Differentiating between inflammation and infection near or on surgical implants is a daily struggle for surgeons.
Differentiating between inflammation (normal) and infection (not normal) after placing a surgical implant is crucial. The latter requires immediate treatment, preferably before the biofilm forms, to reduce mobility and mortality. And an inflammation should not be treated with antibiotics, adding to the already existing global antibiotic resistance.
The challenge is to treat patients with an actual infection appropriately, while at the same time, not over-treating patients who only have an inflammation (i.e. non-bacterial) with antibiotics.
An inflammation over-treated with antibiotics feeds the global antibiotic resistance issue, which is a focal point of the WHO. Keeping patients with a normal inflammation unnecessarily hospitalized has significant financial implications on the payer, the hospital, and, of course, the patient. On the other hand, missing the treatment window of infection before the biofilm forms results in increased patient morbidity, mortality, and a 400% increase in treatment cost (compared to the cost of the initial procedure).
Over 2 million Osteosynthesis devices (OD’s) are used in the USA every year
Of the 2 million Osteosynthesis devices (OD’s) that are implanted in the USA every year, on average 5% of these devices become infected. The incidence of infection of closed fracture implants is reported to be between 5-10%, but the prevalence of infection of open fracture implants exceeds 30%.
Direct additional costs related to these infections are estimated at US$ 45,000 per case. This adds up to an additional financial burden of US$ 3.2 billion per year, in the USA only.
This challenge of differentiating between something that doesn’t require treatment (inflammation) and something that does (infection) is industry-wide.
When a fracture is stabilized with an orthopedic plate on (for instance) an ankle, the wound is often swollen, red, and tender. This is a normal inflammatory physiological reaction. However, distinguishing between this normal reaction and an infection caused by bacterial presence can be difficult, especially in the early stages.
All surgeons and doctors struggle with this problem, as indicated by all current medical literature. And the consequences of misdiagnosing are serious, as it increases morbidity and mortality for patients, but also puts a significant financial burden on an already strained healthcare system.
The BactoTact©OR, is our bio-degradable sponge that can be left behind in the humanbody after an operation and can show real-time bacterial presence if an infection occurs.