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NCT Number: NCT03526068

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

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

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Key information

Conditions

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who has pressure sore exposing bone
  • Patient who are beyond the age limits
  • Patient who is septic
  • Patient with obviously infected wound / pus in the wound
  • Patient who is pregnant.

Treatment and study plan

SafeZoneUVC

Device

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • USHIO. INC

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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