SBIR-STTR Award

Staphylococcus aureus wound infections are the most common infections that occur in humans resulting in delayed and poor wound healing, sepsis and death. They are the most common causative bacteria in acute wound infections as well as chronic wound infections. Unfortunately, Staphylococcus aureus in the general population has developed significant resistance to all commonly used oral antibiotics with over 90 percent of strains being methicilllin resistant. Furthermore, standard scrubbing techniques of wounds with povodine- iodine solutions do not affect the bacterial counts of staphylococcus aureus in open wounds. Photodynamic therapy (PDT) is a modality that involves the use of a photosensitizing agent and laser light to create oxygen radicals resulting in the destruction of cancer cells, bacteria, viruses as well as fungi. Several dyes commonly used in medical practice are excellent photodynamic agents ie, methylene blue and toluidene blue. These agents in combination with the appropriate wavelength of light have resulted in the destruction of antibiotic resistant staphylococcus aureus. The proposed research will attempt to establish the feasibility of PDT treatment with topical dyes as a means to antiseptically treat acutely infected wounds in an animal model, demonstrating the effectiveness, ease and minimal morbidity of this treatment. PROPOSED COMMERCIAL APPLICATION The longterm objective of the proposed research is to develop PDT treatment devices with topical dyes as a primary antisepsis treatment for acute wounds as well as a treatment for chronically infected wounds. As this treatment has a different mechanism of action than topical and systemic antibiotics, it will also reduce the significant problem of developing antibiotic resistance.

Thesaurus Terms:
Staphylococcus aureus, Staphylococcus infection, antibiotic, biomedical equipment development, laser, photosensitizing agent biotechnology, clinical biomedical equipment, dye, free radical oxygen, nonhuman therapy evaluation guinea pig, histologyNational Institute of Allergy and Infectious Diseases (NIAID)

Ventilator-associated pneumonia (VAP) is a common, significant, life threatening and unaddressed infectious disease problem that occurs in patients who are intubated with an endotracheal tube and require mechanical ventilation. Of the l .6 million patients per year in the US who require mechanical ventilation, 15-25% will develop VAP and 24-71% will die of the disease. In addition, VAP costs the US healthcare industry $1.2 billion dollars annually. A major cause of VAP is the proliferation of microorganisms and microbial biofilm on the interior of the endotracheal tube, which during mechanical ventilation is dislodged into the lung resulting in tracheobronchitis and pneumonia. The primary objective of the proposed SBIR-AT-NIAID project is to perform a controlled, double armed, multi-institutional IRB approved human clinical trial to determine the safety and efficacy of using Photodynamic Therapy (PDT) to reduce endotracheal tube microorganisms and associated biofilm. The reduction of the endotracheal tube microorganisms is expected to result in a significant reduction of the incidence of VAP with reduced morbidity, mortality, length of hospital stay and overall cost of treatment. PDT is a treatment modality that combines the use of a photosensitizing solution and light to create oxygen radicals resulting in the destruction of microorganisms. Advanced Photodynamic Technologies, Inc. has developed and optimized a PDT System that has been proven to be effective in the broad spectrum eradication of antibiotic resistant pathogenic bacteria, fungi and biofilms during in vitro, ex vivo and in vivo experiments. In addition, the safety of the proposed photosensitizer solution and light combination has been established in a GLP controlled large mammal study. The proposed clinical study will demonstrate the safety and efficacy of PDT treatment as a means to reduce endotracheal tube biofilm resulting in a reduction in the incidence of VAP. The proposed PDT System is unique in that no effective alternative treatment of endotracheal tube microbial biofilms is currently available for clinical use