Ultraviolet-C Effectiveness in the Management of Pressure Ulcers in People With Spinal Cord Injury

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Device: ultraviolet therapy UV254; Device: Placebo ultraviolet therapy UV254

• Registration Number: NCT01500174
• Lead Sponsor: Toronto Rehabilitation Institute

Brief Summary

The objective of the study is to examine the effectiveness of Ultraviolet-C (UVC) for healing pressure ulcers in people with spinal cord injury. UVC is a form of radiation similar to sunlight but it is normally absorbed in the earth's atmosphere. Participants will be assigned by chance to receive placebo-UVC or real UVC treatment, in addition to receiving wound care according to best practice guidelines. The hypothesis is that UVC-treated wounds will heal at a faster rate than wounds receiving placebo treatment.

Given that pressure ulcers impact on an individual's quality of life, and generate high costs to the overall health care system, further work is needed to explore alternative means of pressure ulcer treatment.

Detailed Description

UVC or placebo UVC will be applied to wounds three times per week. Intact skin around the wound edge and the wound base will be irradiated.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-28
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• traumatic, non-traumatic or congenital spinal cord injury C2-L2
• pressure ulcer stage 2 or higher

Exclusion Criteria

• neoplastic wound
• wound surgically repaired within past 3 months
• wound currently treated with negative pressure therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active UVC device	ultraviolet therapy UV254	Three times per week irradiation of wound base and periwound skin
Placebo UVC device	Placebo ultraviolet therapy UV254	Three times per week irradiation of wound base and periwound skin

Primary Outcome Measures

Name	Time	Method
Change in ulcer area relative to baseline	At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks	Wounds are photographed at baseline and measurement is repeated every week either until the wound is closed or the subject is discharged from hospital, up to a maximum of 32 weeks. A metric reference is fixed to skin adjacent to the wound. A blinded assessor measures area directly from the number-coded images using digital software. Percent change is calculated each week relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Mean change in ulcer area between consecutive weeks	At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks	Wounds are photographed at baseline and measurement is repeated every week either until the wound is closed or the subject is discharged from hospital, up to a maximum of 32 weeks. A metric reference is fixed to skin adjacent to the wound. A blinded assessor measures area directly from the number-coded images using digital software. Percent change in area relative to the previous measurement is calculated each week for the individual and then averaged for the individual over all weeks of the study.
Change in Photographic Wound Assessment Tool (PWAT)	From baseline to wound closure or when the subject is discharged from hospital	The PWAT characterizes six aspects of wound appearance (wound edge, necrotic tissue type and amount, skin colour, granulation tissue and epithelialization), and yields scores ranging from 0-24, where higher scores indicate more severe wounds. A blinded assessor scored the PWAT using the number-coded images.
Change in Cardiff Wound Impact Schedule (CWIS)	From baseline to wound closure or when subject is discharged from hospital	The CWIS is a condition-specific quality of life (QOL) tool that evaluates wound impact on four domains: overall QOL, well-being, physical experience and the perceived stress of the physical experience.
Follow-up wound status	At 1, 6 and 12 months post-intervention	Telephone interview - subjects were asked about status of study wounds - open or closed

Trial Locations

Locations (1)

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada