Science and Technology
Discover how the materials and processing behind HemCon brand products achieve the unique hemostatic and antibacterial characteristics that set them apart from the competition.
HemCon® PRO Chitosan Technology:
Tricol Biomedical’s HemCon® PRO branded hemostatic products contain patented HemCon PRO chitosan (“ky-to-san”) technology. HemCon PRO chitosan technology uses pure chitosan biomaterial. The chitosan is a biocompatible polysaccharide extracted from the shells of wild caught shrimp harvested in the pristine waters of the North Atlantic.
HemCon PRO hemostatic products provide for clinically proven performance that quickly controls all bleeding including difficult anti-coagulated and hemorrhagic bleeding. HemCon PRO hemostatic products possess hemostatic activity that results from strong polycationic (positive) charge from the incorporated HemCon PRO chitosan. This positive charge correspondingly promotes binding with biopolymers, tissues, and cells possessing inherent negative charge. Such negatively charged biopolymers, tissues, and cells include other polysaccharides, proteins, oral mucosa, injured tissue surfaces, red blood cells, platelets, bacteria and viruses. HemCon PRO hemostatic product application results in rapid adherence to, and sealing of, injured tissue; promotion of clotting independent of the clotting cascade; and broad antibacterial activity.1,2 HemCon PRO hemostatic products have been demonstrated to effectively control bleeding in anticoagulated patient populations.3-8 HemCon PRO chitosan technology has been shown not to cause allergic responses in shrimp allergic individuals.9,10 Comparative preclinical studies demonstrate HemCon PRO chitosan technology has unique hemostatic properties, providing for superior hemostatic efficacy compared to other hemostatic materials such as minerals and cellulose (ORC) particularly for deep penetrating and high volume/high pressure arterial wounds.11,12
The antibacterial effectiveness within the HemCon PRO chitosan dressings has been investigated using an in vitro methodology, in which the antibacterial activities of chitosan were measured against a wider range of bacteria.1,2 Results demonstrate that chitosan increased permeability on the inner and outer membranes and ultimately disrupted the bacterial cell membranes, releasing their contents and killing the organism within the dressing. HemCon lyophilized hemostatic products offer barrier to bacterial penetration of the dressing, and the log reduction data demonstrates the level of antibacterial effectiveness within the dressing against at least 24 gram positive and gram negative organisms, including MRSA, VRE, C. difficile, and A. Baumannii. The clinical utility of these results is unknown.
HemCon PRO chitosan products are manufactured through 2 proprietary processes: lyophilizing (freeze-drying) and substrate coating.
- The unique chitosan dressing structure of the HemCon PRO Bandage products is obtained by low temperature freeze phase-separation of the HemCon PRO chitosan from solution. The solution is prepared beforehand as a chitosan gel. During the freeze separation process, controlled, alternating, micro-thin, sheet domains of ice and HemCon PRO chitosan are formed within the final solid frozen cake. Subsequent sublimation of the ice to gaseous water under low pressure and heat (the freeze drying or lyophilization part of the process) results in ice removal from the frozen cake with structural preservation of a dry, porous, interconnected HemCon PRO chitosan matrix. This chitosan matrix is then further processed and converted into the final HemCon products.
- The substrate coating technology involves uniform wetting of medical grade gauze with chitosan gel. The gel solution is formed from HemCon PRO chitosan. After the chitosan is wet coated onto the gauze, it is dried by evaporation to provide a uniform coating of chitosan on the gauze substrate. The chitosan coating provides for significant enhancement in gauze antibacterial barrier properties and bleeding control.
HemCon m.doc® technology:
Oxidized cellulose is cellulosic fibrous material that has been used globally in woundcare as a hemostatic biomaterial for at least 50 years. However due to its inherent insoluble fibrillar structure, traditional oxidized cellulose demonstrates limited consistency and problematic processability with resultant limited applicability. Tricol Biomedical has overcome these difficulties of traditional oxidized cellulose with its patented microdispersed oxidized cellulose (m.doc®) micronized salt form of oxidized cellulose. Tricol’s microdispersed oxidized cellulose is derived from plant based, non-GMO, cotton linters. Microdispersed oxidized cellulose from cotton linters is a high purity oxidized cellulose for biomedical applications including hemostasis (bleeding control), wound healing, and cosmeceutical use. m.doc is an extremely safe active hemostatic agent that works with the body’s natural coagulation system to speed up the process of bleeding control1-4. m.doc is a fine powder that rapidly absorbs the blood from minor cuts and grazes to form a soft gel-like layer over the wound to stop bleeding fast. m.doc can assist in the control of bleeding in the numerous superficial dermal injuries that occur in normal day to day activity.
