Prospective testing of the effectiveness and safety of using a medical device “Wound coating based on the NovoSkin collagen-laminate matrix”

   The study examines the effectiveness and safety of the medical device “Wound coating based on the NovoSkin collagen-laminate matrix”, conducted from February to May 2024 at the Ryazan State Medical University (Ryazan, Russia).

   Purpose of a study: to evaluate the use of wound coating NovoSkin in patients with skin defects.

   Materials and methods. NovoSkin is a sterile, round-shaped coating with a uniform matte and transparent surface. It is made of type 1 collagen and laminin, using safe ingredients, which makes it biocompatible and absorbable within 10–14 days. The use of the coating is indicated for burns of I–III degrees, trophic ulcers and pressure sores, however, it is contraindicated in open bleeding wounds and hypersensitivity to the components. The study included 60 patients (28 men (46.67 %) were and 32 women (53.33 %)) aged from 27 to 92 years (mean age (66.8 ± ± 12.4) years old). The main procedures included demographic data collection, local screening, vital signs assessment, and NovoSkin application. Efficacy was assessed by the percentage of patients with an increase in granulation area of at least 20 % by day 14.

   The results. Absolute majority (96.67 %) of patients showed a significant increase in granulations, indicating a high coverage efficiency. The safety of the application was assessed through the frequency of undesirable events and changes in vital signs. No serious adverse events have been reported, which confirms NovoSkin’s good tolerability.

   Conclusion. NovoSkin wound coating has demonstrated high efficacy and safety in the treatment of skin defects, which makes it a promising tool in clinical practice. The test results confirm the product’s compliance with established standards and its feasibility for use in medical institutions.

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