimicrobial coated curtains.
  6. Healthcare workers from the participating wards were assessed for their acceptance of the multilevel antimicrobial disinfectant coating by way of a questionnaire. Additional reformulation may be necessary to increase the acceptability of the coating technology to the healthcare workers.
  7. For the bacteria count, duplicate plates of tryptic soy agar (TSA) for total bacteria count and Chromagar MRSA (selective agar for MRSA detection) were used for enumeration. CFU/m² is calculated after 48 hours incubation at 37°C. Data was analyzed using Statistical Package for the Social Sciences (SPSS) V.25 to assess the effectiveness of the coating in reducing the contamination level of the surface. The total bacteria count on the patient privacy curtains was compared between the control and treatment group using Mann-Whitney test and T-test. ANOVA analysis allowed the comparison of different periods of study of phase wise as well as week wise. The significance of the statistical test is defined to have a P value <0.05.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong, 0000
        • Kowloon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A convalescence ward with reasonable amount of nursing activities
  • No recent history of outbreaks of communicable diseases in the wards

Exclusion Criteria:

  • Wards with little nursing activities including infirmary wards
  • Wards with frequent outbreaks which lead to excessive curtain changes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Regular Patient privacy curtain
Control arm is a regular patient privacy curtain, washed and dried in hospital laundry using commercially available sodium hypochlorite and hydrogen peroxide.
Combination product: Regular Patient privacy curtain
Laundered curtains, used in the hospital, coming from the hospital inventory.
EXPERIMENTAL: Antimicrobial Coated Curtains
Treatment arm is an antimicrobial coated curtains, which is obtained by dipping the hospital laundered curtains into the antimicrobial coating. The curtains are then dried and provided to the nursing/supporting staff.
Combination product: Regular Patient privacy curtain
Laundered curtains, used in the hospital, coming from the hospital inventory.
Combination product: Antimicrobial Coated curtains
Antimicrobial coating consist of active polymers that are approved by USFDA and USEPA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total bacteria count and MRSA in control vs treatment patient privacy curtains
Time Frame: 12 weeks
To quantify the effectiveness of antimicrobial coating, percentage change (both in log and linear scale) in mean bacterial count (CFU/m2 units) in control versus treatment curtains is used. The data was collected in 3 phases of 4 weeks each, so the time frame used is representative of the complete observation period.
12 weeks
Durability of antimicrobial coating in affecting bacterial load amongst treated patient privacy curtains
Time Frame: 12 weeks
Change in bacterial load amongst treatment curtains is observed as a function of time during each phase of the data collection period (for 4 weeks). In total, data was collected in 3 phases of 4 weeks each, so the total observation period is 12 weeks and timeframe of each frame is 4 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement/disagreement of hospital staff regarding technology acceptance and adaptation
Time Frame: 4 weeks
A survey was conducted using a self-structured questionnaire to get feedback from the hospital staff regarding their acceptance of the technology. The questionnaire contained questions regarding the physical (smell, appearance and feel) aspects of the coating as well as general approval/disapproval based on their experience with the technology. A scale of -5(worst) to +5(best), with 0 representing neutral was used, representing a dimensionless quantity based on staff's personal preferences. Mean of the user's response to each question was used for quantification. The users observed the technology during the entire 12 weeks of the study period (during all 3 phases of data collection). Users were give a 4-week time period to submit their survey responses.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong University of Science and Technology

Collaborators

Queen Elizabeth Hospital, Hong Kong
Kowloon Hospital, Hong Kong
Innovation and Technology Commission, Hong Kong

Investigators

  • Principal Investigator: King Lun Yeung, PhD, Hong Kong University of Science and Technology
  • Study Chair: Chritropher Lai, MBChB, FRCP, Kowloon Hospital
  • Study Director: Dominic Tsang, MBChB, FRCP, Kowloon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (ACTUAL)

January 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITT/008/15GP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is under discussion and final decision will be made later.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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