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

NCT03526068 | Completed

• 1 other identifier: 2016/00105-AMD0001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Ultraviolet Rays

Outcome Measures

Primary Outcomes (1)

• Bacterial colony forming unit counts

  bacterial colony-forming unit (cfu) counts for the pre and post UV therapy swabs

  Up to 2 weeks for completion of 4 sessions of UV therapy

Study Arms (1)

SafeZoneUVC

EXPERIMENTAL

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

Interventions

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.

SafeZoneUVC

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• USHIO. INC: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 16, 2018
• Study Start: December 1, 2016
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: February 15, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)