School of Engineering, Cardiff University, Queen's Buildings, The Parade, Cardiff, CF24 3AA, UK.
Cedar, Cardiff and Vale University Health Board, Cardiff Medicentre, Cardiff, CF14 4UJ, UK.
Appl Health Econ Health Policy. 2019 Apr;17(2):131-141. doi: 10.1007/s40258-018-00457-0.
The gold standard treatment for deep burns is an autologous skin graft; in larger burns this may be meshed to increase the area covered. However, long-term aesthetic and functional outcomes of graft scars may be poor. ReCell is a medical device that processes skin samples in the operating theatre into a cell suspension to be sprayed or dripped onto a wound. It is claimed to improve healing and scar appearance. This device was evaluated by the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme. Two groups were defined: ReCell compared to conventional dressings in shallower burns, and meshed grafts plus ReCell compared to meshed grafts alone in larger deeper burns. The manufacturer's clinical evidence submission included three papers and eight conference abstracts. The External Assessment Centre (EAC) excluded two of these and added seven abstracts. In general, the evidence did not fit the defined groups, but suggested that ReCell was clinically comparable to skin grafts for partial thickness burns; however, ReCell is not used in this way in the UK. The manufacturer submitted an economic model in which ReCell treatment of partial thickness burns reduced the requirement for later skin grafts. This indicated that ReCell alone was cost saving in comparison to conventional dressings. The EAC indicated that this model was clinically inappropriate, but data were not available to populate a new model. NICE Medical Technologies Guidance 21 recommended that additional research was needed to address the uncertainties regarding the potential benefits of ReCell.
深度烧伤的金标准治疗方法是自体皮肤移植;在较大面积的烧伤中,可能需要将其网织化以增加覆盖面积。然而,移植物疤痕的长期美观和功能结果可能不佳。ReCell 是一种医疗器械,可在手术室中将皮肤样本加工成细胞悬浮液,然后喷洒或滴注到伤口上。据称,它可以改善愈合和疤痕外观。该设备由英国国家卫生与保健优化研究所(NICE)医疗技术评估计划进行了评估。定义了两组:ReCell 与较浅烧伤中的传统敷料相比,以及网状移植物加 ReCell 与单独使用网状移植物相比在较大较深的烧伤中。制造商的临床证据提交包括三份文件和八份会议摘要。外部评估中心(EAC)排除了其中的两份,并添加了七份摘要。一般来说,证据不符合定义的组别,但表明 ReCell 与皮肤移植物在部分厚度烧伤方面具有临床可比性;然而,ReCell 在英国并未以这种方式使用。制造商提交了一个经济模型,其中 ReCell 治疗部分厚度烧伤减少了对后期皮肤移植的需求。这表明 ReCell 单独治疗与传统敷料相比具有成本效益。EAC 表示该模型在临床上不适用,但没有可用的数据来填充新模型。NICE 医疗技术指南 21 建议需要开展更多研究,以解决有关 ReCell 潜在益处的不确定性。