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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Bacterial colony forming unit counts
Study Overview
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
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: SafeZoneUVC (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported