Innovative biologically active wound healing and hemostatic agents based on chitosan and collagen: development stages, medical and technical characteristics

Abstract

Preservation of a consistently high number of domestic, industrial or military injuries, trophic ulcers, pressure sores, chronic wound defects in the morbidity structure makes the problem of effective and physiological healing of wounds extremely urgent. One of the most promising directions for solving this problem is the creation of wound healing and hemostatic agents of high efficiency (in comparison with traditional dressings from cellulose and non-woven textile materials) based on biologically active high-molecular natural and synthetic polymers with the immobilization of drugs with antibacterial, analgesic and necrolytic effects.Object: development of innovative biologically active wound healing and hemostatic agents based on chitosan and collagen.Materials and methods. As materials for determining medical and technical characteristics, new wound products were investigated: - means “Chitocol” performed by “Chitocol-S”, “Chitocol-CS”, “Chitocol-DA”, “Chitocol-CDA”, “Chitocol-SC”, “Chitocol-SCD”, sterile, “Chitocol-CSC”, “Chitocol-CSCD” with immobilized substances of colloidal silver, dioxidine and chymotrypsin; - means “Chitocol-Hemo” performed “Chitocol-Hemo C”, “Chitocol-Hemo CS”, “Chitocol-Hemo”, “Chitocol-Hemo S” with the immobilized substance colloidal silver. A preliminary preclinical evaluation of the effectiveness of the wound healing and antimicrobial effects of the prototype “Chitocol-CDA”, “Chitocol-CS” and “Chitocol-CSC” (porous plates 2×2×0.4 cm in size) in vivo was performed on white male Wistar rats weighing 180–200 g. The healing efficiency was evaluated on the basis of planimetric, hematological, histological research methods.Results. Quantitative indicators of medical and technical characteristics of the “Chitocol” and “Chitocol-Hemo” for use in the development of regulatory, technological and operational documentation on medical devices. An experimental study of wound dressings “Chitocol-CS”, “Chitocol-CDA” and “Chitocol-CSC” showed that their use leads to a reduction in the area of wounds by more than 90 % by 15 days of treatment, the maximum healing speed when applying the first two samples accounted for the first phase of the wound process (1–5 days), and in the group with purulent-necrotic process on 10–15 days of treatment. In the treatment of clean and infected wounds with the “Chitocol-CS” and “Chitocol-CDA” samples, complete healing and completion of the epithelization process began by 15 days, and in the group using “Chitocol-CSC” the proliferative phase of inflammation was in full swing.Conclusion. Quantitative indicators of medical and technical characteristics of innovative biologically active wound healing and hemostatic agents based on a (bio) polyelectrolyte complex of chitosan and collagen or chitosan with immobilized antimicrobial (dioxidine, colloidal silver), analgesic (anilokain) and proteolytic (chymotrypsin) positive results, as well preliminary preclinical study of wound healing agents with dioxidine and anilokain (“Chitocol-CDA”), colloidal silver (“Chitocol-CS”), colloidal silver and chymotrypsin (“Chitocol-CSC”) provide the basis for continuing work on toxicological, acceptance technical preclinical and clinical trials with the aim of experimental confirmation of the expected effectiveness and safety of the developed products.