Brewin Mark, Docherty Sharon, Heaslip Vanessa, Breheny Katie, Pleat Jonathon, Rhodes Shelley, van Zuijlen Paul P M, Shah Mamta
Burns & Plastics, Salisbury NHS Foundation Trust, Salisbury, Wiltshire, SP2 8BJ, UK.
University of Bournemouth, Poole, Dorset, BH12 5BB, UK.
NIHR Open Res. 2022 Jan 18;2:1. doi: 10.3310/nihropenres.13234.1.
This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation. The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact. This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone. The difference is measured between baseline and six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm. The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone. The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS). Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews.
本文概述了一项未来三年将在英国多个中心开展的研究方案。这是一项由英国国家卫生研究院(NIHR)资助的患者受益研究(RfPB)。其目的是评估在瘢痕形成早期使用脉冲染料激光(PDL)治疗肥厚性烧伤瘢痕的有效性。目标是通过改善烧伤瘢痕的外观和质量,以及减轻其心理影响,来提高患者的生活质量。这是一项平行组随机对照试验,将PDL联合标准护理与单纯标准护理进行比较。测量基线与六个月随访之间的差异。招募对象为烧伤愈合后三个月内的患者;伤口显示有明确的肥厚性瘢痕形成潜力。在一项多中心研究中总共招募120名患者;随机以1:1的比例分配到每组。治疗组除接受标准护理外,每隔六周接受3次PDL治疗,而对照组仅接受标准护理。主要结局是患者和观察者瘢痕量表(POSAS)中患者自评部分。使用CARe烧伤量表(英国布里斯托尔西英格兰大学)评估心理和心理社会影响,并使用简短健康调查问卷(SF-12)确定质量调整生命年(QALY)。该研究通过经济分析评估成本效益,并通过电话访谈评估患者报告的治疗体验。
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