Oxidized cellulose is micronized through a proprietary processes of oxidation, salt balancing, hydrolysis and milling. The final product is a salt of polyanhydroglucuronic acid (PAGA), trademarked as m.doc®. The m.doc salt can be used directly as a powder, can be included as a component of a spray system or is readily included in films and gels.
1. Burkatovskaya M et al. “Use of chitosan bandage to prevent fatal infections developing from highly contaminated wounds in mice.” Biomaterials. 2006 Aug;27(22):4157-64.
2. Data on file, in vitro colony forming unit reduction in antibacterial barrier testing using AATCC Method 100-2004. Tricol Biomedical Inc.
3. Arbel, J., et al., “USage of chitosan for Femoral (USF) haemostasis after percutaneous procedures: a comparative open label study.” EuroIntervention, 2011. 6(9): p. 1104-9.
4. Kale, T.P., et al.., “Effectiveness of Hemcon Dental Dressing versus Conventional Method of Haemostasis in 40 Patients on Oral Antiplatelet Drugs.” Sultan Qaboos Univ Med J, 2012. 12(3): p. 330-5.
5. Misgav, M., et al., ‘Chitosan-based Dressing for the Treatment of External/Accessible Bleedings in Children With Bleeding Tendency.” Journal of Pediatric Hematology/Oncology, 2014. 36(2): p. 140-142.
6. Pippi, R., et al., “The effectiveness of a new method using an extra-alveolar hemostatic agent after dental extractions in older patients on oral anticoagulation treatment: an intrapatient study.” Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 2015. 120(1): p. 15-21.
7. Shikani, A.H., et al., “Endoscopically guided chitosan nasal packing for intractable epistaxis.” American Journal of Rhinology & Allergy, 2011. 25(1): p. 61-63.
8. Grotenhuis, R., et al., “Prehospital use of hemostatic dressings in emergency medical services in the Netherlands: A prospective study of 66 cases.” Injury, 2016. 47: p. 1007-1011.
9. Data on file. Matz, J., “Evaluation of Chitosan as a Possible Carrier Material for Antigenic Proteins or Peptides Indicated by Allergic Wheal/Flare Reactions in Known Shrimp Allergic Subjects”, 2009, Chesapeake Clinical Research: Baltimore. p. 1-21. Tricol Biomedical Inc.
10. Waibel, K.H., et al., “Safety of chitosan bandages in shellfish allergic patients.” Mil Med, 2011. 176(10): p. 1153-6.
11. MacIntyre AD et al. “Hemostatic dressing reduces tourniquet time while maintaining hemorrhage control.” Am Surg. 2011 Feb;77(2):162-5.
12. Schwartz RB et al. “Comparison of two packable hemostatic gauze dressings in a porcine hemorrhage model.” Prehosp Emerg Care. 2011 Oct-Dec;15(4):477-82.
1. Krízová P., et al., “The influence of intrinsic coagulation pathway on blood platelets activation by oxidized cellulose.” J Biomed Mater Res A. 2007 Aug;82(2):274-80.
2. Masova L., et al., “Hemostyptic effect of oxidized cellulose on blood platelets.” Sb Lek. 2003;104(2):231-6.,
3. Rysˇava´a, J.E. et al., “Surface interactions of oxidized cellulose with fibrin(ogen) and blood platelets.” Sensors and Actuators B 90 (2003) 243–249.
4. Jelinkova M., et al. “In vitro and in vivo immunomodulatory effects of microdispersed oxidized cellulose.“ Int Immunopharmacol. 2002 Sep;2(10):1429-41.