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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: ultraviolet therapy UV254
* Device: Placebo ultraviolet therapy UV254


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin, decubitus, pressure, sore, spinal cord injury