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

NCT ID: NCT01500174

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Pressure Ulcer

Keywords

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skin decubitus pressure sore spinal cord injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active UVC device

Three times per week irradiation of wound base and periwound skin

Group Type EXPERIMENTAL

ultraviolet therapy UV254

Intervention Type DEVICE

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

Placebo UVC device

Three times per week irradiation of wound base and periwound skin

Group Type PLACEBO_COMPARATOR

Placebo ultraviolet therapy UV254

Intervention Type DEVICE

Three times per week irradiation of wound base and periwound skin

Interventions

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ultraviolet therapy UV254

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

Intervention Type DEVICE

Placebo ultraviolet therapy UV254

Three times per week irradiation of wound base and periwound skin

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Neurotrauma Foundation

OTHER

Sponsor Role collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role lead

Responsible Party

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Ethne L Nussbaum

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ethne L Nussbaum, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Colleen F McGillivray, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Locations

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Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 8066108 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23246896 (View on PubMed)

Other Identifiers

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SCI-2007-BDRST-465

Identifier Type: -

Identifier Source: org_study_id