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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01500174
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : September 5, 2012
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Ethne L Nussbaum, Toronto Rehabilitation Institute

Tracking Information
First Submitted Date  ICMJE December 14, 2011
First Posted Date  ICMJE December 28, 2011
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE November 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)		 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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • 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 ]
    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 ]
    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 ]
    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 ]
    Telephone interview - subjects were asked about status of study wounds - open or closed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultraviolet-C Effectiveness in the Management of Pressure Ulcers in People With Spinal Cord Injury
Official Title  ICMJE Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pressure Ulcer
Intervention  ICMJE
  • Device: ultraviolet therapy UV254
    three times per week until wound closure or patient discharge from hospital
  • Device: Placebo ultraviolet therapy UV254
    Three times per week irradiation of wound base and periwound skin
Study Arms  ICMJE
  • Experimental: active UVC device
    Three times per week irradiation of wound base and periwound skin
    Intervention: Device: ultraviolet therapy UV254
  • Placebo Comparator: Placebo UVC device
    Three times per week irradiation of wound base and periwound skin
    Intervention: Device: Placebo ultraviolet therapy UV254
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)		 43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01500174
Other Study ID Numbers  ICMJE SCI-2007-BDRST-465
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ethne L Nussbaum, Toronto Rehabilitation Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Toronto Rehabilitation Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ontario Neurotrauma Foundation
Investigators  ICMJE
Principal Investigator: Ethne L Nussbaum, PhD Toronto Rehabilitation Institute
Principal Investigator: Colleen F McGillivray, MD, FRCPC Toronto Rehabilitation Institute
PRS Account Toronto Rehabilitation Institute
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP