Ultraviolet-C Irradiation in the Management of Pressure Ulcers in People With Spinal Cord Injury: A Randomized, Stratified, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in ulcer area relative to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic, non-traumatic or congenital spinal cord injury C2-L2
- •pressure ulcer stage 2 or higher
排除标准
- •neoplastic wound
- •wound surgically repaired within past 3 months
- •wound currently treated with negative pressure therapy
结局指标
主要结局
Change in ulcer area relative to baseline
时间窗: 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.
次要结局
- 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)
研究者
Ethne L Nussbaum
Principle Investigator
Toronto Rehabilitation Institute