Octenidine with hyaluronan dressing versus a silver dressing in hard-to-heal wounds: a post-marketing study
Abstract
OBJECTIVE: This study was conducted to provide comparative data on the clinical efficacy and safety of a novel hard-to-heal wound dressing (Sorelex; Contipro a.s., Czech Republic) that combines octenidine and hyaluronan, compared with a silver-based dressing. METHOD: This multicentre, open-label, randomised, post-market, clinical follow-up study provides a comparison of a octenidine and hyaluronan combination with a standard-of-care (SoC) silver-containing dressing.
The investigators evaluated the management of infection in the hard-to-heal wounds based on recorded changes in the appearance of the wound bed tissue and the presence of clinical signs of infection after three weeks of treatment. Other relevant assessed parameters of wound healing were: wound size; exudation level; wound pain level; and surrounding skin appearance.
RESULTS: The study cohort included 48 patients in the Sorelex arm and 39 patients in the SoC arm. Both products evinced numerous parameters of wound infection management: reductions in the wound bed slough; marked decreases in wound size; the formation of re-epithelialisation and granulation tissue; and improved pain management.
Sorelex significantly improved the condition of surrounding skin after three weeks of treatment, unlike SoC. Sorelex reduced wound area significantly more than SoC (p=0.04).
No statistically significant differences were detected in other assessed parameters between the two study arms. All the participating investigators expressed their satisfaction with both products.
No adverse reactions to Sorelex were recorded over the mean treatment period of 53 days. CONCLUSION: The octenidine and hyaluronan combination provides a new alternative choice of dressing for the treatment of infected hard-to-heal wounds when compared with a silver-based product.