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

Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: ultraviolet therapy UV254; Device: Placebo ultraviolet therapy UV254

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3V9
      • Toronto Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active UVC device; Three times per week irradiation of wound base and periwound skin	Device: ultraviolet therapy UV254; three times per week until wound closure or patient discharge from hospital
Placebo Comparator: Placebo UVC device; Three times per week irradiation of wound base and periwound skin	Device: Placebo ultraviolet therapy UV254; Three times per week irradiation of wound base and periwound skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ulcer area relative to baseline	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.	At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in ulcer area between consecutive 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.	At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks
Change in Photographic Wound Assessment Tool (PWAT)	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.	From baseline to wound closure or when the subject is discharged from hospital
Change in Cardiff Wound Impact Schedule (CWIS)	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.	From baseline to wound closure or when subject is discharged from hospital
Follow-up wound status	Telephone interview - subjects were asked about status of study wounds - open or closed	At 1, 6 and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Toronto Rehabilitation Institute
• Collaborators: Ontario Neurotrauma Foundation
• Investigators: Principal Investigator: Ethne L Nussbaum, PhD, Toronto Rehabilitation Institute; Principal Investigator: Colleen F McGillivray, MD, FRCPC, Toronto Rehabilitation Institute

Publications and helpful links

General Publications

• Nussbaum EL, Biemann I, Mustard B. Comparison of ultrasound/ultraviolet-C and laser for treatment of pressure ulcers in patients with spinal cord injury. Phys Ther. 1994 Sep;74(9):812-23; discussion 824-5. doi: 10.1093/ptj/74.9.812.
• Nussbaum EL, Flett H, Hitzig SL, McGillivray C, Leber D, Morris H, Jing F. Ultraviolet-C irradiation in the management of pressure ulcers in people with spinal cord injury: a randomized, placebo-controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):650-9. doi: 10.1016/j.apmr.2012.12.003. Epub 2012 Dec 13.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 28, 2011

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 4, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: skin; pressure; spinal cord injury; decubitus; sore
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Wounds and Injuries; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Ulcer; Spinal Cord Injuries; Pressure Ulcer
• Other Study ID Numbers: SCI-2007-BDRST-465