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.