BACKGROUND
In conditions of increasing bacterial resistance to antibiotics, bacteriophages are becoming particularly important as a promising tool for combating surgical infection of the skin and soft tissues. Scientific studies in recent years have demonstrated the effectiveness of phage therapy both as a treatment method and in order to prevent the development of nosocomial infectious complications, including infections caused by multidrug-resistant strains of microorganisms.
OBJECTIVE
The aim of the study was a comparative clinical, cytomorphological and microbiological analysis of the efficacy and safety of phage therapy in the treatment of purulent wounds of various etiologies and localization in patients over 18 years of age.
MATERIALS AND METHODS
The article presents the results of a prospective randomized comparative clinical trial of 80 adult patients with purulent wounds of various etiologies and localization treated at the Department of Wounds and Wound Infections of the A.V. Vishnevsky National Medical Research Center of Surgery of the Ministry of Health of the Russian Federation in 2022—2024 (LEK conclusion No. 7/2NIR-22 dated 05/31/2022). During the study, clinical (edema, pain, the nature of wound discharge, the appearance of granulation tissue), laboratory (the presence and regression of signs of a systemic inflammatory response to the presence of a surgical infection), microbiological (qualitative and quantitative), cytological and morphological parameters were analyzed in all patients. Parametric data were evaluated based on the mean and standard deviation (SD) at 4 study points: point 1 (1±1 day), point 2 (3±1 day), point 3 (7±1 day) and point 4 (9±1 day) after surgical treatment of the purulent focus. The key endpoint was the transition of the wound healing process into the regeneration phase.
RESULTS
According to the study protocol, all the patients included in the analysis had purulent-necrotic wounds of soft tissues and bones of different etiology and localization, requiring surgical treatment. To distribute patients into groups, upon admission or intraoperatively, material was collected for qualitative and quantitative microbiological, cytological, morphological and electron microscopic studies. Randomization was carried out using the pseudorandomization method, patients were selected in a 1:1 ratio based on an assessment of the sensitivity of isolated cultures to the drug “Piobacteriophage complex” liquid (Piophage, NPO Microgen JSC, Russia). In the postoperative period, patients of group I (n=20) received systemic and local phage therapy (20 ml 3 times per day, according to the instructions); in subgroup Ia (n=20), bacteriophages were delivered to the focus using negative pressure devices with instillation (–120 mm Hg, permanent mode, VitMedical, Russia); in group II (n=20), systemic and local antibacterial therapy was performed; in group III (n=20)— systemic treatment with local negative pressure (–120 mmHg, permanent mode, VitMedical, Russia).
An analysis of the treatment results indicates the high effectiveness of the proposed protocol in all study groups. In group 1a (local negative pressure with bacteriophage instillation in combination with systemic phage therapy) The best microbiological, cytological, morphological and clinical efficacy was noted, indicating the potentiation of both methods of treating purulent wounds of various etiology and localization (the first signs of relief of the inflammatory phase were noted by 3±1 days after surgery). In general, key endpoints (the transition of the wound healing process to the regeneration phase) were achieved in all the studied groups with good tolerability of therapy and a high safety profile. No additional surgical interventions were required in any group, and no deaths were reported. No adverse events requiring discontinuation or change of treatment option were identified.
CONCLUSION
The principles of purulent wounds treatment in our country are based on the method of active surgical treatment developed in the Department of Wounds and Wound Infections of the Vishnevsky Institute of Surgery (now the Vishnevsky National Research Medical Center of Surgery of the Ministry of Health of the Russian Federation). The results of treatment largely depend on the radicality and thoroughness of the primary surgical debridement of the purulent focus, general and local treatment in the perioperative period. The inclusion of bacteriophages in treatment regimens, especially in combination with local negative pressure, allows for a more pronounced antimicrobial and regenerative effect, which makes this approach promising in the treatment of purulent-inflammatory diseases. The combination of active surgical treatment with local negative pressure therapy and bacteriophage instillation demonstrates pronounced synergy: surgical treatment of purulent wounds reduces microbial contamination and destroys biofilms, which increases the availability of phages. In turn, their bacteriolytic and bacteriostatic activity prevents re-colonization and promotes the transition of the wound process to the regeneration phase, which is especially important in the presence of polyresistance.
