Next Science commenced a clinical trial in the U.S. for XPERIENCE No Rinse Antimicrobial Solution. Enrollment in the 30-patient, 90-day study is underway.
The TIFRAX (Tibial Fracture) Study is a randomized, controlled, double-blinded, prospective study to evaluate the efficacy of XPERIENCE in helping decrease wound bioburden and surgical site infections (SSI). It will also evaluate whether XPERIENCE can improve post-operative outcomes when used as adjunct treatment to standard of care in patients undergoing tibial fracture repair.
XPERIENCE is designed to help prevent surgical site and post-operative infections by rinsing away debris and microorganisms. XPERIENCE breaks down biofilms, which are powerful communities of bacteria that function as a single entity with behaviors and defenses that are a leading contributor to SSIs.
“The start of this trial is a significant milestone in the clinical development of XPERIENCE and for the evolution of our company,” said Managing Director Judith Mitchell. “Next Science has a unique opportunity to change the trajectory of the war on infection by providing solutions that eliminate biofilms, and their incumbent bacteria. The results of this clinical trial will help in the global fight against surgical site infections, which in the U.S. alone contribute an additional $3.5 billion annually to the cost of healthcare.”
In April, Next Science received FDA 510(k) clearance to market XPERIENCE. XPERIENCE is predominantly used in orthopaedic procedures, including shoulder, hip, knee, trauma and podiatry surgeries. Future studies will look at expanding current indications.
