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

This study has been completed.
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Ethne L Nussbaum, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01500174
First received: December 14, 2011
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Pressure Ulcer
 Device: ultraviolet therapy UV254
Device: Placebo ultraviolet therapy UV254

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Change in ulcer area relative to baseline [ Time Frame: At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean change in ulcer area between consecutive weeks [ Time Frame: At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Photographic Wound Assessment Tool (PWAT) [ Time Frame: From baseline to wound closure or when the subject is discharged from hospital ] [ Designated as safety issue: No ]
    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.

  • Change in Cardiff Wound Impact Schedule (CWIS) [ Time Frame: From baseline to wound closure or when subject is discharged from hospital ] [ Designated as safety issue: No ]
    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.

  • Follow-up wound status [ Time Frame: At 1, 6 and 12 months post-intervention ] [ Designated as safety issue: No ]
    Telephone interview - subjects were asked about status of study wounds - open or closed


Enrollment: 43
Study Start Date: November 2007
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active UVC device
Three times per week irradiation of wound base and periwound skin
 Device: ultraviolet therapy UV254
three times per week until wound closure or patient discharge from hospital
Placebo Comparator: Placebo UVC device
Three times per week irradiation of wound base and periwound skin
 Device: Placebo ultraviolet therapy UV254
Three times per week irradiation of wound base and periwound skin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500174

Locations
Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Ethne L Nussbaum, PhD Toronto Rehabilitation Institute
Principal Investigator: Colleen F McGillivray, MD, FRCPC Toronto Rehabilitation Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ethne L Nussbaum, Principle Investigator, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01500174     History of Changes
Other Study ID Numbers: SCI-2007-BDRST-465
Study First Received: December 14, 2011
Last Updated: September 4, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Toronto Rehabilitation Institute:
skin
decubitus
pressure
sore
spinal cord injury

Additional relevant MeSH terms:
Pressure Ulcer
Spinal Cord Injuries
Ulcer
Skin Ulcer
Skin Diseases
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013