Novel Tibial Fracture Infection Study Announced
How well can a no rinse antimicrobial solution prevent infection in open tibial shaft fracture trauma cases—which typically have a 25% infection rate?
Primary investigator Robert Harris, M.D., director of orthopedic trauma at the Hughston Clinic in Columbus, Georgia, organized a Level 1 prospective, double blinded, controlled pilot clinical study to test this question—the first time such a study has been launched.
Dr. Harris intends to collect data regarding the efficacy and safety profile of a novel, no rinse antimicrobial solution to treat Type II-IIIB contamination. Saline washout will serve as the control at the time of fracture fixation.
The sponsor of the study is Jacksonville, Florida based Next Science Limited, the manufacturer of the tested product which is brand named “XPERIENCE.”
The investigators intend to quantify the ability of such an antimicrobial solution to cut wound bioburden and surgical site infections and, thereby, improve post-operative outcomes when used as adjunct treatment to standard of care in patients undergoing tibial fracture repair.
According to Dr. Harris: "The primary outcomes will compare surgical site infection rates and study the safety profile of the use of XPERIENCE in this clinical setting. Secondary outcomes will be time to fracture union and secondary procedures to achieve union. The trial is underway, and several patients have been enrolled. Research assistants ensure the adherence to protocol and follow up with accurate data input allowing the treating surgeons to provide better clinical assessments."
“This is the first Level I clinical trial of its kind in an open fracture clinical model that has infection rates as high as 25%, evaluating the effects of XPERIENCE in potentially helping to reduce surgical site infections. Given the knowledge of biofilms and how rapidly they are established in the wound, this novel approach to biofilm destruction may be the key to helping with infection prevention in the acute setting for both open and closed fractures. Once this study is complete, larger multicenter studies will be required to evaluate the true value of this potential weapon in the fight against orthopedic infections.”
According to the study sponsor and its Managing Director Judith Mitchell, “The start of this trial is a significant milestone in the clinical development of XPERIENCE and for the evolution of our company. 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.”