ANTI-ADHESIVE MEMBRANES FOR CARDIOVASCULAR SURGERY - EFFICACY EVALUATION IN A LARGE ANIMALS STUDY

Highlights Formation of adhesions after chest surgery remains an unresolved issue. The use of biodegradable anti-adhesion membranes with anti-inflammatory activity can reduce the risk of adhesion. Preclinical assessment of the developed membranes in a large laboratory animal model is a mandatory step in the development of a medical device. Aim. To conduct a preclinical evaluation of the effectiveness of an anti-adhesive biodegradable membrane with anti-inflammatory activity in a large laboratory animal model (sheep). Methods . A composition of biodegradable polymers was used to manufacture the membranes: polylactide-co-glycolide copolymer (50:50) Mm 20–30 kDa and polylactide-co-glycolide (85:15). The polymers were dissolved in 1,1,1,3,3,3-hexafluoroisopropanol. To impart anti-inflammatory properties to the membrane, dexamethasone (DM) was added to the membrane composition at a final concentration of 1 mg DM/1 ml of polymer solution. The membranes were manufactured by electrospinning. The anti-adhesion efficiency of the membranes was assessed on an animal model (sheep) during implantation into the chest cavity. Results. In the control group of animals, a massive adhesive process was noted. In the experimental group, six animals (66.6%) had no adhesions at all, two animals (22.2%) had weak adhesion of the lung and pericardium in the area of ​​membrane fixation with suture material, and one animal (11.1%) had moderate adhesion of the pericardium to the surface of the chest cavity. Conclusion. The developed biodegradable membranes have demonstrated satisfactory anti-adhesive activity (88.8%). The implantation experience showed that it is better to use a membrane 30% larger in size than necessary to properly close the wound.