Clinical performance and cost-effectiveness of a Silicone foam with 3DFit™ technology in chronic wounds compared with standard of care: An open randomised multicentre investigation

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.