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Chitosan-Based Haemostatic Systems (Axiostat): An Integrated Approach to Post-operative Wound Management in Vascular Surgery

Publication Details

Perri P, Curcio F, Piro P, Sole R, Leonetti AE, Giordano F, Fiorillo M, Manti EN, De Luca M, Trombino S, Cassano R. Chitosan-Based Haemostatic Systems (Axiostat): An Integrated Approach to Post-operative Wound Management in Vascular Surgery. Biomedical Materials & Devices. 2026 Aug 24:1-3.

Key Findings

  1. To evaluate the physicochemical properties and biological performance of the Axiostat.
  2.  In vivo application and efficacy of Axiostat in the management of bleeding wounds at the inguinal level, resulting from endovascular procedures for the treatment of chronic peripheral arterial disease (PAO).

Core Results

1. Antibacterial Activity Evaluation ​

  • The in-vitro testing demonstrated antibacterial activity against both Gram-positive and Gram-negative bacteria, namely Staphilococcus aureus, Streptococcus pyogenes, Klebisiella pneumoniae and Pseudomonas aeuruginosa 
  • Approximately 1 cm zone of inhibition was observed

2. Antioxidant activity

  • 82.5% DPPH radical-scavenging activity within just 30 minutes.
  • Reduced ROS levels indicate antioxidant activity and protection of epidermal cells from oxidative injury.

3. Swelling Studies

  • The stability of Axiostat’s swelling shows rapid absorption >96% water content within 10 minutes

4. Microscopical analysis

  • SEM analysis showed highly porous and interconnected 3D structure with the majority of pores size between 50 and 130 µm
  • Higher magnification of the surface: revealed a compact morphology with limited surface openings
  • Bilayer structure: dense outer layer + highly porous inner network

5. Biocompatibility evaluation and Cell Proliferation activity

  • No cytotoxic effect observed in HaCaT human keratinocytes under the tested conditions.
  • Increased cell proliferation with increasing extract concentration from 0.01–0.25 mg/mL.

6. Haemostatic & Clinical Performance

  • Primary technical success for haemostasis: 99.9% (patients with stage 2 AOCP); 98.5% (patients with other disease stages)
  • Median time to haemostasis: ~3 minutes
  • Ambulatory after 24 hours: 100%
  • Zero adverse events

Key Insights & Discussion

  1. Microscopical: Rapid fluid absorption indicates highly porous, interconnected structure draws in blood and wound fluid quickly, concentrating red blood cells and platelets at the bleeding site to support faster clot formation.
  2. Antibacterial: In-vitro activity against both Gram-positive and Gram-negative bacteria helps create a protective barrier that lowers the risk of infection at the wound or access site.
  3. Antioxidant: Demonstrated antioxidant activity through DPPH and reduced ROS levels supporting faster granulation and wound management
  4. Biocompatibility: No cytotoxic effect observed, with increased cell proliferation and migration, safe for contact with human tissue and supportive of the body's natural healing process.
  5. Clinical performance: High rates of successful bleeding control, early return to normal activity, and the absence of adverse events reflect reliable, safe real-world performance in patients.
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