A clinical investigation of a new gelling fibre dressing containing silver for the management of partial-thickness burns
Published Date: 10th October 2025
Publication Authors: Shokrollahi. K
Objective: To evaluate the performance and safety of Biatain Fiber Ag (Coloplast A/S, Denmark), a new gelling fibre wound dressing containing silver, based on percentage of wounds healed in partial-thickness burns within two weeks.
Method: This non-comparative, one-armed, open-labelled, multicentre study, included patients from five different sites in the UK between October 2023 and April 2024. The primary endpoint was whether a wound healed or not. Adverse events were also assessed.
Results: In total, 51 patients with a partial-thickness burn wound that was either infected or at risk of infection, and with medium-to-high levels of exudate, were part of the full analysis set. The proportion of wounds healed within two weeks of treatment was 83.7% (95% confidence interval (CI): 69.3, 93.2) of the 43 patients completing the investigation. In a post hoc sensitivity analysis, assuming that missing data on wound healing were either missing at random or corresponded to a non-healed wound, the estimated proportion of wounds healed was 74.8% (95% CI: 60.7, 85.1). In the pre-planned sensitivity analysis, where all missing data on wound healing were assumed to correspond to a non-healed wound, it was 70.6% (95% CI: 56.2, 82.5). A total of seven adverse events were found related to the investigational device; all were non-serious.
Conclusion: In this study, treatment of partial-thickness burns with the investigational device showed that the percentage of healed wounds within two weeks was comparable to the performance of similar products. In addition, the results revealed no safety concerns. This new gelling fibre wound dressing containing silver may therefore have a notable clinical implication for wound healing in patients with acute wounds that are infected or at risk of infection.
Lewis, C.J., Shokrollahi, K. et al. (2025). A clinical investigation of a new gelling fibre dressing containing silver for the management of partial-thickness burns. Journal of Wound Care. 34(10), pp.797-804. [Online]. Available at: https://doi.org/10.12968/jowc.2025.0233 [Accessed 15 October 2025].
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