Bull Richard Hillson, Staines Karen Louise, Collarte Agnes Juguilon, Bain Duncan Shirreffs, Ivins Nicola M, Harding Keith Gordon
Accelerate CIC, Centenary Wing, St Joseph's Hospice, London, UK.
Education and Research/Clinical Lead Wound Care, Accelerate CIC, Centenary Wing, St Joseph's Hospice, London, UK.
Int Wound J. 2022 May;19(4):734-740. doi: 10.1111/iwj.13669. Epub 2021 Aug 10.
Complete healing is problematic as an endpoint for evaluating interventions for wound healing. The great heterogeneity of wounds makes it difficult to match groups, and this is only possible with multivariate stratification and/or very large numbers of subjects. The substantial time taken for wounds to heal necessitates a very lengthy study. Consequently, high quality randomised controlled trials demonstrating an effect of an intervention to a satisfactory level of statistical significance and with a satisfactory level of generalisability are extremely rare. This study determines that the healing of venous leg ulcers receiving multi-component compression bandaging follows a linear trajectory over a 4-week period, as measured by gross area healed, percentage area healed, and advance of the wound margin. The linear trajectories of these surrogates make it possible to identify an acceleration in healing resulting from an intervention, and allows self-controlled or crossover designs with attendant advantages of statistical power and speed. Of the metrics investigated, wound margin advance was the most linear, and was also independent of initial ulcer size.
将完全愈合作为评估伤口愈合干预措施的终点存在问题。伤口的巨大异质性使得难以匹配各组，只有通过多变量分层和/或大量受试者才有可能做到。伤口愈合所需的大量时间使得研究必须非常漫长。因此，高质量的随机对照试验极为罕见，这些试验要证明一种干预措施的效果达到令人满意的统计学显著性水平且具有令人满意的可推广性。本研究确定，接受多成分加压绷带治疗的下肢静脉溃疡在4周内的愈合呈线性轨迹，这通过愈合的总面积、愈合面积百分比和伤口边缘的进展来衡量。这些替代指标的线性轨迹使得能够识别干预导致的愈合加速，并允许采用具有统计学效力和速度等相关优势的自身对照或交叉设计。在所研究的指标中，伤口边缘进展最呈线性，并且也与初始溃疡大小无关。
