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

Not Applicable

Completed

• Conditions: Ultraviolet Rays
• Interventions: Device: SafeZoneUVC

• Registration Number: NCT03526068
• Lead Sponsor: National University Hospital, Singapore

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 Timeline

• Study Start: 2016-12
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-16
• Primary Completion: 2019-01-23
• Study Completion: 2019-01-23
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SafeZoneUVC	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

Primary Outcome Measures

Name	Time	Method
Bacterial colony forming unit counts	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

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore