By Industry News
Jacksonville, FL – August 11, 2021 – Next Science Limited pleased to announce that a clinical trial has been initiated in the U.S. for XPERIENCE™ No Rinse Antimicrobial Solution. Enrollment in the 30-patient, 90-day study is currently underway.
The trial, 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.
The study’s primary investigator is Dr. Robert Harris, an orthopaedic trauma surgeon with the Hughston Clinic in Columbus, Georgia. In addition to serving as the director of orthopaedic trauma for the Hughston Clinic, Dr. Harris is a fellow of the American Academy of Orthopaedic Surgeons and a member of several orthopaedic surgery associations, including the American Orthopaedic Association, the Orthopaedic Trauma Association and the Society of Military Orthopaedic Surgeons.
XPERIENCE is a no-rinse solution that 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.1,2 Biofilms account for more than 80% of microbial infections in the human body,3 according to the U.S. National Institutes of Health.
“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.4”
In April, Next Science announced it had received 510(k) clearance from the Food and Drug Administration for the sale of XPERIENCE as a medical device in the U.S. XPERIENCE is predominantly used in orthopaedic procedures, including shoulder, hip, knee, trauma and podiatry surgeries. Future studies will look at expanding current indications.
XPERIENCE is the newest product from Next Science, whose mission is to address the impact of biofilms on human health. Each of these products is powered by XBIO™ Technology, which disrupts biofilm’s extracellular polymeric substance and makes the bacteria within the biofilm more vulnerable to attack.
1. International Wound Infection Institute (IWII) Wound infection in clinical practice. Wounds International.
2. Hall-Stoodley L, Stoodley P. Evolving concepts in biofilm infections. Cell Microbiol. 2009;11(7):1034-43.
3. Joo HS, Otto M. Molecular basis of in-vivo biofilm formation by bacterial pathogens. Chemistry & Biology. 2012;19(12):1503-1513.
4. Zimlichman, E., et al., “Health Care-Associated Infections. A Meta-analysis of Costs and Financial Impact on the US Health Care System”. JAMA Intern Med, 173(22): (2013): 2039-46.
About Next Science
Next Science develops innovative technologies that apply materials science principles to address, and ultimately resolve, one of the leading causes of antimicrobial resistance: bacterial biofilms.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, HMP Global, its affiliates, or subsidiary companies.