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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500174
• Other study ID #: SCI-2007-BDRST-465
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: September 4, 2012
• Start date: November 2007
• Est. completion date: May 2011

Study information

• Verified date: September 2012
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Spinal Cord Injuries
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No