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

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ultraviolet therapy UV254
Placebo ultraviolet therapy UV254
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring skin, decubitus, pressure, sore, spinal cord injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active UVC device

Placebo UVC device

Arm Description

Three times per week irradiation of wound base and periwound skin

Three times per week irradiation of wound base and periwound skin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Follow-up wound status
Telephone interview - subjects were asked about status of study wounds - open or closed

Full Information

First Posted
December 14, 2011
Last Updated
September 4, 2012
Sponsor
Toronto Rehabilitation Institute
Collaborators
Ontario Neurotrauma Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01500174
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Ontario Neurotrauma Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
skin, decubitus, pressure, sore, spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active UVC device
Arm Type
Experimental
Arm Description
Three times per week irradiation of wound base and periwound skin
Arm Title
Placebo UVC device
Arm Type
Placebo Comparator
Arm Description
Three times per week irradiation of wound base and periwound skin
Intervention Type
Device
Intervention Name(s)
ultraviolet therapy UV254
Intervention Description
three times per week until wound closure or patient discharge from hospital
Intervention Type
Device
Intervention Name(s)
Placebo ultraviolet therapy UV254
Intervention Description
Three times per week irradiation of wound base and periwound skin
Primary Outcome Measure Information:
Title
Change in ulcer area relative to baseline
Description
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.
Time Frame
At baseline and repeated weekly up to wound closure or duration of hospital stay to a maximum of 32 weeks
Secondary Outcome Measure Information:
Title
Mean change in ulcer area between consecutive weeks
Description
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.
Time Frame
At baseline and repeated weekly up to wound closure or duration of hospital stay up to a maximum of 32 weeks
Title
Change in Photographic Wound Assessment Tool (PWAT)
Description
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.
Time Frame
From baseline to wound closure or when the subject is discharged from hospital
Title
Change in Cardiff Wound Impact Schedule (CWIS)
Description
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.
Time Frame
From baseline to wound closure or when subject is discharged from hospital
Title
Follow-up wound status
Description
Telephone interview - subjects were asked about status of study wounds - open or closed
Time Frame
At 1, 6 and 12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethne L Nussbaum, PhD
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Colleen F McGillivray, MD, FRCPC
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
8066108
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.
Results Reference
background
PubMed Identifier
23246896
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.
Results Reference
derived

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

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