Voegeli David, Landauro Malene Hornbak, Sperup Trine, Ayoub Nayla, McRobert John William
Faculty Health & Wellbeing, University of Winchester, Winchester, UK.
Coloplast A/S, Humlebaek, Denmark.
Int Wound J. 2024 Dec;21(12):e70074. doi: 10.1111/iwj.70074.
The objective of the study was to show the clinical performance and cost-effectiveness of a Silicone foam dressing with 3DFit™ Technology compared to current standard of care. This was an open-labelled, two-arm, randomised controlled multicentre study conducted from February to December 2023. One hundred and two participants with an exuding, non-infected and chronic ulcer were randomised in a 1:1 fashion and treated with either a Silicone foam with 3DFit™ Technology or standard of care (a filler combined with a secondary dressing), stratified by venous leg ulcers and diabetic foot ulcers. After a 4-week study period, wound size and total costs were evaluated. After 4 weeks of treatment, a comparable percentage in wound area reduction was observed in both treatment arms with mean and 95% confidence interval of 54.3% (37.1%; 71.5%) and 43.0% (26.5%; 59.6%) for the investigational and comparator dressing, respectively. This corresponded to a mean difference of 11.3% ([-10.22; 32.86], p = 0.299). Total mean estimated costs were significantly lower for the investigational dressing (£14.3, 95% confidence interval [£9.6; £19.0]) compared to the two-dressing regime (£21.4 [£16.9; £26.0]), corresponding to a 33% price reduction (p = 0.033) after 4 weeks of treatment. With this RCT, a conforming Silicone foam dressing with 3DFit™ Technology was shown to be clinically comparable and a cost-effective alternative to using a filler and a secondary dressing at a significantly lower cost in both venous leg ulcers and diabetic foot ulcers up to 2 cm in depth.
本研究的目的是展示一种采用3DFit™技术的硅胶泡沫敷料相较于当前护理标准的临床性能和成本效益。这是一项开放标签、双臂、随机对照的多中心研究，于2023年2月至12月进行。102名患有渗出性、非感染性慢性溃疡的参与者以1:1的比例随机分组，分别接受采用3DFit™技术的硅胶泡沫敷料或护理标准（一种填充物加二级敷料）治疗，并按静脉性腿部溃疡和糖尿病足溃疡进行分层。经过4周的研究期后，评估伤口大小和总成本。治疗4周后，两个治疗组的伤口面积减少百分比相当，研究用敷料和对照敷料的平均减少率及95%置信区间分别为54.3%（37.1%；71.5%）和43.0%（26.5%；59.6%）。这相当于平均差异为11.3%（[-10.22；32.86]，p = 0.299）。研究用敷料的总平均估计成本（14.3英镑，95%置信区间[9.6英镑；19.0英镑]）显著低于两种敷料联合使用的成本（21.4英镑[16.9英镑；26.0英镑]），相当于治疗4周后价格降低了33%（p = 0.033）。通过这项随机对照试验表明，对于深度达2厘米的静脉性腿部溃疡和糖尿病足溃疡，采用3DFit™技术的合格硅胶泡沫敷料在临床上具有可比性，并且是一种成本效益高的选择，其成本显著低于使用填充物和二级敷料。
