Before performing a laparoscopic colectomy, Harry Papaconstantinou, MD, FACS, entered his patient’s risk factors into the American College of Surgeons (ACS) Surgical Risk Calculator. The patient, an 80-year-old gentleman with a 7-cm tumor growing in his colon, had multiple issues that made surgery more complicated—diabetes, hypertension and chronic obstructive pulmonary disease. He was also obese and a smoker. The ACS calculator put his surgical site infection (SSI) risk at 14%.
Given the patient’s risk profile, Dr. Papaconstantinou, chairman of the Department of Surgery and chief of colorectal surgery at Baylor Scott & White Health, in Temple, Texas, wanted additional backup. The extensive pre-, intra- and postoperative protocols that surgeons routinely employ to manage wounds do not consistently prevent SSIs. According to the Centers for Disease Control and Prevention, SSIs represent the most common nosocomial infections, affecting almost 300,000 patients each year. Plus, these infections are expensive to treat. Recent analyses have shown that an SSI adds approximately $20,000 to a patient’s treatment costs, which amounts to billions of dollars a year in potentially avoidable health care expenses (Patient Saf Surg 2014;8:42).
To tackle the persistent SSI problem, Dr. Papaconstantinou joined forces with a team of researchers at Prescient Surgical, a startup tech company dedicated to finding solutions in the SSI arena. The core Prescient Surgical team—CEO and President Jonathan Coe; Mark Welton, MD, chief of colon and rectal surgery at Stanford University, in California; endocrine and general surgeon Insoo Suh, MD; and engineer Jeremy Koehler—developed a device called CleanCision to reduce the risk for infections.
Surgeons and device experts have been trying to crack the SSI nut for years. So what makes CleanCision unique? The investigational device has elements of existing products: It is a retractable plastic sleeve, sandwiched by two flexible rings, that can cover and protect the wound. CleanCision, however, adds an extra layer of protection.
“This is first device with the capacity to pump an antibiotic solution through pores in the protective sheet,” said Cindy Kin, MD, assistant professor of surgery at Stanford University School of Medicine, who has advised the company on early prototypes.
The infusion of antibiotics can theoretically reduce the chance that bacteria from the skin or bowel will colonize the wound. In a feasibility study, the Prescient Surgical team found that combining antimicrobial delivery and wound protection in a porcine model compared with barrier wound protection alone significantly reduced the bacterial load by nearly 100-fold.
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