Clinical trial NCT01500174: Ultraviolet-C Effectiveness in the Management of Pressure Ulcers in People With Spinal Cord Injury
Official title: Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: skin
decubitus
pressure
sore
spinal cord injury
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
First posted: 2011-12-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ulcer area relative to baseline
timeFrame: At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks
Secondary outcomes:
measure: Mean change in ulcer area between consecutive weeks
timeFrame: At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks
measure: Change in Photographic Wound Assessment Tool (PWAT)
timeFrame: From baseline to wound closure or when the subject is discharged from hospital
measure: Change in Cardiff Wound Impact Schedule (CWIS)
timeFrame: From baseline to wound closure or when subject is discharged from hospital
measure: Follow-up wound status
timeFrame: At 1, 6 and 12 months post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Ethne L Nussbaum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Rehabilitation Institute
name: Colleen F McGillivray, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.