In the United States, chronic wounds represent a major public health burden on patients as well as the health care economy. Estimates put the number of chronic wounds cases at over 6.5 million, with a cost burden of over $50 billion. It is estimated that at least two thirds of all chronic wounds are infected with biofilm forming bacteria Recent studies also found that surgical site infections (SSIs) were the most common healthcare- associated infection (HAI), accounting for 31% of all HAIs among hospitalized patients. While advances have been made in infection control practices, SSIs remain a substantial cause of morbidity, prolonged hospitalization, and death and rising economic burdens on the human population. Therefore, there is a critical need for rapid and accurate diagnosis and treatment of the infection in acute or chronic wounds to aid in the proper healing of the wounds themselves. Rapid point-of-care (PoC) pathogen identification (ID) and antimicrobial susceptibility testing (AST) decrease indiscriminate antibiotic use and accelerate pathogen- directed application to avoid inappropriate prescription of antibiotics. MetalloPharm is developing an innovative device that will meet these requirements for a useful PoC product. The specific goal is to develop rapid, low cost, simple-to-use PoC pathogen ID and AST products that provide clinicians with actionable results to aid in wound infection diagnosis and treatment within 1 hour, where the availability of real time data for the practicing physician will make significant differences in th choice and timing of antibiotic treatment. The format is a simple 2-step test involving direct mixing of sample and up to a 1 h waiting period to yield a yes/no color change (Yes/No infection based on a 106 CFU threshold) that is read by the naked eye. There is no requirement for training or special instrumentation, and no need for colony isolation and culture enrichment. Expected Outcome. To provide clinicians with actionable results for wound sample diagnosis, with (1) a rapid PoC pathogen ID within 1 h; (2) an accompanying AST readout. These studies will result in a novel and practical tool for the detection of bacteria in wound samples, especiall because the AST can be performed concurrently. The novelty and high clinical impact of this potential PoC diagnostic will create a paradigm shift in the clinical treatment of wound infection and healing.
Our primary goal is to develop rapid, low cost, simple-to-use PoC pathogen ID and AST products that provide clinicians with actionable results to aid in wound infection diagnosis and treatment within 1 hour, where the availability of real time data for the practicing physician will make significant differences in the choice and timing of antibiotic treatment. The diagnostic is a simple 2-step test involving direct mixing of sample and a 1 hr waiting period to yield a yes/no color change (for Yes/No infection) that is read by the naked eye. There is no requirement for training or special instrumentation, and no need for colony isolation and culture enrichment.
