Pressure Ulcer
Conditions
Keywords
skin, decubitus, pressure, sore, spinal cord injury
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.
Interventions
DEVICEultraviolet therapy UV254
three times per week until wound closure or patient discharge from hospital
DEVICEPlacebo ultraviolet therapy UV254
Three times per week irradiation of wound base and periwound skin
Sponsors
Ontario Neurotrauma Foundation
Toronto Rehabilitation Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed