Comparative assessment of the effectiveness and safety of combined drugs in wound healing and prevention of wound infection after explosive and gunshot injuries

BACKGROUND: Infected wounds, including the consequences of explosive and gunshot injuries, as well as diabetic foot syndrome, represent a serious medical problem due to the high risk of complications and long-term patient care. In this regard, the search for effective and safe methods of local therapy remains relevant. In this study a comparative assessment of the effectiveness of the use of some combined antibacterial drugs and antiseptic agents in the treatment of such wounds was carried out, with an analysis of their effect on tissue regeneration, microbial load and clinical outcomes.

AIM: To evaluate the efficacy and safety of the combined drugs of Dioxomethyltetrahydropyrimidine + Lidocaine + Ofloxacin; Dioxomethyltetrahydropyrimidine + Chloramphenicol and Povidone-Iodine in the treatment of infected wounds of various origins.

METHODS: A single-center, open, non-interventional, observational, randomized, controlled study was conducted involving 60 patients (40 with explosive / gunshot wounds and 20 with diabetic foot syndrome). Three drugs were selected for comparison (Dioxomethyltetrahydropyrimidine + Lidocaine + Ofloxacin, Oflomelid, “Sintez” PJSC, Russia; Dioxomethyltetrahydropyrimidine + Chloramphenicol, Levomikol, Nizhpharm JSC, Russia, and Povidone-Iodine, Betadine, Egis Pharmaceuticals PLC, Hungary). The treatment included daily wound care during the observation period. The dynamics of wound healing (area, depth, volume of exudation), pain syndrome, microbiological and biochemical parameters were evaluated.

RESULTS: The use of the combination Dioxomethyltetrahydropyrimidine + Lidocaine + Ofloxacin was accompanied by statistically more pronounced results in the dynamics of wound healing: a decrease in the area (p <0.001) and depth (p=0.008) of wounds, as well as the intensity of exudation (72.7% of patients without exudate by the 4^th visit). When assessing pain syndrome, the reduction of pain was more pronounced in the group of the combination Dioxomethyltetrahydropyrimidine + Lidocaine + Ofloxacin (p <0.001). All drugs effectively suppressed the growth of Staphylococcus aureus, but combined antibacterial agents demonstrated 20% better results compared to antiseptic agent. Laboratory parameters improved in all groups, but anti-streptolysin-O decreased significantly when using the combination of Dioxomethyltetrahydropyrimidine + Lidocaine + Ofloxacin (p=0.009).

CONCLUSION: All the studied drugs are effective and safe, but the combination of Dioxomethyltetrahydropyrimidine + Lidocaine + Ofloxacin demonstrated the best results in terms of key parameters: accelerated healing, reduced bacterial load, and improved subjective assessments. Its combined composition (antibiotic + regenerant + anesthetic) makes it the preferred choice for complex infected wounds treatment, including the consequences of injuries and diabetic foot.