Evaluation of a chitosan-based wound healing gel on acute/hard-to-heal wounds: a single cohort non-comparative clinical pilot study

Objective: This study investigated the safety and real-world effectiveness of a chitosan-based wound healing gel on a variety of acute and hard-to-heal wounds. Method: In this single cohort non-comparative clinical pilot study, ChitoCare Medical Triketra (Primex ehf, Iceland), a chitosan-based wound healing gel intended for the treatment of acute and hard-to-heal wounds and other skin conditions, was assessed for its safety and effectiveness in the management of a variety of acute and hard-to-heal wounds across a four-week evaluation period. Results: A total of 97 patients with 131 wounds were enrolled in the study, and a total of 89 wounds were included in the final analysis. The median relative wound area reduction was 39.2% for all wounds. At the end of the evaluation period, 68.4% of all wounds had improved. Median wound area decreased from 2.0cm 2 to 0.75cm 2 . Mean coverage of the wound bed for all wounds with devitalised tissue (necrosis and slough) at baseline was 39.4%, which reduced to 16.3% at the final visit. An improvement in pain severity experienced (i.e., a reduction in pain) was reported for 48.6% of wounds. A high level of satisfaction was reported by clinicians with the chitosan-based wound healing gel, and 97.1% of clinicians indicated that they would recommend it to other healthcare professionals. Conclusion: The results of this study showed that the chitosan-based wound healing gel was associated with wound progression, improvements in the condition of the wound bed and periwound skin, and a reduction in pain. These improvements, as well as a favourable safety profile, provide real-world evidence supporting the use of this chitosan-based wound healing gel in the treatment of acute and hard-to-heal wounds.