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

• Mean change in ulcer area between consecutive weeks [ Time Frame: At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks ] [ Designated as safety issue: No ]
  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) [ Time Frame: From baseline to wound closure or when the subject is discharged from hospital ] [ Designated as safety issue: No ]
  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) [ Time Frame: From baseline to wound closure or when subject is discharged from hospital ] [ Designated as safety issue: No ]
  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 [ Time Frame: At 1, 6 and 12 months post-intervention ] [ Designated as safety issue: No ]
  Telephone interview - subjects were asked about status of study wounds - open or closed

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.

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.

• Device: ultraviolet therapy UV254
  three times per week until wound closure or patient discharge from hospital
• Device: Placebo ultraviolet therapy UV254
  Three times per week irradiation of wound base and periwound skin

• Experimental: active UVC device
  Three times per week irradiation of wound base and periwound skin
  Intervention: Device: ultraviolet therapy UV254
• Placebo Comparator: Placebo UVC device
  Three times per week irradiation of wound base and periwound skin
  Intervention: Device: Placebo ultraviolet therapy UV254

• 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.
• 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.

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