Infection resulting from bacterial biofilm that forms on the surface of a medical implant represents one of the most serious complications that can follow orthopedic surgery or the implantation of a medical device. Now, a breakthrough technology can kill the dangerous bacteria that proliferate on the surface of a medical implant following surgery, according to the findings of a landmark in vivo research study.
A preclinical research study was conducted to evaluate the efficacy and safety of titanium implants that were treated by DeBogy Molecular, Inc. (Farmington, CT, USA) against the formation of bacterial biofilm. A total of 121 mice were implanted and studied for bacterial attachment on the implant and the level of infection in the surrounding tissue vs. untreated control.
The study revealed that bacterial biofilm on the DeBogy-treated implants was reduced by 99.97% vs. untreated control, seven days following surgery. Bacterial load in the surrounding tissue in animals with DeBogy-treated implants was reduced by 99.8% vs. untreated control, seven days following surgery. The surrounding tissue in animals with DeBogy-treated implants was healthier overall, with decreases in inflammation, fibrosis, vascularization, and necrosis. Excellent clinical health and biocompatibility were recorded in animals with DeBogy-treated implants.
These study results were delivered under a stringent model using a high inoculum of methicillin-resistant Staphylococcus aureus (MRSA) with direct injection into the operative site after skin closure and without the use of antibiotics. This far surpasses most real-world situations for clinical surgical contamination.
“The promise of a new, disruptive technology that can permanently protect the surface of an implantable device from the formation of dangerous bacterial biofilm, without the use of toxic chemicals, coatings or even antibiotics, is truly transformational,” said Wayne Gattinella, CEO of DeBogy Molecular. “The study results affirm that DeBogy technology has the potential to save lives and dramatically improve the quality of life for millions of people, young and old.”
“The bacterial reductions reported on the DeBogy-treated implants and in the surrounding tissues vastly outperformed existing scientific literature on similar animal models using conventional treatment,” said Dr. Houssam Bouloussa, spine surgeon and cofounder, DeBogy Molecular. “This technology has the potential to revolutionize the way we prevent and treat surgical-site infections.”
Related Links: DeBogy Molecular, Inc.