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

Toronto Rehabilitation Institute

Status: Completed

Conditions: Pressure Ulcer

Treatments: Device: ultraviolet therapy UV254; Device: Placebo ultraviolet therapy UV254

Study type: Interventional

Funder types: Other

Identifiers

NCT01500174

SCI-2007-BDRST-465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

active UVC device

Experimental group

Description:

Three times per week irradiation of wound base and periwound skin

Treatment:

Device: ultraviolet therapy UV254

Placebo UVC device

Placebo Comparator group

Description:

Three times per week irradiation of wound base and periwound skin

Treatment:

Device: Placebo ultraviolet therapy UV254