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

NCT01500174 | Completed

• 1 other identifier: SCI-2007-BDRST-465
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

skin; decubitus; pressure; sore; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Change in Photographic Wound Assessment Tool (PWAT)

  From baseline to wound closure or when the subject is discharged from hospital

• Change in Cardiff Wound Impact Schedule (CWIS)

  From baseline to wound closure or when subject is discharged from hospital

• Follow-up wound status

  At 1, 6 and 12 months post-intervention

Study Arms (2)

active UVC device

EXPERIMENTAL

Three times per week irradiation of wound base and periwound skin

Device: ultraviolet therapy UV254

Placebo UVC device

PLACEBO COMPARATOR

Three times per week irradiation of wound base and periwound skin

Device: Placebo ultraviolet therapy UV254

Interventions

ultraviolet therapy UV254 DEVICE

three times per week until wound closure or patient discharge from hospital

active UVC device

Placebo ultraviolet therapy UV254 DEVICE

Three times per week irradiation of wound base and periwound skin

Placebo UVC device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• traumatic, non-traumatic or congenital spinal cord injury C2-L2
• pressure ulcer stage 2 or higher

You may not qualify if:

• neoplastic wound
• wound surgically repaired within past 3 months
• wound currently treated with negative pressure therapy

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

Location

Related Publications (2)

• 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.

  PMID: 8066108 BACKGROUND

• 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.

  PMID: 23246896 DERIVED

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ethne L Nussbaum, PhD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

• Colleen F McGillivray, MD, FRCPC

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 28, 2011
• Study Start: November 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

CA (1)