Study on the Safety and Effectiveness of Sodium Chloride and Bacteriophage for Treating Surgical Wound Infections in Patients
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and has no marketing authorisation in the product records, meaning it is an investigational substance.[2] The therapeutic area covers bacterial infections and skin and connective tissue diseases.[2]
This kills the bacterium. The trials are designed to show that DUOFAG can reduce the presence of or completely eradicate Staphylococcus aureus and/or Pseudomonas aeruginosa from infected wounds.[2][1]
The product is a cutaneous solution applied topically on the wound.[2] In the Phase 4 trial, the dose is reported as 50,000,000,000 plaque-forming units (PFU) of DUOFAG applied to the wound.[1] The comparator arm in both trials is 0.9% sodium chloride solution applied topically.[2][1]
Two clinical trials are authorised. The Phase 1/2 trial (NCT06319235) enrolled 52 participants and focuses primarily on safety, measuring the frequency of all local and systemic reactions suspected or confirmed to be related to the investigational product.[2] The Phase 4 trial (2025-522752-45-00) enrolled 100 participants and measures safety plus efficacy, defined as the presence and number of S. aureus and/or P. aeruginosa colonies on wound swabs during 14 days of application.[1] The Phase 1/2 trial also measures time to commencement of healing, defined as granulation tissue starting in the wound and eradication of the infection.[2]
The trials are interventional studies. The Phase 1/2 trial includes participants with surgical wound infection or dehiscence caused by S. aureus and/or P. aeruginosa colonisation.[2] The Phase 4 trial includes participants with complicated skin wounds healing by granulation tissue, either infected surgical or traumatic wounds or chronic wounds, all infected with S. aureus and/or P. aeruginosa.[1]
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