Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 10550 for:    Anti-Infective Agents AND Bacterial

A Multi-level Antimicrobial Surface Coating for a Healthier Environment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795090
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Collaborators:
Kowloon Hospital, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Innovation and Technology Commission, Hong Kong
Information provided by (Responsible Party):
King Lun Yeung, Hong Kong University of Science and Technology

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hospital Acquired Infections Combination Product: Regular Patient privacy curtain Combination Product: Antimicrobial Coated curtains Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Phase 1, even numbers in coding are treatment and odd coded curtains are control (Blind) Phase 2, odd numbers in coding are treatment and even coded curtains are control (Blind) Phase 3, even numbers in coding are treatment and odd coded curtains are control (Blind)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study is complete blind as only principal investigator knows the coding on curtains and he can differentiate between two physically similar looking patient privacy curtains.
Primary Purpose: Prevention
Official Title: A Multi-level Antimicrobial Surface Coating for a Healthier Environment
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795090


Locations
Layout table for location information
Hong Kong
Kowloon Hospital
Kowloon, Hong Kong, 0000
Sponsors and Collaborators
Hong Kong University of Science and Technology
Kowloon Hospital, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Innovation and Technology Commission, Hong Kong
Investigators
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by King Lun Yeung, Hong Kong University of Science and Technology:

Publications:

Layout table for additonal information
Responsible Party: King Lun Yeung, Professor, Hong Kong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03795090     History of Changes
Other Study ID Numbers: ITT/008/15GP
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is under discussion and final decision will be made later.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King Lun Yeung, Hong Kong University of Science and Technology:
Antimicrobial coating, MDRO, MRSA, Patient Privacy Curtains
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents