A Multi-level Antimicrobial Surface Coating for a Healthier Environment

NCT03795090 | Completed Phase 2 DMC

• 1 other identifier: ITT/008/15GP
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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).

Conditions

Hospital Acquired Infections

Keywords

Antimicrobial coating, MDRO, MRSA, Patient Privacy Curtains

Outcome Measures

Primary Outcomes (2)

• Change in total bacteria count and MRSA in control vs treatment patient privacy curtains

  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

  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 Outcomes (1)

• Agreement/disagreement of hospital staff regarding technology acceptance and adaptation

  4 weeks

Study Arms (2)

Regular Patient privacy curtain

ACTIVE COMPARATOR

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

Antimicrobial Coated Curtains

EXPERIMENTAL

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; Combination Product: Antimicrobial Coated curtains

Interventions

Regular Patient privacy curtain COMBINATION_PRODUCT

Laundered curtains, used in the hospital, coming from the hospital inventory.

Antimicrobial Coated Curtains; Regular Patient privacy curtain

Antimicrobial Coated curtains COMBINATION_PRODUCT

Antimicrobial coating consist of active polymers that are approved by USFDA and USEPA.

Antimicrobial Coated Curtains

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong University of Science and Technology: lead
• Kowloon Hospital, Hong Kong: collaborator
• Queen Elizabeth Hospital, Hong Kong: collaborator
• Innovation and Technology Commission, Hong Kong: collaborator

Study Sites (1)

Kowloon Hospital

Kowloon, 0000, Hong Kong

Location

Related Publications (7)

• Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis. 2007 Dec;13(12):1840-6. doi: 10.3201/eid1312.070629.

  PMID: 18258033 BACKGROUND

• de Kraker ME, Davey PG, Grundmann H; BURDEN study group. Mortality and hospital stay associated with resistant Staphylococcus aureus and Escherichia coli bacteremia: estimating the burden of antibiotic resistance in Europe. PLoS Med. 2011 Oct;8(10):e1001104. doi: 10.1371/journal.pmed.1001104. Epub 2011 Oct 11.

  PMID: 22022233 BACKGROUND

• Carling PC, Von Beheren S, Kim P, Woods C; Healthcare Environmental Hygiene Study Group. Intensive care unit environmental cleaning: an evaluation in sixteen hospitals using a novel assessment tool. J Hosp Infect. 2008 Jan;68(1):39-44. doi: 10.1016/j.jhin.2007.09.015. Epub 2007 Dec 11.

  PMID: 18069083 BACKGROUND

• Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.

  PMID: 17030826 BACKGROUND

• Datta R, Platt R, Yokoe DS, Huang SS. Environmental cleaning intervention and risk of acquiring multidrug-resistant organisms from prior room occupants. Arch Intern Med. 2011 Mar 28;171(6):491-4. doi: 10.1001/archinternmed.2011.64.

  PMID: 21444840 BACKGROUND

• Otter JA, Yezli S, Perl TM, Barbut F, French GL. The role of 'no-touch' automated room disinfection systems in infection prevention and control. J Hosp Infect. 2013 Jan;83(1):1-13. doi: 10.1016/j.jhin.2012.10.002. Epub 2012 Nov 26.

  PMID: 23195691 BACKGROUND

• Carling PC, Parry MM, Rupp ME, Po JL, Dick B, Von Beheren S; Healthcare Environmental Hygiene Study Group. Improving cleaning of the environment surrounding patients in 36 acute care hospitals. Infect Control Hosp Epidemiol. 2008 Nov;29(11):1035-41. doi: 10.1086/591940.

  PMID: 18851687 BACKGROUND

Study Officials

• King Lun Yeung, PhD

  Hong Kong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Chritropher Lai, MBChB, FRCP

  Kowloon Hospital

  STUDY CHAIR

• Dominic Tsang, MBChB, FRCP

  Kowloon Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: January 7, 2019
• Study Start: June 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

HK (1)