2. Material and Methods
swelling, allergy, painless, gangrene, necrotic, pain, purulent, infection, necrosis, ulcerations, ulcer
ACUTE ISCHEMIA, GENERALIZED INFECTION, ALLERGY, ULCERS, POLAND, NECROSIS, VASCULARIZATION, DEEP VEIN THROMBOSIS, GANGRENE, NECROTIC, INFECTION; LOCAL, INFECTION, ULCERATION, ULCER, ATROPHIC, COMPLICATIONS, INFILTRATION, ARTERIAL LEG ULCERS, ULCERATIONS
The study included 30 patients (13 women and 17 men) aged 47–80, hospitalized in the Department of Internal Medicine, Angiology and Physical Medicine in Bytom with a diagnosis of arterial ulceration of the lower limbs, who had no indications for vascular revascularization.After collecting their medical history and performing a physical examination, the patients were randomly (one-to-one) assigned to two study groups. Group 1 (16 patients) was treated with specialist ATRAUMAN Ag dressings and local hyperbaric oxygen therapy procedures. In group 2 (14 patients), only specialized ATRAUMAN Ag medical dressings were used. The treatment was carried out for a total of 4 weeks.The use of ATRAUMAN Ag dressings was dictated by the current recommendations for their use. It is a specialist dressing that does not stick to the wound, and thus allows for its painless removal, which is not without significance in the case of coexisting pain. In addition, these dressings provide good ventilation and oxygenation of the wound, which accelerate healing and minimizes the risk of complications. In addition, the constant release of silver ions into the wound bed stabilizes bacterial activity at a low level, and the creation and maintenance of an optimal moist wound environment stimulates the autolysis of necrosis and the formation of new granulation tissue.The mean age of patients in group 1 (66.31 ± 7.7 years) did not differ statistically significantly as compared to group 2 (64.85 ± 10.09 years) (The ulceration conditions in both groups were comparable. The ulcerations were located above the lateral or medial malleolus. The surface of the wounds was usually covered with pale yellow fibrin with single necrotic hyphae. The wounds were characterized by atrophic changes. The skin around the ulcerations was parchment-like, shiny, with an unpleasant odor, a slight exudation, and an admixture of purulent secretion. In both groups, the ulceration area and depth (small shallow ulcer on distal leg, no exposed bone, no gangrene), incidence of infection (mild clinical manifestation of infection; local swelling and opaque to white secretion) and ABI index values (0.6–0.79) were all, in both groups, in grade 1, according to the WIfl Classification System [The inclusion criteria for the study were as follows: arterial leg ulcers of the lower limbs, age ≥47 and ≤80 years, lack of qualification for vascular revascularization, and voluntary patient consent to participate in the study. Exclusion criteria from the study were as follows: etiology of ulcers other than arterial, deep vein thrombosis, acute ischemia of the lower limbs, qualification for vascular vascularization, age <47 and >80 years, generalized infection, contraindications to hyperbaric oxygen therapy treatments, allergy to silver, and a lack of patient consent to participate in the study.Prior to the treatment implementation, each patient from both study groups underwent a Doppler ultrasound examination (in order to determine the etiology of the ulceration). A surgical consultation was also performed in each patient. In the case of necrotic tissue or purulent infiltration within the ulceration, surgical wound debridement was performed before inclusion to the study.Specialized dressings were changed every three days in both study groups. The dressings used in the study had the properties to ensure a moist environment conducive to accelerating the healing of ulcers. They did not require daily replacement and at the time of their change, they did not damage the newly formed granulation tissue. The only contraindication to their use during the studies was the previously diagnosed allergy of patients to the active substance contained in them (silver ions).The OXYBARIA-S device (manufacturer Firma FASER S.A., Świętochłowice, Poland) was used for local hyperbaric oxygen therapy [During the treatment, various forms of standard pharmacotherapy were used (pentoxifylline, sulodexide, and local antiseptic therapy). No antibiotics were administered before or during the evaluation period.The study protocol was approved by the local bioethics committee of the Medical University of Silesia in Katowice (approval number: KNW/0022/KB1/102/II/16/19). Each patient signed a written informed consent to participate in the study.