Medical device developer Next Science has conducted a clinical trial in the US for XPERIENCE, its new no-rinse antimicrobial solution to prevent surgical site infections.
The US clinical trial comes after Next Science secured a 510(k) clearance from the US Food and Drug Administration for XPERIENCE last April 2021. According to a press release from the medical technology company, the trial will be a TIFRAX (tibial fracture) study, a randomized, controlled, double-blind, prospective study that would evaluate the efficiency of the no-rinse antimicrobial solution against wound bioburden and risks of surgical site infections.
Additionally, the test also aims to see if XPERIENCE can improve postoperative outcomes when used as an adjunct treatment procedure to the standard of care in patients undergoing tibial fracture repair.
The primary investigator for the Next Science clinical trial is Dr. Robert Harris, an orthopedic trauma surgeon currently with the Hughston Clinic in Columbus, Georgia. He is also a fellow with the American Academy of Orthopaedic Surgeons. He is a member of various orthopedic surgery associations such as the Orthopaedic Trauma Association, the Society of Military Orthopaedic Surgeons, and the American Orthopaedic Association.
About XPERIENCE
XPERIENCE is a no-rinse solution developed by Next Science, intended to help prevent postoperative and surgical site infections by washing away microorganisms and other debris on-site - all by deactivating biofilms. According to Brenner's Encyclopedia of Genetics, biofilms are surface-attached and structured communities of microbes containing pathogens. These communities act as a single entity with defenses and behaviors that lead to surgical site infections, according to a 2009 study.
"The start of this trial is a significant milestone in the clinical development of XPERIENCE and for the evolution of our company," said Judith Mitchell, Managing Director for Next Science. She adds that Next Science has the unique opportunity to change the direction of the ongoing war against infections by eliminating biofilms and the bacteria that dwell within them. Mitchell also notes that the clinical trial could help advance this fight, which adds $3.5 billion to healthcare costs in the US every year, citing data from a 2013 study in the JAMA Intern Med journal.
XPERIENCE is built on XBIO Technology, a proprietary tech from the company that disrupts the extracellular polymeric substances in biofilms, weakening the bacteria within and subsequently the biofilms themselves.
Last April, Next Science announced securing the 510(k) clearance from the US FDA to sell XPERIENCE as a medical device across the United States. XPERIENCE was designed for use in orthopedic procedures, including traumas in the shoulder, hip, knee, trauma, and podiatry surgeries. Future studies could help expand current indications for the solution.
About Next Science
Headquartered in Sydney, Australia, Next Science is a medical technology company with a research and development facility in Florida, USA. Founded in 2012, the company primarily focuses on developing products based on its proprietary XBIO Technology and brings them to the wider market. Its products and solutions aim to reduce biofilm-based infections and their other adverse effects on human health.
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