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Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device

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: NCT03526068
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
USHIO. INC
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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Brief Summary:
The threat of MRSA and multi-drug resistant pathogens have been growing in recent years. A new means of countering the infectious threat is required and one such modality is the use of UV light for disinfection. The aim of the study is to proof the efficacy of the 222nm UV light in disinfection on patients with sacral sores. This is a first in human proof-of-concept study

Condition or disease Intervention/treatment Phase
Ultraviolet Rays Device: SafeZoneUVC Not Applicable

Detailed Description:

Recent outbreaks of Ebola and MERS, and in the trend of growing threat of MRSA and multi-drug resistant pathogens, it is clear that a new means of countering the infectious threat is needed - even the US, EU, and Korean hospitals with the latest facilities has failed to stop the spread of these pathogens inside their wards.

This novel "Harmless UV Light," operating within the "Safe Zone Wave Length," will be a disruptive technology to counter the growing threats of infectious diseases, such as multi-drug-resistant bacteria and also viruses such as Ebola, MERS and new type Influenza. It will be a disruptive device in that it aims to be applied to fast, effective and labor-free disinfection of living environments, such as hospital wards, airports, and other public spaces to stop the spread of pathogens. This research is the first human clinical trial using this device that will spearhead the development of this technology, providing the key starting clinical data which would be the lead to development for a wider range of indications and markets. Successful proof of concept will lead to the next stage collaboration of larger scale clinical trials, and trials targeting wider range of indications and markets, at NUHS.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The First in the World Human Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SafeZoneUVC
Patients were subjected to 90s UV light therapy of 540 mW/cm2 sessions 2 times a week for 2 weeks for a total of 4 sessions. Pre and post UV light therapy swabs were taken after standard wound irrigation
 Device: SafeZoneUVC
SafeZoneUVC® uses a Krypton Chloride (Kr-Cl) excimer lamp as its light source. The Kr-Cl excimer lamp emits UVC light having a main wavelength of 222 nm when the Kr-Cl exciplex is deactivated to non-excited state molecule in the lamp. This 222 nm UVC light can inactivate bacteria, while the Kr-Cl excimer lamp also emits UVC light having a wavelength of 230 nm or more. SafeZoneUVC® effectively eliminates UVC light with a wavelength of 230 nm or more by incorporating an appropriate optical filter inside the unit and also utilizing an opaque guide to ensure that light is not dispersed beyond the target area.


Outcome Measures
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Primary Outcome Measures :
  1. Bacterial colony forming unit counts [ Time Frame: Up to 2 weeks for completion of 4 sessions of UV therapy ]
    bacterial colony-forming unit (cfu) counts for the pre and post UV therapy swabs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients with pressure sore estimate at 2 cm X 2 cm or bigger
  2. Patients with grade 2 or 3 sacral sores

Exclusion Criteria:

  1. Patient who has pressure sore exposing bone
  2. Patient who are beyond the age limits
  3. Patient who is septic
  4. Patient with obviously infected wound / pus in the wound
  5. Patient who is pregnant.
Contacts and Locations
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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): NCT03526068


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
USHIO. INC
  Study Documents (Full-Text)

Documents provided by National University Hospital, Singapore:
Study Protocol  [PDF] October 16, 2016

More Information
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03526068    
Other Study ID Numbers: 2016/00105-AMD0001
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No