Prescient Surgical announced publication of clinical data in Surgical Infections on CleanCision, its novel irrigating wound retraction and protection system, which is commercially available in the U.S. and approved for use in Europe.
The study demonstrated that use of the CleanCision device in elective colorectal surgery patients showed a 61 percent reduction in SSI (p=0.04). The observed rate of SSI in a prospective study using the CleanCision device was 3.7 percent. Whereas, the predicted rate of SSI in the same patient population utilizing the National Surgical Quality Improvement Program (NSQIP) Risk Calculator was estimated to be 9.5 percent.
“These study results present a compelling case for bringing together surgical site infection prevention best practices of irrigation and barrier protection into a single, easy to deploy technology,” says Harry Papaconstantinou, MD, Chair, Department of Surgery at Temple, Texas-based Baylor Scott & White Healthcare, colorectal surgeon, and principal investigator in the trial. “If we want to protect our patients from infection and achieve zero preventable infections, we need to keep driving forward with advanced tools and technologies like CleanCision.”
Colorectal surgery is notorious for its high rates of SSI. Due to the nature of the surgery, there is high likelihood of contamination of the surgical incision site. It has been shown that up to 50 percent of all abdominal incisions may be contaminated during colon surgery.
“The battle to reduce infection in patients undergoing colorectal surgery is still ongoing,” says Roberto Bergamaschi, MD, PhD, Professor and Chief, Colorectal Surgery at New York Medical College / Westchester Medical Center and investigator in the trial. “This study is important because it informs us about the ability for a new technology to impact surgical site infection as compared to the standard of care.”
The study was a retrospective analysis comparing the rate of SSI observed in a prospective cohort study to the predicted rate of SSI using the NSQIP Risk Calculator. A prospective multi-center clinical study was previously conducted using the CleanCision device in a cohort of elective colorectal surgery patients undergoing a resection. Patients were followed for 30 days for evaluation of SSI using the CDC definitions. After completion of the initial study, patients’ characteristics were inserted into the NSQIP Risk Calculator to determine the predicted rate of SSI for the given patient population and compared with the observed rate in the prospective study. The study was conducted at seven centers in the United States. There were a total of 108 subjects eligible for analysis.