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Ultraviolet-c irradiation in the management of pressure ulcers in people with spinal cord injury: a randomized, placebo-controlled trial
Nussbaum EL, Flett H, Hitzig SL, McGillivray C, Leber D, Morris H, Jing F
Archives of Physical Medicine and Rehabilitation 2013 Apr;94(4):650-659
clinical trial
10/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To compare the effects of ultraviolet-C (UVC) with placebo-UVC on pressure ulcer healing in individuals with spinal cord injury (SCI). DESIGN: Double-blind randomized trial with stratification for ulcer location to buttock or lower extremity. Subjects were followed up for 1 year postintervention. SETTING: Rehabilitation institution. PARTICIPANTS: Adult inpatients and outpatients (n = 43) with SCI and stage 2 to 4 pressure ulcers (n = 58). INTERVENTIONS: Ulcers and periwound skin were irradiated 3 times per week using UVC or placebo-UVC. The endpoint was wound closure or hospital discharge without closure. MAIN OUTCOME MEASURES: Primary outcome was weekly percent area relative to baseline. Secondary outcomes were mean percent area change between consecutive weeks, surface appearance, weeks to closure, and impact on quality of life and wound status postintervention. RESULTS: Groups were similar at baseline for all demographic characteristics except ulcer duration (p = 0.02). Groups were similar when healing was compared overall. Subgroup analysis showed that the percent area relative to baseline for stage 2 buttock ulcers was significantly smaller in the group receiving UVC compared with placebo at weeks 3, 5, and 7. During weeks 1 through 8, these ulcers were 26% to 76% of baseline area using UVC versus 111% to 180% for placebo (achieved significant level (ASL) 0.03 to 0.08; effect size 0.5 to 0.8). Groups were similar in the percent area relative to baseline for stage 2 lower extremity ulcers. Group mean percent area change between consecutive weeks for all stage 2 ulcers was 36.6% with the use of UVC and 5.8% for placebo (ASL = 0.09). There were no group differences in the percent area relative to baseline and the mean percent area change between consecutive weeks for stage 3 to 4 ulcers. Groups were similar for all other secondary outcomes. CONCLUSIONS: UVC is beneficial for stage 2 buttock ulcers. Further studies are warranted using a larger sample size, carefully considered exclusion criteria, and strategies to ensure homogeneity of the groups that are being compared.

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