Purcell Anne, Buckley Thomas, Fethney Judith, King Jennie, Moyle Wendy, Marshall Andrea P
1 Griffith University, QLD, Australia.
2 Central Coast Local Health District, NSW, Australia.
Int J Low Extrem Wounds. 2017 Sep;16(3):163-172. doi: 10.1177/1534734617726678. Epub 2017 Aug 24.
This study aimed to evaluate the effect of EMLA 5% cream applied to painful chronic leg ulcers (CLUs) as a primary dressing on wound healing and health-related quality of life (HRQoL). A pilot, parallel-group, nonblinded, randomized controlled trial was conducted in 6 community nursing procedure clinics in New South Wales, Australia. A total of 60 participants with painful CLUs of varied etiology were randomly assigned to the intervention (EMLA daily for 4 weeks as a primary dressing, followed by usual care) or usual care only. Wound size and HRQoL were measured at baseline, end of the intervention period (week 4), and week 12. At baseline, wound sizes were similar for both the intervention and control groups. During the intervention period, there was no significant difference in wound sizes between groups (intervention group: median (cm) = 2.4, IQR = 1.3-12.7; control group: median (cm) = 5.0, IQR = 2.5-9.9; P = .05). Mean HRQoL scores for all subscales at baseline and weeks 4 and 12 were similar between groups except for Wellbeing, which was significantly higher in the intervention group at the end of the 4-week intervention period (intervention group: mean = 52.41, SD = 24.50; control group: mean = 38.15, SD = 21.25; P = .03; d = 0.62). The trial findings suggest that daily applications of EMLA as a primary dressing do not inhibit wound healing and may improve patient well-being. Studies with larger samples are required to more comprehensively evaluate the impact of this treatment on wound healing and HRQoL.
本研究旨在评估5%复方利多卡因乳膏作为主要敷料应用于疼痛性慢性腿部溃疡(CLU)对伤口愈合及健康相关生活质量(HRQoL)的影响。在澳大利亚新南威尔士州的6家社区护理程序诊所进行了一项先导性、平行组、非盲、随机对照试验。共有60名病因各异的疼痛性CLU患者被随机分配至干预组(每日使用复方利多卡因乳膏作为主要敷料,持续4周,之后进行常规护理)或仅接受常规护理。在基线、干预期结束时(第4周)和第12周测量伤口大小及HRQoL。基线时,干预组和对照组的伤口大小相似。在干预期内,两组间伤口大小无显著差异(干预组:中位数(cm)=2.4,四分位数间距=1.3 - 12.7;对照组:中位数(cm)=5.0,四分位数间距=2.5 - 9.9;P = 0.05)。除幸福感外,两组在基线、第4周和第12周时所有子量表的平均HRQoL得分相似,在4周干预期结束时,干预组的幸福感显著更高(干预组:均值=52.41,标准差=24.50;对照组:均值=38.15,标准差=21.25;P = 0.03;效应量d = 0.62)。试验结果表明,每日使用复方利多卡因乳膏作为主要敷料不会抑制伤口愈合,且可能改善患者的幸福感。需要更大样本量的研究来更全面地评估这种治疗对伤口愈合及HRQoL的影响。
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