RESUMO
BACKGROUND: Chronic wounds are prevalent globally at endemic proportions. The common features associated with chronic wounds are prolonged inflammatory phase, infection with multidrug-resistant (MDR) bacteria, and subsequent biofilm formation. The present randomized-controlled trial (RCT) study was undertaken on chronic wounds of ≥6 weeks longer duration using customized phages to evaluate the efficacy and safety of bacteriophage therapy. METHODS: The study was conducted from December 2021 to August 2023. Thirty patients in each of the arms (placebo and bacteriophage) were recruited with chronic wounds. The patients, both arms, received the conventional treatment of wound debridement, local antiseptics, and local and systemic antibiotics at the discretion of the treating surgeon. However, before applying the customized bacteriophage cocktail or placebo, the wound surface was thoroughly washed to remove the residual antiseptics. The phage cocktails or placebo were applied on alternate days. The wounds were evaluated using the Bates-Jensen Wound Assessment Tool for the progress of wound healing. RESULTS: A total of 93.3% of the wound became sterile in 39 days (median sterility time), followed by complete healing by the end of 90 days in the phage group. Contrary to this, 83.3% of those on placebo therapy remained colonized by original bacteria or additional new bacteria without healing for up to 90 days. CONCLUSION: With the well-designed RCT, we could conclude that customized bacteriophage therapy using bacteriophage cocktails will definitely cure the chronic wound, irrespective of age, sex, diabetes status, and infection by MDR bacteria.
RESUMO
The recent approval of experimental phage therapies by the FDA and other regulatory bodies with expanded access in cases in the United States and other nations caught the attention of the media and the general public, generating enthusiasm for phage therapy. It started to alter the situation so that more medical professionals are willing to use phage therapies with conventional antibiotics. However, more study is required to fully comprehend phage therapy's potential advantages and restrictions, which is still a relatively new field in medicine. It shows promise, nevertheless, as a secure and prosperous substitute for antibiotics when treating bacterial illnesses in animals and humans. Because of their uniqueness, phage disinfection is excellent for ready-to-eat (RTE) foods like milk, vegetables, and meat products. The traditional farm-to-fork method can be used throughout the food chain to employ bacteriophages to prevent food infections at all production stages. Phage therapy improves clinical outcomes in animal models and lowers bacterial burdens in numerous preclinical investigations. The potential of phage resistance and the need to make sure that enough phages are delivered to the infection site are obstacles to employing phages in vivo. However, according to preclinical studies, phages appear to be a promising alternative to antibiotics for treating bacterial infections in vivo. Phage therapy used with compassion (a profound understanding of and empathy for another's suffering) has recently grown with many case reports of supposedly treated patients and clinical trials. This review summarizes the knowledge on the uses of phages in various fields, such as the food industry, preclinical research, and clinical settings. It also includes a list of FDA-approved bacteriophage-based products, commercial phage products, and a global list of companies that use phages for therapeutic purposes.